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Patrick M M Bossuyt - One of the best experts on this subject based on the ideXlab platform.
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treatment of tubal pregnancy in the netherlands an economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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Treatment of tubal pregnancy in The Netherlands: An economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy ☆ ☆☆ ★
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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systemic methotrexate therapy versus laparoscopic Salpingostomy in patients with tubal pregnancy part i impact on patients health related quality of life
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic Salpingostomy for tubal pregnancy. Design: Multicenter randomized clinical trial. Setting: Departments of obstetrics and gynecology of six Dutch hospitals. Patient(s): Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic Salpingostomy. Intervention(s): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks, and 16 weeks after confirmative laparoscopy. Main Outcome Measure(s): Health-related quality of life. Result(s): Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic Salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. Conclusion(s): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic Salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.
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systemic methotrexate therapy versus laparoscopic Salpingostomy in tubal pregnancy part ii patient preferences for systemic methotrexate
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To investigate patient preferences for systemic methotrexate therapy relative to laparoscopic Salpingostomy in the treatment of tubal pregnancy. Design: Preference assessment in controlled clinical study. Setting: Four hospitals and one infertility clinic. Patient(s): Forty patients who had been treated for tubal pregnancy and 40 nonpregnant controls. Intervention(s): Preference for methotrexate therapy relative to Salpingostomy was established during an interview. Two scenarios were offered for methotrexate therapy: one with and one without preceding diagnostic laparoscopy. Hypothetical tubal patency rates after methotrexate therapy were varied in both scenarios until patients switched in their initial preference. Main Outcome Measure(s): Preference for systemic methotrexate therapy. Result(s): Only a few patients switched in their initial preference when the tubal patency rate after systemic methotrexate therapy was varied. Most preferred methotrexate therapy without an increase in the tubal patency rate in a scenario without preceding diagnostic laparoscopy. A small group never opted for methotrexate therapy even when it would guarantee a 100% tubal patency rate. Conclusion(s): Systemic methotrexate therapy would be preferred by most patients as part of a completely nonsurgical management strategy. Tubal patency was a decisive factor for treatment preference in a minority of patients only.
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randomised trial of systemic methotrexate versus laparoscopic Salpingostomy in tubal pregnancy
The Lancet, 1997Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, Patrick M M Bossuyt, D J Hemrika, F B LammesAbstract:Summary Background Laparoscopic Salpingostomy is a wellestablished treatment for patients with tubal pregnancy who desire to retain fertility. Another approach that preserves the fallopian tube is medical treatment. We compared systemic methotrexate and laparoscopic Salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success, tubal preservation, and homolateral tubal patency. Methods Between January, 1994, and September, 1996, haemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1·0 mg/kg doses of intramuscular methotrexate alternated with 0·1 mg/kg oral folinic acid) or laparoscopic Salpingostomy. Treatment success was defined as complete elimination of the tubal pregnancy (serum human chorionic gonadotropin <2 IU/L) and preservation of the tube. Homolateral tubal patency was assessed by hysterosalpingography. Analysis was by intention to treat. Findings 100 patients were included in the trial. Of 51 patients allocated systemic methotrexate, 42 (82%) were successfully treated with one course; two (4%) patients needed a second course for persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these patients for tubal rupture. Of the 49 patients allocated laparoscopic Salpingostomy, 35 (72%) were successfully treated by laparoscopic Salpingostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast. The tube was preserved in 46 (90%) patients in the methotrexate group versus 45 (92%) in the Salpingostomy group (rate ratio 0·98 [95% CI 0·87–1·1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patients in the methotrexate group and in 23 (59%) of 39 patients in the Salpingostomy group (rate ratio 0·93 [0·64–1·4]).
P J Hajenius - One of the best experts on this subject based on the ideXlab platform.
