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Annika Strandell - One of the best experts on this subject based on the ideXlab platform.
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cost effectiveness of salpingotomy and Salpingectomy in women with tubal pregnancy a randomized controlled trial
Human Reproduction, 2015Co-Authors: Femke Mol, Harold R. Verhoeve, Annika Strandell, Norah M Van Mello, Jackie Ross, Kurt T Barnhart, Tamer M Yalcinkaya, D Jurkovic, G C M Graziosi, Caroline A M KoksAbstract:STUDY QUESTION: Is salpingotomy cost effective compared with Salpingectomy in women with tubal pregnancy and a healthy contralateral tube? SUMMARY ANSWER: Salpingotomy is not cost effective over Salpingectomy as a surgical procedure for tubal pregnancy, as its costs are higher without a better ongoing pregnancy rate while risks of persistent trophoblast are higher. WHAT IS KNOWN ALREADY: Women with a tubal pregnancy treated by salpingotomy or Salpingectomy in the presence of a healthy contralateral tube have comparable ongoing pregnancy rates by natural conception. Salpingotomy bears the risk of persistent trophoblast necessitating additional medical or surgical treatment. Repeat ectopic pregnancy occurs slightly more often after salpingotomy compared with Salpingectomy. Both consequences imply potentially higher costs after salpingotomy. STUDY DESIGN, SIZE, DURATION: We performed an economic evaluation of salpingotomy compared with Salpingectomy in an international multicentre randomized controlled trial in women with a tubal pregnancy and a healthy contralateral tube. Between 24 September 2004 and 29 November 2011, women were allocated to salpingotomy (n = 215) or Salpingectomy (n = 231). Fertility follow-up was done up to 36 months post-operatively. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: We performed a cost-effectiveness analysis from a hospital perspective. We compared the direct medical costs of salpingotomy and Salpingectomy until an ongoing pregnancy occurred by natural conception within a time horizon of 36 months. Direct medical costs included the surgical treatment of the initial tubal pregnancy, readmissions including reinterventions, treatment for persistent trophoblast and interventions for repeat ectopic pregnancy. The analysis was performed according to the intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE: Mean direct medical costs per woman in the salpingotomy group and in the Salpingectomy group were €3319 versus €2958, respectively, with a mean difference of €361 (95% confidence interval €217 to €515). Salpingotomy resulted in a marginally higher ongoing pregnancy rate by natural conception compared with Salpingectomy leading to an incremental cost-effectiveness ratio €40 982 (95% confidence interval -€130 319 to €145 491) per ongoing pregnancy. Since salpingotomy resulted in more additional treatments for persistent trophoblast and interventions for repeat ectopic pregnancy, the incremental cost-effectiveness ratio was not informative. LIMITATIONS, REASONS FOR CAUTION: Costs of any subsequent IVF cycles were not included in this analysis. The analysis was limited to the perspective of the hospital. WIDER IMPLICATIONS OF THE FINDINGS: However, a small treatment benefit of salpingotomy might be enough to cover the costs of subsequent IVF. This uncertainty should be incorporated in shared decision-making. Whether salpingotomy should be offered depends on society's willingness to pay for an additional child. STUDY FUNDING/COMPETING INTERESTS: Netherlands Organisation for Health Research and Development, Region Vastra Gotaland Health & Medical Care Committee. TRIAL REGISTRATION NUMBER: ISRCTN37002267.
