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Marlies Y Bongers - One of the best experts on this subject based on the ideXlab platform.
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laparoscopic Sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse a randomized controlled trial salto 2 trial study protocol
BMC Women's Health, 2017Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Ben Willem J Mol, J. Veen, Melanie N Van Ijsselmuiden, Jan Paul W R Roovers, Marlies Y BongersAbstract:Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal Sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic Sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy as the treatment of vaginal vault prolapse. We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic Sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic Sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.
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Laparoscopic Sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol
BMC Women's Health, 2017Co-Authors: Annelotte W M Coolen, Ben Willem J Mol, Mèlanie N. Ijsselmuiden, Anique M. J. Oudheusden, J. Veen, Hugo W. F. Eijndhoven, Jan Paul Roovers, Marlies Y BongersAbstract:Background Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal Sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic Sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy as the treatment of vaginal vault prolapse. Methods We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic Sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. Discussion The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic Sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Trial registration Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.
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laparoscopic Sacrocolpopexy compared with open abdominal Sacrocolpopexy for vault prolapse repair a randomised controlled trial
International Urogynecology Journal, 2017Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Ben Willem J Mol, Jan Paul W R Roovers, Marlies Y BongersAbstract:The objective was to evaluate the functional outcome after laparoscopic Sacrocolpopexy versus open Sacrocolpopexy in women with vault prolapse. A multicentre randomised controlled trial was carried out at four teaching and two university hospitals in the Netherlands in women with symptomatic vault prolapse requiring surgical treatment. Participants were randomised for laparoscopic or open Sacrocolpopexy. Primary outcome was disease-specific quality of life measured using the Urinary Distress Inventory (UDI) questionnaire at 12 months’ follow-up. Secondary outcomes included anatomical outcome and perioperative data. We needed 74 participants to show a difference of 10 points on the prolapse domain of the UDI 12 months after surgery (power of 80%, α error 0.05). Between 2007 and 2012, a total of 74 women were randomised. Follow-up after 12 months showed no significant differences in domain scores of the UDI between the two groups. After 12 months, both groups reported a UDI score of 0.0 (IQR: 0–0) for the domain “genital prolapse”, which was the primary outcome. There were no significant differences between the two groups (p = 0.93). The number of severe complications was 4 in the laparoscopic group versus 7 in the open abdominal group (RR 0.57; 95% CI 0.50–2.27). There was less blood loss and a shorter hospital stay after laparoscopy; 2 (IQR 2–3) versus 4 (IQR 3–5) days, which was statistically different. There was no significant difference in anatomical outcome at 12 months. Our trial provides evidence to support a laparoscopic approach when performing Sacrocolpopexy, as there was less blood loss and hospital stay was shorter, whereas functional and anatomical outcome were not statistically different.
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a comparison of complications between open abdominal Sacrocolpopexy and laparoscopic Sacrocolpopexy for the treatment of vault prolapse
Obstetrics and Gynecology International, 2013Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Tim P F M Van Der Heijden, Rutger A Stokmans, Ben Willem J Mol, Marlies Y BongersAbstract:Introduction. Sacrocolpopexy is a generally applied treatment for vault prolapse which can be performed laparoscopically or by open laparotomy. Methods. Between October 2007 and December 2012, we performed a multicenter prospective cohort study in 2 university and 4 teaching hospitals in the Netherlands. We included patients with symptomatic posthysterectomy vaginal vault prolapse requiring surgical treatment, who either had abdominal or laparoscopic Sacrocolpopexy. We studied surgery related morbidity, which was divided in pre-, peri-, and postoperative characteristics. Results. We studied 85 patients, of whom 42 had open abdominal and 43 laparoscopic Sacrocolpopexy. In the laparoscopic Sacrocolpopexy group, estimated blood loss was significantly less compared to the abdominal group: 192 mL (±126) versus 77 mL (±182), respectively (P ≤ .001). Furthermore, hospital stay was significantly shorter in the laparoscopic group (4.2 days) as compared to the abdominal group (2.4 days) (P ≤ .001). The overall complication rate was not significantly different (P = .121). However there was a significant difference in favor of the laparoscopic group in peri- and postoperative complications requiring complementary (conservative) treatment and/or extended admittance (RR 0.24 (95%-CI 0.07-0.80), P = .009). Conclusion. Laparoscopic Sacrocolpopexy reduces blood loss and hospital stay as compared to abdominal Sacrocolpopexy and generates less procedure related morbidity.