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treatment of tubal pregnancy in the netherlands an economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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Treatment of tubal pregnancy in The Netherlands: An economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy ☆ ☆☆ ★
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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systemic methotrexate therapy versus laparoscopic Salpingostomy in patients with tubal pregnancy part i impact on patients health related quality of life
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic Salpingostomy for tubal pregnancy. Design: Multicenter randomized clinical trial. Setting: Departments of obstetrics and gynecology of six Dutch hospitals. Patient(s): Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic Salpingostomy. Intervention(s): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks, and 16 weeks after confirmative laparoscopy. Main Outcome Measure(s): Health-related quality of life. Result(s): Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic Salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. Conclusion(s): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic Salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.
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systemic methotrexate therapy versus laparoscopic Salpingostomy in tubal pregnancy part ii patient preferences for systemic methotrexate
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To investigate patient preferences for systemic methotrexate therapy relative to laparoscopic Salpingostomy in the treatment of tubal pregnancy. Design: Preference assessment in controlled clinical study. Setting: Four hospitals and one infertility clinic. Patient(s): Forty patients who had been treated for tubal pregnancy and 40 nonpregnant controls. Intervention(s): Preference for methotrexate therapy relative to Salpingostomy was established during an interview. Two scenarios were offered for methotrexate therapy: one with and one without preceding diagnostic laparoscopy. Hypothetical tubal patency rates after methotrexate therapy were varied in both scenarios until patients switched in their initial preference. Main Outcome Measure(s): Preference for systemic methotrexate therapy. Result(s): Only a few patients switched in their initial preference when the tubal patency rate after systemic methotrexate therapy was varied. Most preferred methotrexate therapy without an increase in the tubal patency rate in a scenario without preceding diagnostic laparoscopy. A small group never opted for methotrexate therapy even when it would guarantee a 100% tubal patency rate. Conclusion(s): Systemic methotrexate therapy would be preferred by most patients as part of a completely nonsurgical management strategy. Tubal patency was a decisive factor for treatment preference in a minority of patients only.
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randomised trial of systemic methotrexate versus laparoscopic Salpingostomy in tubal pregnancy
The Lancet, 1997Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, Patrick M M Bossuyt, D J Hemrika, F B LammesAbstract:Summary Background Laparoscopic Salpingostomy is a wellestablished treatment for patients with tubal pregnancy who desire to retain fertility. Another approach that preserves the fallopian tube is medical treatment. We compared systemic methotrexate and laparoscopic Salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success, tubal preservation, and homolateral tubal patency. Methods Between January, 1994, and September, 1996, haemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1·0 mg/kg doses of intramuscular methotrexate alternated with 0·1 mg/kg oral folinic acid) or laparoscopic Salpingostomy. Treatment success was defined as complete elimination of the tubal pregnancy (serum human chorionic gonadotropin <2 IU/L) and preservation of the tube. Homolateral tubal patency was assessed by hysterosalpingography. Analysis was by intention to treat. Findings 100 patients were included in the trial. Of 51 patients allocated systemic methotrexate, 42 (82%) were successfully treated with one course; two (4%) patients needed a second course for persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these patients for tubal rupture. Of the 49 patients allocated laparoscopic Salpingostomy, 35 (72%) were successfully treated by laparoscopic Salpingostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast. The tube was preserved in 46 (90%) patients in the methotrexate group versus 45 (92%) in the Salpingostomy group (rate ratio 0·98 [95% CI 0·87–1·1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patients in the methotrexate group and in 23 (59%) of 39 patients in the Salpingostomy group (rate ratio 0·93 [0·64–1·4]).
Willem M Ankum - One of the best experts on this subject based on the ideXlab platform.
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treatment of tubal pregnancy in the netherlands an economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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Treatment of tubal pregnancy in The Netherlands: An economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy ☆ ☆☆ ★
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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systemic methotrexate therapy versus laparoscopic Salpingostomy in patients with tubal pregnancy part i impact on patients health related quality of life
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic Salpingostomy for tubal pregnancy. Design: Multicenter randomized clinical trial. Setting: Departments of obstetrics and gynecology of six Dutch hospitals. Patient(s): Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic Salpingostomy. Intervention(s): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks, and 16 weeks after confirmative laparoscopy. Main Outcome Measure(s): Health-related quality of life. Result(s): Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic Salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. Conclusion(s): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic Salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.