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salpingotomy versus Salpingectomy in women with tubal pregnancy esep study an open label multicentre randomised controlled trial
The Lancet, 2014Co-Authors: Femke Mol, Davor Jurkovic, Annika Strandell, Norah M Van Mello, Karin Strandell, Jackie Ross, Kurt T Barnhart, Tamer M Yalcinkaya, Harold R. VerhoeveAbstract:Summary Background Tubal ectopic pregnancy can be surgically treated by Salpingectomy, in which the affected Fallopian tube is removed, or salpingotomy, in which the tube is preserved. Despite potentially increased risks of persistent trophoblast and repeat ectopic pregnancy, salpingotomy is often preferred over Salpingectomy because the preservation of both tubes is assumed to offer favourable fertility prospects, although little evidence exists to support this assumption. We aimed to assess whether salpingotomy would improve rates of ongoing pregnancy by natural conception compared with Salpingectomy. Methods In this open-label, multicentre, international, randomised controlled trial, women aged 18 years and older with a laparoscopically confirmed tubal pregnancy and a healthy contralateral tube were randomly assigned via a central internet-based randomisation program to receive salpingotomy or Salpingectomy. The primary outcome was ongoing pregnancy by natural conception. Differences in cumulative ongoing pregnancy rates were expressed as a fecundity rate ratio with 95% CI, calculated by Cox proportional-hazards analysis with a time horizon of 36 months. Secondary outcomes were persistent trophoblast and repeat ectopic pregnancy (expressed as relative risks [RRs] with 95% CIs) and ongoing pregnancy after ovulation induction, intrauterine insemination, or IVF. The researchers who collected data for fertility outcomes were masked to the assigned intervention, but patients and the investigators who analysed the data were not. All endpoints were analysed by intention to treat. We also did a (non-prespecified) meta-analysis that included the findings from the present trial. This trial is registered, number ISRCTN37002267. Findings 446 women were randomly assigned between Sept 24, 2004, and Nov 29, 2011, with 215 allocated to salpingotomy and 231 to Salpingectomy. Follow-up was discontinued on Feb 1, 2013. The cumulative ongoing pregnancy rate was 60·7% after salpingotomy and 56·2% after Salpingectomy (fecundity rate ratio 1·06, 95% CI 0·81–1·38; log-rank p=0·678). Persistent trophoblast occurred more frequently in the salpingotomy group than in the Salpingectomy group (14 [7%] vs 1 [ Interpretation In women with a tubal pregnancy and a healthy contralateral tube, salpingotomy does not significantly improve fertility prospects compared with Salpingectomy. Funding Netherlands Organisation for Health Research and Development (ZonMW), Region Vastra Gotaland Health & Medical Care Committee.
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surgical treatment for tubal disease in women due to undergo in vitro fertilisation
Cochrane Database of Systematic Reviews, 2010Co-Authors: Neil P Johnson, Annika Strandell, Sabine F Van Voorst, Martin C Sowter, Ben Willem J MolAbstract:Background Tubal disease accounts for 20% of infertility cases. Hydrosalpinx, caused by distal tubal occlusion leading to fluid accumulation in the tube(s), is a particularly severe form of tubal disease negatively affecting the outcomes of assisted reproductive technology (ART). It is thought that tubal surgery may improve the outcome of ART in women with hydrosalpinges. Objectives To assess the effectiveness and safety of tubal surgery in women with hydrosalpinges prior to undergoing conventional in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Search methods We searched the Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL, DARE, and two trial registers on 8 January 2020, together with reference checking and contact with study authors and experts in the field to identify additional trials. Selection criteria Randomised controlled trials (RCTs) comparing surgical treatment versus no surgical treatment, or comparing surgical interventions head-to-head, in women with tubal disease prior to undergoing IVF. Data collection and analysis We