Anthony G. Visco - One of the best experts on this subject based on the ideXlab platform.
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does mesh weight affect time to failure after robotic assisted laparoscopic Sacrocolpopexy
Female pelvic medicine & reconstructive surgery, 2020Co-Authors: Amy L Askew, Nazema Y. Siddiqui, Anthony G. Visco, Alison C Weidner, Tracy Truong, Megan S BradleyAbstract:Objective The objective of this study was to compare time to anatomic failure after robotic Sacrocolpopexy with use of ultralightweight versus heavier weight mesh types. Methods We performed a retrospective cohort study of women who underwent robotic Sacrocolpopexy, from January 2012 to September 2016. We compared (1) Sacrocolpopexy with ultralightweight mesh (≤20 g/m) versus (2) Sacrocolpopexy with heavier weight mesh (≤35 g/m). Our primary outcome was time to anatomic failure, defined as recurrent prolapse beyond the hymen, or retreatment for prolapse with surgery or pessary. Secondary outcomes were compartment of failure and mesh exposure. Cox proportional hazards modeling was used to estimate the hazard of failure based on mesh type. Results Of 461 patients, 248 (53.8%) underwent Sacrocolpopexy with ultralightweight mesh and 213 (46.2%) with heavier weight mesh. Failures occurred in 37 women, with 21 in the ultralightweight mesh group and 16 in the heavier weight mesh group. Time to failure was statistically significant between groups (P = 0.03). Ultralightweight mesh had twice the hazard of failure within 3 years compared with heavier weight mesh (hazard ratio, 2.15; 95% confidence interval, 1.10-4.21; P = 0.03). Among failures, use of ultralightweight mesh was associated with almost 5 times the hazard of anterior compartment failure (hazard ratio, 4.46; 95% confidence interval, 1.39-14.27; P = 0.01). There was no difference in time to posterior failure. Of 17 mesh exposures, there were fewer in the ultralightweight mesh group, although this group was followed for less time (1.6% ultralightweight vs 6.0% heavier weight, P = 0.01). Conclusions Women receiving ultralightweight mesh are more likely to experience earlier anatomic failure in the anterior compartment.
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robotic assisted Sacrocolpopexy early postoperative outcomes after surgical reduction of enlarged genital hiatus
Obstetrical & Gynecological Survey, 2018Co-Authors: Megan S Bradley, Amy L Askew, Monique H Vaughan, Amie Kawasaki, Anthony G. ViscoAbstract:(Abstracted from Am J Obstet Gynecol 2018;218:514.e1–514.e8)Robotic-assisted Sacrocolpopexy (RSC) has comparable surgical outcomes and less perioperative morbidity than abdominal Sacrocolpopexy.
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robotic assisted Sacrocolpopexy early postoperative outcomes after surgical reduction of enlarged genital hiatus
American Journal of Obstetrics and Gynecology, 2018Co-Authors: Megan S Bradley, Amy L Askew, Monique H Vaughan, Amie Kawasaki, Anthony G. ViscoAbstract:Background Currently, the decision to perform a concurrent posterior repair/perineoplasty at the time of robotic-assisted Sacrocolpopexy is not standardized. Objective We sought to compare anatomic failure after robotic-assisted Sacrocolpopexy among 3 groups of patients categorized by their preoperative and postoperative genital hiatus size. Study Design We performed a retrospective cohort study of women who underwent robotic-assisted Sacrocolpopexy, from January 2013 through September 2016. We defined a wide genital hiatus as ≥4 cm and a normal genital hiatus as Results Our study population consisted of 452 women with a mean age of 59.3 ± 10.0 years and a mean body mass index of 27.8 ± 5.3 kg/m2. Of the women with reported race, 394/447 (88.1%) were white. The genital hiatus groups were distributed as follows: 57 (12.6%) were persistently wide, 296 (65.5%) were improved, and 99 (21.9%) were stably normal. The stably normal group had less advanced preoperative prolapse (stage ≥3) than the other groups (P Conclusion Surgical reduction of an enlarged preoperative genital hiatus decreases early composite anatomic failure, after robotic Sacrocolpopexy, specifically related to the posterior compartment. Studies investigating the correlation of intraoperative measurement of genital hiatus to postoperative genital hiatus are needed to help clinicians determine who may benefit from a concomitant posterior repair/perineoplasty at the time of robotic-assisted Sacrocolpopexy.