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systemic methotrexate therapy versus laparoscopic Salpingostomy in tubal pregnancy part ii patient preferences for systemic methotrexate
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To investigate patient preferences for systemic methotrexate therapy relative to laparoscopic Salpingostomy in the treatment of tubal pregnancy. Design: Preference assessment in controlled clinical study. Setting: Four hospitals and one infertility clinic. Patient(s): Forty patients who had been treated for tubal pregnancy and 40 nonpregnant controls. Intervention(s): Preference for methotrexate therapy relative to Salpingostomy was established during an interview. Two scenarios were offered for methotrexate therapy: one with and one without preceding diagnostic laparoscopy. Hypothetical tubal patency rates after methotrexate therapy were varied in both scenarios until patients switched in their initial preference. Main Outcome Measure(s): Preference for systemic methotrexate therapy. Result(s): Only a few patients switched in their initial preference when the tubal patency rate after systemic methotrexate therapy was varied. Most preferred methotrexate therapy without an increase in the tubal patency rate in a scenario without preceding diagnostic laparoscopy. A small group never opted for methotrexate therapy even when it would guarantee a 100% tubal patency rate. Conclusion(s): Systemic methotrexate therapy would be preferred by most patients as part of a completely nonsurgical management strategy. Tubal patency was a decisive factor for treatment preference in a minority of patients only.
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randomised trial of systemic methotrexate versus laparoscopic Salpingostomy in tubal pregnancy
The Lancet, 1997Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, Patrick M M Bossuyt, D J Hemrika, F B LammesAbstract:Summary Background Laparoscopic Salpingostomy is a wellestablished treatment for patients with tubal pregnancy who desire to retain fertility. Another approach that preserves the fallopian tube is medical treatment. We compared systemic methotrexate and laparoscopic Salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success, tubal preservation, and homolateral tubal patency. Methods Between January, 1994, and September, 1996, haemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1·0 mg/kg doses of intramuscular methotrexate alternated with 0·1 mg/kg oral folinic acid) or laparoscopic Salpingostomy. Treatment success was defined as complete elimination of the tubal pregnancy (serum human chorionic gonadotropin <2 IU/L) and preservation of the tube. Homolateral tubal patency was assessed by hysterosalpingography. Analysis was by intention to treat. Findings 100 patients were included in the trial. Of 51 patients allocated systemic methotrexate, 42 (82%) were successfully treated with one course; two (4%) patients needed a second course for persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these patients for tubal rupture. Of the 49 patients allocated laparoscopic Salpingostomy, 35 (72%) were successfully treated by laparoscopic Salpingostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast. The tube was preserved in 46 (90%) patients in the methotrexate group versus 45 (92%) in the Salpingostomy group (rate ratio 0·98 [95% CI 0·87–1·1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patients in the methotrexate group and in 23 (59%) of 39 patients in the Salpingostomy group (rate ratio 0·93 [0·64–1·4]).
F Van Der Veen - One of the best experts on this subject based on the ideXlab platform.
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treatment of tubal pregnancy in the netherlands an economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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Treatment of tubal pregnancy in The Netherlands: An economic comparison of systemic methotrexate administration and laparoscopic Salpingostomy ☆ ☆☆ ★
American Journal of Obstetrics and Gynecology, 1999Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, D J Hemrika, Patrick M M BossuytAbstract:Abstract Objective: This study was undertaken to compare from a societal perspective the costs of systemic methotrexate administration with those of laparoscopic Salpingostomy for the treatment of patients with tubal pregnancy. Study Design: An economic evaluation was set up in tandem with a multicenter randomized clinical trial that compared systemic methotrexate administration and laparoscopic Salpingostomy for the treatment of 100 hemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy. Data on resources used for treatment and lost production time were prospectively collected and costs of both treatments were calculated by multiplying actual expenses for resource units at a single center and resource unit use measured in all centers. Costs were originally calculated in Dutch guilders and converted to US dollars at a rate of 1.67 guilders/$1. Results: Because clinical outcomes of the trial were equivalent for the 2 strategies a cost-minimization analysis was done. Mean total costs per patient were $5721 for systemic methotrexate administration and $4066 for laparoscopic Salpingostomy, with a mean difference of $1655 (95% confidence interval, $906-$2414). Costs of systemic methotrexate administration were similar to those of Salpingostomy for patients in whom the initial serum human chorionic gonadotropin concentration was 3000 IU/L. Conclusions: Although systemic methotrexate administration is safe and effective for the treatment of tubal pregnancy, it does not necessarily reduce costs. Systemic methotrexate therapy could reduce costs if administered to patients with low initial serum human chorionic gonadotropin concentrations without confirmatory laparoscopy. (Am J Obstet Gynecol 1999;181:945-51.)