used Cochrane's standard methodological procedures. The primary outcomes were live birth rate (LBR) and surgical complication rate per woman randomised. Secondary outcomes included clinical, multiple and ectopic pregnancy rates, miscarriage rates and mean numbers of oocytes retrieved and of embryos obtained. Main results We included 11 parallel-design RCTs, involving a total of 1386 participants. The included trials compared different types of tubal surgery (Salpingectomy, tubal occlusion or transvaginal aspiration of hydrosalpingeal fluid) to no tubal surgery, or individual interventions to one another. We assessed no studies as being at low risk of bias across all domains, with the main limitations being lack of blinding, wide confidence intervals and low event and sample sizes. We used GRADE methodology to rate the quality of the evidence. Apart from one moderate-quality result in one review comparison, the evidence provided by these 11 trials ranged between very low- to low-quality. Salpingectomy versus no tubal surgery No included study reported on LBR for this comparison. We are uncertain of the effect of Salpingectomy on surgical complications such as the rate of conversion to laparotomy (Peto odds ratio (OR) 5.80, 95% confidence interval (CI) 0.11 to 303.69; one RCT; n = 204; very low-quality evidence) and pelvic infection (Peto OR 5.80, 95% CI 0.11 to 303.69; one RCT; n = 204; very low-quality evidence). Salpingectomy probably increases clinical pregnancy rate (CPR) versus no surgery (risk ratio (RR) 2.02, 95% CI 1.44 to 2.82; four RCTs; n = 455; I2 = 42.5%; moderate-quality evidence). This suggests that in women with a CPR of approximately 19% without tubal surgery, the rate with Salpingectomy lies between 27% and 52%. Proximal tubal occlusion versus no surgery No study reported on LBR and surgical complication rate for this comparison. Tubal occlusion may increase CPR compared to no tubal surgery (RR 3.21, 95% CI 1.72 to 5.99; two RCTs; n = 209; I2 = 0%; low-quality evidence). This suggests that with a CPR of approximately 12% without tubal surgery, the rate with tubal occlusion lies between 21% and 74%. Transvaginal aspiration of hydrosalpingeal fluid versus no surgery No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 176). We are uncertain whether transvaginal aspiration of hydrosalpingeal fluid increases CPR compared to no tubal surgery (RR 1.67, 95% CI 1.10 to 2.55; three RCTs; n = 311; I2 = 0%; very low-quality evidence). Laparoscopic proximal tubal occlusion versus laparoscopic Salpingectomy We are uncertain of the effect of laparoscopic proximal tubal occlusion versus laparoscopic Salpingectomy on LBR (RR 1.21, 95% CI 0.76 to 1.95; one RCT; n = 165; very low-quality evidence) and CPR (RR 0.81, 95% CI 0.62 to 1.07; three RCTs; n = 347; I2 = 77%; very low-quality evidence). No study reported on surgical complication rate for this comparison. Transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic Salpingectomy No study reported on LBR for this comparison, and there was insufficient evidence to identify a difference in surgical complication rate between groups (Peto OR not estimable; one RCT; n = 160). We are uncertain of the effect of transvaginal aspiration of hydrosalpingeal fluid versus laparoscopic Salpingectomy on CPR (RR 0.69, 95% CI 0.44 to 1.07; one RCT; n = 160; very low-quality evidence). Authors' conclusions We found moderate-quality evidence that Salpingectomy prior to ART probably increases the CPR compared to no surgery in women with hydrosalpinges. When comparing tubal occlusion to no intervention, we found that tubal occlusion may increase CPR, although the evidence was of low quality. We found insufficient evidence of any effect on procedure- or pregnancy-related adverse events when comparing tubal surgery to no intervention. Importantly, none of the studies reported on long term fertility outcomes. Further high-quality trials are required to definitely determine the impact of tubal surgery on IVF and pregnancy outcomes of women with hydrosalpinges, particularly for LBR and surgical complications; and to investigate the relative efficacy and safety of the different surgical modalities in the treatment of hydrosalpinges prior to ART.