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long term outcomes following abdominal Sacrocolpopexy for pelvic organ prolapse
JAMA, 2013Co-Authors: Ingrid Nygaard, Paul Fine, Linda Brubaker, Geoffrey W. Cundiff, Holly E. Richter, Halina M. Zyczynski, Shawn A Menefee, Beri Ridgeway, Marie G Gantz, Anthony G. ViscoAbstract:Importance More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal Sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness. Objectives To describe anatomic and symptomatic outcomes up to 7 years after abdominal Sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy). Design, Setting, and Participants Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal Sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years. Main Outcomes and Measures Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index. Results By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, 0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, 0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, 0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of 0.153; 95% CI, 0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of 0.064; 95% CI, 0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). Conclusions and Relevance During 7 years of follow-up, abdominal Sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal Sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. Trial Registration clinicaltrials.gov Identifier: NCT00099372
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symptomatic and anatomic 1 year outcomes after robotic and abdominal Sacrocolpopexy
American Journal of Obstetrics and Gynecology, 2012Co-Authors: Nazema Y. Siddiqui, Elizabeth J. Geller, Anthony G. ViscoAbstract:Objective The purpose of this study was to compare symptomatic and anatomic outcomes 1 year after robotic vs abdominal Sacrocolpopexy. Study design Our retrospective cohort study compared women who underwent robotic Sacrocolpopexy (RSC) with 1 surgeon to those who underwent abdominal Sacrocolpopexy (ASC) as part of the Colpopexy and Urinary Reduction Efforts trial. Our primary outcome was a composite measure of vaginal bulge symptoms or repeat surgery for prolapse. Results We studied 447 women (125 with RSC and 322 with ASC). Baseline characteristics were similar. There were no significant differences in surgical failures 1 year after surgery based on our primary composite outcome (7/86 [8%] vs 12/304 [4%]; P = .16). When we considered anatomic failure, there were also no significant differences between RSC and ASC (4/70 [6%] vs 16/289 [6%]; P = .57). Conclusion One year after Sacrocolpopexy, women who underwent RSC have similar symptomatic and anatomic success compared with those women who underwent ASC.
Annelotte W M Coolen - One of the best experts on this subject based on the ideXlab platform.
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laparoscopic Sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse a randomized controlled trial salto 2 trial study protocol
BMC Women's Health, 2017Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Ben Willem J Mol, J. Veen, Melanie N Van Ijsselmuiden, Jan Paul W R Roovers, Marlies Y BongersAbstract:Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal Sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic Sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy as the treatment of vaginal vault prolapse. We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic Sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic Sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.
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Laparoscopic Sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol
BMC Women's Health, 2017Co-Authors: Annelotte W M Coolen, Ben Willem J Mol, Mèlanie N. Ijsselmuiden, Anique M. J. Oudheusden, J. Veen, Hugo W. F. Eijndhoven, Jan Paul Roovers, Marlies Y BongersAbstract:Background Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal Sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic Sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy as the treatment of vaginal vault prolapse. Methods We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic Sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. Discussion The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic Sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Trial registration Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.