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systemic methotrexate therapy versus laparoscopic Salpingostomy in patients with tubal pregnancy part i impact on patients health related quality of life
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic Salpingostomy for tubal pregnancy. Design: Multicenter randomized clinical trial. Setting: Departments of obstetrics and gynecology of six Dutch hospitals. Patient(s): Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic Salpingostomy. Intervention(s): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks, and 16 weeks after confirmative laparoscopy. Main Outcome Measure(s): Health-related quality of life. Result(s): Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic Salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. Conclusion(s): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic Salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.
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systemic methotrexate therapy versus laparoscopic Salpingostomy in tubal pregnancy part ii patient preferences for systemic methotrexate
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To investigate patient preferences for systemic methotrexate therapy relative to laparoscopic Salpingostomy in the treatment of tubal pregnancy. Design: Preference assessment in controlled clinical study. Setting: Four hospitals and one infertility clinic. Patient(s): Forty patients who had been treated for tubal pregnancy and 40 nonpregnant controls. Intervention(s): Preference for methotrexate therapy relative to Salpingostomy was established during an interview. Two scenarios were offered for methotrexate therapy: one with and one without preceding diagnostic laparoscopy. Hypothetical tubal patency rates after methotrexate therapy were varied in both scenarios until patients switched in their initial preference. Main Outcome Measure(s): Preference for systemic methotrexate therapy. Result(s): Only a few patients switched in their initial preference when the tubal patency rate after systemic methotrexate therapy was varied. Most preferred methotrexate therapy without an increase in the tubal patency rate in a scenario without preceding diagnostic laparoscopy. A small group never opted for methotrexate therapy even when it would guarantee a 100% tubal patency rate. Conclusion(s): Systemic methotrexate therapy would be preferred by most patients as part of a completely nonsurgical management strategy. Tubal patency was a decisive factor for treatment preference in a minority of patients only.
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randomised trial of systemic methotrexate versus laparoscopic Salpingostomy in tubal pregnancy
The Lancet, 1997Co-Authors: P J Hajenius, S Engelsbel, F Van Der Veen, Willem M Ankum, Patrick M M Bossuyt, D J Hemrika, F B LammesAbstract:Summary Background Laparoscopic Salpingostomy is a wellestablished treatment for patients with tubal pregnancy who desire to retain fertility. Another approach that preserves the fallopian tube is medical treatment. We compared systemic methotrexate and laparoscopic Salpingostomy in the treatment of tubal pregnancy. Outcome measures were treatment success, tubal preservation, and homolateral tubal patency. Methods Between January, 1994, and September, 1996, haemodynamically stable patients with laparoscopically confirmed unruptured tubal pregnancy and no signs of active bleeding were randomly assigned systemic methotrexate (four 1·0 mg/kg doses of intramuscular methotrexate alternated with 0·1 mg/kg oral folinic acid) or laparoscopic Salpingostomy. Treatment success was defined as complete elimination of the tubal pregnancy (serum human chorionic gonadotropin <2 IU/L) and preservation of the tube. Homolateral tubal patency was assessed by hysterosalpingography. Analysis was by intention to treat. Findings 100 patients were included in the trial. Of 51 patients allocated systemic methotrexate, 42 (82%) were successfully treated with one course; two (4%) patients needed a second course for persistent trophoblast. Surgical intervention was needed in seven (14%) patients; salpingectomy was necessary in five of these patients for tubal rupture. Of the 49 patients allocated laparoscopic Salpingostomy, 35 (72%) were successfully treated by laparoscopic Salpingostomy alone; salpingectomy was needed in four (8%) patients, and ten (20%) needed methotrexate for persistent trophoblast. The tube was preserved in 46 (90%) patients in the methotrexate group versus 45 (92%) in the Salpingostomy group (rate ratio 0·98 [95% CI 0·87–1·1]). Homolateral tubal patency could be assessed in 81 patients: the tube was patent in 23 (55%) of 42 patients in the methotrexate group and in 23 (59%) of 39 patients in the Salpingostomy group (rate ratio 0·93 [0·64–1·4]).