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the esep study salpingostomy versus Salpingectomy for tubal ectopic pregnancy the impact on future fertility a randomised controlled trial
BMC Women's Health, 2008Co-Authors: Annika Strandell, Tamer Yalcinkaya, Andreas L Thurkow, Giuseppe C. M. Graziosi, Harold R. Verhoeve, Paul J.q. Van Der Linden, Annemieke Hoek, Caroline A M Koks, Davor Jurkovic, Lars HogströmAbstract:For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy) or radically (Salpingectomy) in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to Salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP. International multi centre randomised controlled trial comparing salpingostomy versus Salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF) and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and Salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation. The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision analysis framework, based on costs per live birth, including IVF treatment whenever a spontaneous pregnancy does not occur. Patients' preferences will be assessed using a discrete choice experiment. This trial will provide evidence on the trade off between salpingostomy and Salpingectomy for tubal EP in view of the pros and cons of both interventions and will offer guidance to clinicians in making the right treatment choice. Current Controlled Trials ISRCTN37002267
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hydrosalpinx and ivf outcome cumulative results after Salpingectomy in a randomized controlled trial
Human Reproduction, 2001Co-Authors: Annika Strandell, Anette Lindhard, Ulla Waldenstrom, Jane ThorburnAbstract:BACKGROUND: A randomized controlled trial of Salpingectomy prior to IVF in patients with hydrosalpinges has been conducted in Scandinavia. The results from the first transfer cycle have been published and clearly demonstrated an improved pregnancy outcome after Salpingectomy had been performed in patients with hydrosalpinges large enough to be visible on ultrasound. The present article is aimed at analysing the effect of Salpingectomy on cumulative birth rate, including all individual transfer cycles. METHODS AND RESULTS: A total of 186 women underwent 452 cycles. Among the 77 women randomized to no surgical intervention, 24 underwent Salpingectomy after one or two failed cycles. Cumulative results were analysed by Cox regression, taking into account the number of cycles per patient and the presence of a Salpingectomy after a previous transfer. Salpingectomy implied a significant increase in birth rate (hazard ratio 2.1, 95% CI 1.6-3.6, P = 0.014). Within the subgroup of patients with ultrasound-visible hydrosalpinges, the birth rate was even higher (hazard ratio 3.8, 95% CI 1.5-9.2, P = 0.004). Implantation rate was significantly higher in patients who had undergone Salpingectomy (27.2% versus 20.2, P = 0.03) and, in the subgroup of patients with ultrasound-visible hydrosalpinges, the difference was even larger (30.3% versus 17.1%, P = 0.003). CONCLUSIONS: The results of the cumulative cycles strengthen the recommendation for a laparoscopic Salpingectomy prior to IVF in patients with ultrasound-visible hydrosalpinges.
Warner K Huh - One of the best experts on this subject based on the ideXlab platform.
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the cost effectiveness of opportunistic Salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction
Gynecologic Oncology, 2019Co-Authors: Akila Subramaniam, Brett D Einerson, Christina T Blanchard, Britt K Erickson, Jeff M Szychowski, Charles A Leath, Joseph R Biggio, Warner K HuhAbstract:Abstract Objectives Opportunistic Salpingectomy is a cost-effective strategy recommended for ovarian cancer (OvCa) risk reduction at the time of gynecologic surgery in women who have completed childbearing. We aimed to evaluate the cost-effectiveness of opportunistic Salpingectomy compared to standard tubal ligation (TL) during cesarean delivery. Study design A cost-effectiveness analysis using decision modeling to compare opportunistic Salpingectomy to TL at the time of cesarean using probabilities of procedure completion derived from a trial. Probability and cost inputs were derived from local data and the literature. The primary outcome was the incremental cost-effectiveness ratio (ICER) in 2017 U.S. dollars per quality-adjusted life year (QALY) at a cost-effectiveness threshold of $100,000/QALY. One- and two-way sensitivity analyses were performed for all variables. A probabilistic sensitivity analysis determined the proportion of simulations in which each strategy would be cost-effective. Results Opportunistic Salpingectomy was cost-effective compared to TL with an ICER of $26,616 per QALY. In 10,000 women desiring sterilization with cesarean, opportunistic Salpingectomy would result in 17 fewer OvCa diagnoses, 13 fewer OvCa deaths, and 25 fewer unintended pregnancies compared to TL – with an associated cost increase of $4.7 million. The model was sensitive only to OvCa risk reduction from Salpingectomy and TL. Opportunistic Salpingectomy was not cost-effective if its cost was >$3163.74 more than TL, if the risk-reduction of Salpingectomy was 46%. In probabilistic sensitivity analysis opportunistic Salpingectomy was cost effective in 75% of simulations. Conclusions In women undergoing cesarean with sterilization, opportunistic Salpingectomy is likely cost-effective and may be cost-saving in comparison to TL for OvCa risk reduction.