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laparoscopic Sacrocolpopexy compared with open abdominal Sacrocolpopexy for vault prolapse repair a randomised controlled trial
International Urogynecology Journal, 2017Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Ben Willem J Mol, Jan Paul W R Roovers, Marlies Y BongersAbstract:The objective was to evaluate the functional outcome after laparoscopic Sacrocolpopexy versus open Sacrocolpopexy in women with vault prolapse. A multicentre randomised controlled trial was carried out at four teaching and two university hospitals in the Netherlands in women with symptomatic vault prolapse requiring surgical treatment. Participants were randomised for laparoscopic or open Sacrocolpopexy. Primary outcome was disease-specific quality of life measured using the Urinary Distress Inventory (UDI) questionnaire at 12 months’ follow-up. Secondary outcomes included anatomical outcome and perioperative data. We needed 74 participants to show a difference of 10 points on the prolapse domain of the UDI 12 months after surgery (power of 80%, α error 0.05). Between 2007 and 2012, a total of 74 women were randomised. Follow-up after 12 months showed no significant differences in domain scores of the UDI between the two groups. After 12 months, both groups reported a UDI score of 0.0 (IQR: 0–0) for the domain “genital prolapse”, which was the primary outcome. There were no significant differences between the two groups (p = 0.93). The number of severe complications was 4 in the laparoscopic group versus 7 in the open abdominal group (RR 0.57; 95% CI 0.50–2.27). There was less blood loss and a shorter hospital stay after laparoscopy; 2 (IQR 2–3) versus 4 (IQR 3–5) days, which was statistically different. There was no significant difference in anatomical outcome at 12 months. Our trial provides evidence to support a laparoscopic approach when performing Sacrocolpopexy, as there was less blood loss and hospital stay was shorter, whereas functional and anatomical outcome were not statistically different.
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a comparison of complications between open abdominal Sacrocolpopexy and laparoscopic Sacrocolpopexy for the treatment of vault prolapse
Obstetrics and Gynecology International, 2013Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Tim P F M Van Der Heijden, Rutger A Stokmans, Ben Willem J Mol, Marlies Y BongersAbstract:Introduction. Sacrocolpopexy is a generally applied treatment for vault prolapse which can be performed laparoscopically or by open laparotomy. Methods. Between October 2007 and December 2012, we performed a multicenter prospective cohort study in 2 university and 4 teaching hospitals in the Netherlands. We included patients with symptomatic posthysterectomy vaginal vault prolapse requiring surgical treatment, who either had abdominal or laparoscopic Sacrocolpopexy. We studied surgery related morbidity, which was divided in pre-, peri-, and postoperative characteristics. Results. We studied 85 patients, of whom 42 had open abdominal and 43 laparoscopic Sacrocolpopexy. In the laparoscopic Sacrocolpopexy group, estimated blood loss was significantly less compared to the abdominal group: 192 mL (±126) versus 77 mL (±182), respectively (P ≤ .001). Furthermore, hospital stay was significantly shorter in the laparoscopic group (4.2 days) as compared to the abdominal group (2.4 days) (P ≤ .001). The overall complication rate was not significantly different (P = .121). However there was a significant difference in favor of the laparoscopic group in peri- and postoperative complications requiring complementary (conservative) treatment and/or extended admittance (RR 0.24 (95%-CI 0.07-0.80), P = .009). Conclusion. Laparoscopic Sacrocolpopexy reduces blood loss and hospital stay as compared to abdominal Sacrocolpopexy and generates less procedure related morbidity.
Daniel S Elliott - One of the best experts on this subject based on the ideXlab platform.
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long term quality of life outcomes and retreatment rates after robotic Sacrocolpopexy
International Journal of Urology, 2015Co-Authors: Brian J Linder, George K Chow, Daniel S ElliottAbstract:Objective To evaluate the long-term outcomes and potential predictors of treatment failure after robotic Sacrocolpopexy. Methods We identified 70 consecutive patients from 2002 to 2012 with symptomatic post-hysterectomy vaginal vault prolapse that underwent robotic Sacrocolpopexy. Multiple clinical and surgical variables were evaluated for potential association with treatment failure, which was defined as any repeat operation for recurrent prolapse or mesh-related complications. Results The median age at surgery was 67 years (interquartile range 59–74 years) and median follow up was 72 months (interquartile range 39–114 months). Overall, six out of 70 patients (8.6%) underwent a total of six secondary surgeries, including four for recurrent prolapse (two anterior repairs, one posterior repair, one apical) and two mesh complications. No patient-related factors were associated with the risk of repeat surgery: age (P = 0.45), diabetes mellitus (P = 0.24), tobacco use (P = 0.61) or prior prolapse surgery (P = 0.1) on univariate analysis. Freedom from repeat prolapse surgery or surgery for mesh complication was 98% at 1 year, 95% at 3 years and 90% at 6 years. At last follow up, 80% of patients reported that they would or probably would recommend robotic Sacrocolpopexy to a family member or friend. Conclusions Robotic Sacrocolpopexy is associated with excellent long-term outcomes. Recognition of long-term success is important for preoperative patient counseling.