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systemic methotrexate therapy versus laparoscopic Salpingostomy in patients with tubal pregnancy part i impact on patients health related quality of life
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To compare patients' health-related quality of life after systemic methotrexate therapy versus laparoscopic Salpingostomy for tubal pregnancy. Design: Multicenter randomized clinical trial. Setting: Departments of obstetrics and gynecology of six Dutch hospitals. Patient(s): Hemodynamically stable patients with a laparoscopically confirmed unruptured tubal pregnancy without signs of active bleeding, who were randomly assigned to undergo either systemic methotrexate therapy or laparoscopic Salpingostomy. Intervention(s): Standard health-related quality of life questionnaires administered before and 2 days, 2 weeks, 4 weeks, and 16 weeks after confirmative laparoscopy. Main Outcome Measure(s): Health-related quality of life. Result(s): Health-related quality of life was impaired most severely 2 days after confirmative laparoscopy in both treatment groups and improved during follow-up. Health-related quality of life was impaired more severely after systemic methotrexate therapy than after laparoscopic Salpingostomy. Medically treated patients had more limitations in physical functioning, role functioning, and social functioning; had worse health perceptions, less energy, more pain, more physical symptoms, and a worse overall quality of life; and were more depressed than surgically treated patients. Conclusion(s): Systemic methotrexate therapy had a more negative impact on patients' health-related quality of life than did laparoscopic Salpingostomy. This negative impact on patients' health-related quality of life of systemic methotrexate therapy should be taken into account when deciding on the appropriate therapy for tubal pregnancy.
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systemic methotrexate therapy versus laparoscopic Salpingostomy in tubal pregnancy part ii patient preferences for systemic methotrexate
Fertility and Sterility, 1998Co-Authors: Pythia T Nieuwkerk, P J Hajenius, F Van Der Veen, Willem M Ankum, Wouter Wijker, Patrick M M BossuytAbstract:Abstract Objective: To investigate patient preferences for systemic methotrexate therapy relative to laparoscopic Salpingostomy in the treatment of tubal pregnancy. Design: Preference assessment in controlled clinical study. Setting: Four hospitals and one infertility clinic. Patient(s): Forty patients who had been treated for tubal pregnancy and 40 nonpregnant controls. Intervention(s): Preference for methotrexate therapy relative to Salpingostomy was established during an interview. Two scenarios were offered for methotrexate therapy: one with and one without preceding diagnostic laparoscopy. Hypothetical tubal patency rates after methotrexate therapy were varied in both scenarios until patients switched in their initial preference. Main Outcome Measure(s): Preference for systemic methotrexate therapy. Result(s): Only a few patients switched in their initial preference when the tubal patency rate after systemic methotrexate therapy was varied. Most preferred methotrexate therapy without an increase in the tubal patency rate in a scenario without preceding diagnostic laparoscopy. A small group never opted for methotrexate therapy even when it would guarantee a 100% tubal patency rate. Conclusion(s): Systemic methotrexate therapy would be preferred by most patients as part of a completely nonsurgical management strategy. Tubal patency was a decisive factor for treatment preference in a minority of patients only.