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feasibility of complete Salpingectomy compared with standard postpartum tubal ligation at cesarean delivery a randomized controlled trial
Obstetrics & Gynecology, 2018Co-Authors: Akila Subramaniam, Christina T Blanchard, Britt K Erickson, Jeff M Szychowski, Charles A Leath, Joseph R Biggio, Warner K HuhAbstract:OBJECTIVE To evaluate the feasibility of Salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility. METHODS We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral Salpingectomy or bilateral tubal ligation by a computer-generated scheme. If Salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided α of 0.05. Analysis was by intent to treat. RESULTS Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized-40 to Salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the Salpingectomy group (median 10 [interquartile range 5-25] compared with 5 [interquartile range 5-10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups. CONCLUSION Adding 15 minutes to total operative times, Salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov, NCT02374827.
Jurgen M J Piek - One of the best experts on this subject based on the ideXlab platform.
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hysterectomy with opportunistic Salpingectomy versus hysterectomy alone
Cochrane Database of Systematic Reviews, 2019Co-Authors: L A M Van Lieshout, Saskia Houterman, J.a. De ,hullu, Miranda P Steenbeek, Caroline M Vos, Jack Wilkinson, Jurgen M J PiekAbstract:Background Ovarian cancer has the highest mortality rate of all gynaecological malignancies with an overall five-year survival rate of 30% to 40%. In the past two decades it has become apparent and more commonly accepted that a majority of ovarian cancers originate in the fallopian tube epithelium and not from the ovary itself. This paradigm shift introduced new possibilities for ovarian cancer prevention. Salpingectomy during a hysterectomy for benign gynaecological indications (also known as opportunistic Salpingectomy) might reduce the overall incidence of ovarian cancer. Aside from efficacy, safety is of utmost importance, especially due to the preventive nature of opportunistic Salpingectomy. Most important are safety in the form of surgical adverse events and postoperative hormonal status. Therefore, we compared the benefits and risks of hysterectomy with opportunistic Salpingectomy to hysterectomy without opportunistic Salpingectomy. Objectives To assess the effect and safety of hysterectomy with opportunistic Salpingectomy versus hysterectomy without Salpingectomy for ovarian cancer prevention in women undergoing hysterectomy for benign gynaecological indications; outcomes of interest include the incidence of epithelial ovarian cancer, surgery-related adverse events and postoperative ovarian reserve. Search methods The Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two clinical trial registers were searched in January 2019 together with reference checking and contact with study authors. Selection criteria We intended to include both randomised controlled trials (RCTs) and non-RCTs that compared ovarian cancer incidence after hysterectomy with opportunistic Salpingectomy to hysterectomy without opportunistic Salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For assessment of surgical and hormonal safety, we included RCTs that compared hysterectomy with opportunistic Salpingectomy to hysterectomy without opportunistic Salpingectomy in women undergoing hysterectomy for benign gynaecological indications. Data collection and analysis We used standard methodological procedures recommended by Cochrane. The primary review outcomes were ovarian cancer incidence, intraoperative and short-term postoperative complication rate and postoperative hormonal status. Secondary outcomes were total surgical time, estimated blood loss, conversion rate to open surgery (applicable only to laparoscopic and vaginal approaches), duration of hospital admission, menopause-related symptoms and quality of life. Main results We included seven RCTs (350 women analysed). The evidence was of very low to low quality: the main limitations being a low number of included women and surgery-related adverse events, substantial loss to follow-up and a large variety in outcome measures and timing of measurements.No studies reported ovarian cancer incidence after hysterectomy with opportunistic Salpingectomy compared to hysterectomy without opportunistic Salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For surgery-related adverse events, there were insufficient data to assess whether there was any difference in both intraoperative (odds ratio (OR) 0.66, 95% confidence