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long term results of robotic assisted laparoscopic Sacrocolpopexy for the treatment of high grade vaginal vault prolapse
The Journal of Urology, 2006Co-Authors: Daniel S Elliott, Amy E Krambeck, George K ChowAbstract:Purpose: Transabdominal Sacrocolpopexy is a definitive treatment option for vaginal vault prolapse with durable success rates. However, it is associated with increased morbidity compared with vaginal repairs. We describe a minimally invasive technique of vaginal vault prolapse repair and present our experience with a minimum of 1 year followup.Materials and Methods: The surgical technique involves 5 laparoscopic ports: 3 for the da Vinci® robot and 2 for the assistant. A polypropylene mesh is attached to the sacral promontory and vaginal apex using polytetrafluoroethylene sutures. The mesh material is then covered by peritoneum. Patient analysis focused on complications, urinary continence, patient satisfaction and morbidity with a minimum of 12 months followup.Results: A total of 30 patients with post-hysterectomy vaginal vault prolapse underwent robotic assisted laparoscopic Sacrocolpopexy at our institution and 21 have a minimum of 12 months followup. Mean followup was 24 months (range 12 to 36) and me...
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robotic assisted laparoscopic Sacrocolpopexy for treatment of vaginal vault prolapse
Urology, 2004Co-Authors: David S Di Marco, George K Chow, Matthew T Gettman, Daniel S ElliottAbstract:Abstract Introduction To describe and demonstrate the use and benefit of robotic-assisted laparoscopic Sacrocolpopexy in the treatment of posthysterectomy vaginal vault prolapse. Technical considerations The procedure combines the use of standard laparoscopy with the daVinci robotic system. The patient is placed in the dorsal lithotomy position. One camera port, two robotic ports, and two standard laparoscopic ports are placed transperitoneally. Standard laparoscopic dissection, in combination with an intravaginal retractor, is used for initial anterior and posterior vaginal mobilization and exposure of the sacral promontory. The daVinci robot is then docked and used to suture a silicone Y -shaped graft from the vagina to the sacral promontory. Culdoplasty, with plication of the uterosacral ligaments, is then performed, with the final step, retroperitonealization of the graft. Conclusions A total of 5 women have undergone this procedure, 3 with concomitant pubovaginal sling placement. All 5 women were discharged after 24 hours. No complications from the Sacrocolpopexy were reported; however, 1 patient experienced transient vaginal bleeding related to the pubovaginal portion of the case. No recurrent anterior, posterior, or apical prolapse has occurred at mean of 4 months of follow-up. Using a robotic system for laparoscopic Sacrocolpopexy facilitated precise intracorporeal suture placement so that the procedure could be done in a fashion similar to that of the open method. Robotic-assisted laparoscopic Sacrocolpopexy may provide the same long-term durability of open Sacrocolpopexy with the benefit of a minimally invasive approach.
Ben Willem J Mol - One of the best experts on this subject based on the ideXlab platform.
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laparoscopic Sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse a randomized controlled trial salto 2 trial study protocol
BMC Women's Health, 2017Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Ben Willem J Mol, J. Veen, Melanie N Van Ijsselmuiden, Jan Paul W R Roovers, Marlies Y BongersAbstract:Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal Sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic Sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy as the treatment of vaginal vault prolapse. We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic Sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic Sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.
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Laparoscopic Sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol
BMC Women's Health, 2017Co-Authors: Annelotte W M Coolen, Ben Willem J Mol, Mèlanie N. Ijsselmuiden, Anique M. J. Oudheusden, J. Veen, Hugo W. F. Eijndhoven, Jan Paul Roovers, Marlies Y BongersAbstract:Background Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal Sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic Sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic Sacrocolpopexy as the treatment of vaginal vault prolapse. Methods We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic Sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included. Discussion The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic Sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse. Trial registration Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.
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laparoscopic Sacrocolpopexy compared with open abdominal Sacrocolpopexy for vault prolapse repair a randomised controlled trial
International Urogynecology Journal, 2017Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Ben Willem J Mol, Jan Paul W R Roovers, Marlies Y BongersAbstract:The objective was to evaluate the functional outcome after laparoscopic Sacrocolpopexy versus open Sacrocolpopexy in women with vault prolapse. A multicentre randomised controlled trial was carried out at four teaching and two university hospitals in the Netherlands in women with symptomatic vault prolapse requiring surgical treatment. Participants were randomised for laparoscopic or open Sacrocolpopexy. Primary outcome was disease-specific quality of life measured using the Urinary Distress Inventory (UDI) questionnaire at 12 months’ follow-up. Secondary outcomes included anatomical outcome and perioperative data. We needed 74 participants to show a difference of 10 points on the prolapse domain of the UDI 12 months after surgery (power of 80%, α error 0.05). Between 2007 and 2012, a total of 74 women were randomised. Follow-up after 12 months showed no significant differences in domain scores of the UDI between the two groups. After 12 months, both groups reported a UDI score of 0.0 (IQR: 0–0) for the domain “genital prolapse”, which was the primary outcome. There were no significant differences between the two groups (p = 0.93). The number of severe complications was 4 in the laparoscopic group versus 7 in the open abdominal group (RR 0.57; 95% CI 0.50–2.27). There was less blood loss and a shorter hospital stay after laparoscopy; 2 (IQR 2–3) versus 4 (IQR 3–5) days, which was statistically different. There was no significant difference in anatomical outcome at 12 months. Our trial provides evidence to support a laparoscopic approach when performing Sacrocolpopexy, as there was less blood loss and hospital stay was shorter, whereas functional and anatomical outcome were not statistically different.
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a comparison of complications between open abdominal Sacrocolpopexy and laparoscopic Sacrocolpopexy for the treatment of vault prolapse
Obstetrics and Gynecology International, 2013Co-Authors: Annelotte W M Coolen, Anique M J Van Oudheusden, Hugo W F Van Eijndhoven, Tim P F M Van Der Heijden, Rutger A Stokmans, Ben Willem J Mol, Marlies Y BongersAbstract:Introduction. Sacrocolpopexy is a generally applied treatment for vault prolapse which can be performed laparoscopically or by open laparotomy. Methods. Between October 2007 and December 2012, we performed a multicenter prospective cohort study in 2 university and 4 teaching hospitals in the Netherlands. We included patients with symptomatic posthysterectomy vaginal vault prolapse requiring surgical treatment, who either had abdominal or laparoscopic Sacrocolpopexy. We studied surgery related morbidity, which was divided in pre-, peri-, and postoperative characteristics. Results. We studied 85 patients, of whom 42 had open abdominal and 43 laparoscopic Sacrocolpopexy. In the laparoscopic Sacrocolpopexy group, estimated blood loss was significantly less compared to the abdominal group: 192 mL (±126) versus 77 mL (±182), respectively (P ≤ .001). Furthermore, hospital stay was significantly shorter in the laparoscopic group (4.2 days) as compared to the abdominal group (2.4 days) (P ≤ .001). The overall complication rate was not significantly different (P = .121). However there was a significant difference in favor of the laparoscopic group in peri- and postoperative complications requiring complementary (conservative) treatment and/or extended admittance (RR 0.24 (95%-CI 0.07-0.80), P = .009). Conclusion. Laparoscopic Sacrocolpopexy reduces blood loss and hospital stay as compared to abdominal Sacrocolpopexy and generates less procedure related morbidity.