interval (CI) 0.11 to 3.94; 5 studies, 286 participants; very low-quality evidence) and short-term postoperative (OR 0.13, 95% CI 0.01 to 2.14; 3 studies, 152 participants; very low-quality evidence) complication rates between hysterectomy with opportunistic Salpingectomy and hysterectomy without opportunistic Salpingectomy because the number of surgery-related adverse events was very low. For postoperative hormonal status, the results were compatible with no difference, or with a reduction in anti-Mullerian hormone (AMH) that would not be clinically relevant (mean difference (MD) -0.94, 95% CI -1.89 to 0.01; I2 = 0%; 5 studies, 283 participants; low-quality evidence). A reduction in AMH would be unfavourable, but due to wide CIs, the postoperative change in AMH can still vary from a substantial decrease to even a slight increase. Authors' conclusions There were no eligible studies reporting on one of our primary outcomes - the incidence of ovarian cancer specifically after hysterectomy with or without opportunistic Salpingectomy. However, outside the scope of this review there is a growing body of evidence for the effectiveness of opportunistic Salpingectomy itself during other interventions or as a sterilisation technique, strongly suggesting a protective effect. In our meta-analyses, we found insufficient data to assess whether there was any difference in surgical adverse events, with a very low number of events in women undergoing hysterectomy with and without opportunistic Salpingectomy. For postoperative hormonal status we found no evidence of a difference between the groups. The maximum difference in time to menopause, calculated from the lower limit of the 95% CI and the natural average AMH decline, would be approximately 20 months, which we consider to be not clinically relevant. However, the results should be interpreted with caution and even more so in very young women for whom a difference in postoperative hormonal status is potentially more clinically relevant. Therefore, there is a need for research on the long-term effects of opportunistic Salpingectomy during hysterectomy, particularly in younger women, as results are currently limited to six months postoperatively. This limit is especially important as AMH, the most frequently used marker for ovarian reserve, recovers over the course of several months following an initial sharp decline after surgery. In light of the available evidence, addition of opportunistic Salpingectomy should be discussed with each woman undergoing a hysterectomy for benign indication, with provision of a clear overview of benefits and risks.
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opportunistic Salpingectomy in women undergoing hysterectomy results from the hystub randomised controlled trial
Maturitas, 2018Co-Authors: L A M Van Lieshout, Brenda M Pijlman, M C Vos, M J M De Groot, Saskia Houterman, S F P J Coppus, Marline G Harmsen, Ingrid Vandenput, Jurgen M J PiekAbstract:Abstract Objective To evaluate whether opportunistic Salpingectomy in premenopausal women undergoing hysterectomy for benign indications is both hormonally and surgically safe, compared with hysterectomy without Salpingectomy. Study design In this multicentre randomised controlled trial, women were randomised to undergo either hysterectomy with opportunistic bilateral Salpingectomy (intervention group) or standard hysterectomy with preservation of the Fallopian tubes (control group). Main outcome measures The primary outcome was the difference in serum anti-Mullerian hormone concentration (ΔAMH), measured pre-surgery and 6 months post-surgery. Secondary outcomes were surgical outcomes and duration of hospital stay. The sample size was powered at 50 participants per group (n = 100) to compare ΔAMH after hysterectomy with Salpingectomy to ΔAMH after standard hysterectomy. Results Between March 2013 and December 2016, 104 women, aged 30–55 years, were randomly allocated to hysterectomy with opportunistic bilateral Salpingectomy (n = 52) or standard hysterectomy (n = 52). The baseline characteristics did not differ between the two groups. The median ΔAMH was −0.14 pmol/L (IQR −1.47–0.95) in the intervention group and 0.00 pmol/L (IQR −1.05–0.80) in the control group (p = 0.49). The addition of Salpingectomy did not impair surgical results and it did not affect duration of hospital stay. Conclusion Addition of opportunistic bilateral Salpingectomy during hysterectomy did not result in a larger effect on ovarian reserve when compared with hysterectomy alone, neither did it affect surgical outcomes. Therefore, opportunistic Salpingectomy seems to be a safe procedure in premenopausal women undergoing hysterectomy for benign gynaecological conditions.
Akila Subramaniam - One of the best experts on this subject based on the ideXlab platform.
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the cost effectiveness of opportunistic Salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction
Gynecologic Oncology, 2019Co-Authors: Akila Subramaniam, Brett D Einerson, Christina T Blanchard, Britt K Erickson, Jeff M Szychowski, Charles A Leath, Joseph R Biggio, Warner K HuhAbstract:Abstract Objectives Opportunistic Salpingectomy is a cost-effective strategy recommended for ovarian cancer (OvCa) risk reduction at the time of gynecologic surgery in women who have completed childbearing. We aimed to evaluate the cost-effectiveness of opportunistic Salpingectomy compared to standard tubal ligation (TL) during cesarean delivery. Study design A cost-effectiveness analysis using decision modeling to compare opportunistic Salpingectomy to TL at the time of cesarean using probabilities of procedure completion derived from a trial. Probability and cost inputs were derived from local data and the literature. The primary outcome was the incremental cost-effectiveness ratio (ICER) in 2017 U.S. dollars per quality-adjusted life year (QALY) at a cost-effectiveness threshold of $100,000/QALY. One- and two-way sensitivity analyses were performed for all variables. A probabilistic sensitivity analysis determined the proportion of simulations in which each strategy would be cost-effective. Results Opportunistic Salpingectomy was cost-effective compared to TL with an ICER of $26,616 per QALY. In 10,000 women desiring sterilization with cesarean, opportunistic Salpingectomy would result in 17 fewer OvCa diagnoses, 13 fewer OvCa deaths, and 25 fewer unintended pregnancies compared to TL – with an associated cost increase of $4.7 million. The model was sensitive only to OvCa risk reduction from Salpingectomy and TL. Opportunistic Salpingectomy was not cost-effective if its cost was >$3163.74 more than TL, if the risk-reduction of Salpingectomy was 46%. In probabilistic sensitivity analysis opportunistic Salpingectomy was cost effective in 75% of simulations. Conclusions In women undergoing cesarean with sterilization, opportunistic Salpingectomy is likely cost-effective and may be cost-saving in comparison to TL for OvCa risk reduction.
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feasibility of complete Salpingectomy compared with standard postpartum tubal ligation at cesarean delivery a randomized controlled trial
Obstetrics & Gynecology, 2018Co-Authors: Akila Subramaniam, Christina T Blanchard, Britt K Erickson, Jeff M Szychowski, Charles A Leath, Joseph R Biggio, Warner K HuhAbstract:OBJECTIVE To evaluate the feasibility of Salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility. METHODS We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral Salpingectomy or bilateral tubal ligation by a computer-generated scheme. If Salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided α of 0.05. Analysis was by intent to treat. RESULTS Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized-40 to Salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the Salpingectomy group (median 10 [interquartile range 5-25] compared with 5 [interquartile range 5-10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups. CONCLUSION Adding 15 minutes to total operative times, Salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov, NCT02374827.
Caroline A M Koks - One of the best experts on this subject based on the ideXlab platform.
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cost effectiveness of salpingotomy and Salpingectomy in women with tubal pregnancy a randomized controlled trial
Human Reproduction, 2015Co-Authors: Femke Mol, Harold R. Verhoeve, Annika Strandell, Norah M Van Mello, Jackie Ross, Kurt T Barnhart, Tamer M Yalcinkaya, D Jurkovic, G C M Graziosi, Caroline A M KoksAbstract:STUDY QUESTION: Is salpingotomy cost effective compared with Salpingectomy in women with tubal pregnancy and a healthy contralateral tube? SUMMARY ANSWER: Salpingotomy is not cost effective over Salpingectomy as a surgical procedure for tubal pregnancy, as its costs are higher without a better ongoing pregnancy rate while risks of persistent trophoblast are higher. WHAT IS KNOWN ALREADY: Women with a tubal pregnancy treated by salpingotomy or Salpingectomy in the presence of a healthy contralateral tube have comparable ongoing pregnancy rates by natural conception. Salpingotomy bears the risk of persistent trophoblast necessitating additional medical or surgical treatment. Repeat ectopic pregnancy occurs slightly more often after salpingotomy compared with Salpingectomy. Both consequences imply potentially higher costs after salpingotomy. STUDY DESIGN, SIZE, DURATION: We performed an economic evaluation of salpingotomy compared with Salpingectomy in an international multicentre randomized controlled trial in women with a tubal pregnancy and a healthy contralateral tube. Between 24 September 2004 and 29 November 2011, women were allocated to salpingotomy (n = 215) or Salpingectomy (n = 231). Fertility follow-up was done up to 36 months post-operatively. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: We performed a cost-effectiveness analysis from a hospital perspective. We compared the direct medical costs of salpingotomy and Salpingectomy until an ongoing pregnancy occurred by natural conception within a time horizon of 36 months. Direct medical costs included the surgical treatment of the initial tubal pregnancy, readmissions including reinterventions, treatment for persistent trophoblast and interventions for repeat ectopic pregnancy. The analysis was performed according to the intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE: Mean direct medical costs per woman in the salpingotomy group and in the Salpingectomy group were €3319 versus €2958, respectively, with a mean difference of €361 (95% confidence interval €217 to €515). Salpingotomy resulted in a marginally higher ongoing pregnancy rate by natural conception compared with Salpingectomy leading to an incremental cost-effectiveness ratio €40 982 (95% confidence interval -€130 319 to €145 491) per ongoing pregnancy. Since salpingotomy resulted in more additional treatments for persistent trophoblast and interventions for repeat ectopic pregnancy, the incremental cost-effectiveness ratio was not informative. LIMITATIONS, REASONS FOR CAUTION: Costs of any subsequent IVF cycles were not included in this analysis. The analysis was limited to the perspective of the hospital. WIDER IMPLICATIONS OF THE FINDINGS: However, a small treatment benefit of salpingotomy might be enough to cover the costs of subsequent IVF. This uncertainty should be incorporated in shared decision-making. Whether salpingotomy should be offered depends on society's willingness to pay for an additional child. STUDY FUNDING/COMPETING INTERESTS: Netherlands Organisation for Health Research and Development, Region Vastra Gotaland Health & Medical Care Committee. TRIAL REGISTRATION NUMBER: ISRCTN37002267.
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the esep study salpingostomy versus Salpingectomy for tubal ectopic pregnancy the impact on future fertility a randomised controlled trial
BMC Women's Health, 2008Co-Authors: Annika Strandell, Tamer Yalcinkaya, Andreas L Thurkow, Giuseppe C. M. Graziosi, Harold R. Verhoeve, Paul J.q. Van Der Linden, Annemieke Hoek, Caroline A M Koks, Davor Jurkovic, Lars HogströmAbstract:For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy) or radically (Salpingectomy) in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to Salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP. International multi centre randomised controlled trial comparing salpingostomy versus Salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF) and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and Salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation. The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision analysis framework, based on costs per live birth, including IVF treatment whenever a spontaneous pregnancy does not occur. Patients' preferences will be assessed using a discrete choice experiment. This trial will provide evidence on the trade off between salpingostomy and Salpingectomy for tubal EP in view of the pros and cons of both interventions and will offer guidance to clinicians in making the right treatment choice. Current Controlled Trials ISRCTN37002267
