Long-term Data on Graft-Related Complications After Sacrocolpopexy With Lightweight Compared With Heavier-Weight Mesh.

OBJECTIVE: To estimate the long-term incidence and characteristics of graft-related complications, rate of reintervention for graft-related complications and prolapse, and subjective and anatomical outcomes after laparoscopic sacrocolpopexy with heavier-weight (more than 44 g/m2) compared with lightweight (28 g/m2) polypropylene mesh, the latter with resorbable poliglecaprone component. METHODS: We conducted a single-center study that compared two consecutive prospective cohorts of patients who were undergoing laparoscopic sacrocolpopexy for symptomatic stage 2 or greater cervical or vault prolapse, by using either heavier-weight polypropylene mesh or lightweight polypropylene mesh at a similar duration of follow-up. The primary outcome was the occurrence of graft-related complications and their nature. Secondary outcomes included reinterventions for graft-related complications, recurrent apical prolapse, a subjective outcome (PGIC [Patient Global Impression of Change] score 4 or higher), and an anatomical outcome (point C -1 cm or greater). RESULTS: We identified consecutive patients: 101 were implanted with heavier-weight polypropylene, and 238 were implanted with lightweight polypropylene; all were audited at comparable follow-up times (heavier-weight mesh: 97 months [interquartile range 16 months]; lightweight mesh: 92.5 months [interquartile range 58 months]). Graft-related complications were more frequent in patients with heavier-weight than lightweight mesh (22.8% [23/101] vs 7.3% [13/178]; hazard ratio [HR] 3.3, 95% CI 1.6-7.1), more frequently symptomatic (heavier-weight mesh: 16.8% [17/101] vs lightweight mesh: 2.8% [5/178]; HR 6.0, 95% CI 2.5-14.3), and more frequently lead to reintervention for graft-related complications (heavier-weight mesh: 18.8% [19/101] vs lightweight mesh: 2.1% [5/238]; HR 4.6, 95% CI 1.9-11.2). The vast majority of patients improved (PGIC score 4 or higher), without difference between groups (heavier-weight mesh: 71/84 [84.9%]; lightweight mesh: 154/178 [86.5%]; HR 0.8, 95% CI 0.6-1.1); neither was there a difference in anatomical failure rate (heavier-weight mesh: 1/60 [1.7%] vs lightweight mesh: 8/131 [6.1%]; HR 0.3, 95% CI 0.1-1.4). Reoperations for recurrent vault prolapse were scarce (0.0% in heavier-weight mesh, vs 0.4% in lightweight mesh). CONCLUSION: In two consecutive cohorts, the number of graft-related complications, symptomatic graft-related complications, and reinterventions for graft-related complications were higher in patients implanted with heavier-weight polypropylene than when lightweight polypropylene was used. There were no differences in subjective, objective outcomes, and reoperation rates for prolapse. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04378400. FUNDING: To assist in this audit, the University Hospitals Leuven received support from Ethicon Endosurgery.

Long-Term Assessment of a Prospective Cohort of Patients Undergoing Laparoscopic Sacrocolpopexy.

OBJECTIVE: To report long-term outcomes after laparoscopic sacrocolpopexy. METHODS: We conducted a prospective descriptive cohort study on 331 consecutive patients who underwent laparoscopic sacrocolpopexy for symptomatic prolapse (Pelvic Organ Prolapse Quantification [POP-Q] system stage 2 or greater) at one center, with minimum 1.5 years of follow-up by April 30, 2014. Primary outcome measures were Patient Global Impression of Change score and failure at the apex (C≥-1 cm; POP-Q stage 2 or greater). Secondary outcomes were anatomical failure in other compartments, duration of follow-up, occurrence and time point of complications, reinterventions, and functional outcomes by response to a standardized 24-question interview on prolapse and bladder, bowel, and sexual function. Assessment was by an experienced clinician not involved in patient management. RESULTS: The follow-up rate was 84.6% (280/331); 185 of 331 (55.9%) patients were both physically examined and interviewed, and 95 of 331 (25.7%) were interviewed only. The median age at interview was 72 years (interquartile range 13 years), with a follow-up period of 85.5 months (interquartile range 46 months). Approximately 83% (231/280) reported improvement; 5.7% (16/280) were unchanged, 5.7% (16/280) felt slightly worse, and 6.8% (17/280) reported clear deterioration. Anatomical failure at point-C was 8.6% (16/185); anterior (22.2%, 41/185) and posterior (28.6%, 53/185) prolapse were more common than apical prolapse. Of those with level-I anatomical cure, 10.1% (17/185) felt worse; half of them (9/17) because of prolapse in another compartment. The others had urinary problems (41.2%, 7/17), obstructive defecation (11.8%, 2/17), or dyspareunia (11.8%, 2/17). Conversely, the majority of patients with recurrence at the vault (62.5%, 10/16) self-reported to be improved. The reoperation rate was 17.8% (48/270), including 19 (7.0%) for graft-related complications and nine (3.3%) for prolapse. CONCLUSION: More than four out of five patients (82.5%) felt improved 86 months after laparoscopic sacrocolpopexy. Of those not improved, two thirds had recurrent prolapse; however, typically mid-vaginal. The other third reported urinary or bowel problems or dyspareunia. Reintervention for prolapse was 3.3%. The most common reasons for reoperation were graft-related complications (7.0%) and urinary incontinence (6.7%).

The challenge of implementing laparoscopic sacrocolpopexy.

Vaginal-vault prolapse is effectively treated using sacrocolpopexy (SCP). A randomized trial demonstrated that it can be performed as effectively via laparoscopy (LSCP) as via laparotomy and with less morbidity. This evidence begs the question of how units offering abdominal sacrocolpopexy will implement LSCP. Several limitations need to be overcome. LSCP initially requires longer operating time; however, that decreases with surgeon experience. To decrease operation time, suture training can be implemented ahead. Following a 15-h suturing lab, trainees achieved comparable operation times after 30 cases. Dissection is another critical time-consuming step and is difficult to model. Proficiency is more dependent on patient characteristics, though this component is poorly studied. One experience showed it takes 60 procedures to effectively limit complications. The large number of patients required for surgeon training for this relative infrequent operation creates a problem, thus limiting the number of centers available for training surgeons within a reasonable period.

Analysis of the learning process for laparoscopic sacrocolpopexy: identification of challenging steps.

INTRODUCTION AND HYPOTHESIS: We earlier demonstrated that the operation time of laparoscopic sacrocolpopexy (LSCP) by an experienced surgeon drops significantly after 30 cases to reach a steady state after 90. We now aimed to define the learning curve and to identify the most challenging steps for a trainee learning LSCP. METHODS: Prospective consecutive series of 60 patients undergoing LSCP performed by a trainee experienced in operative laparoscopy but not LSCP. Prior to the first case, the trainee primed his endoscopic suturing skills on an endotrainer for 15 h. His operation time and performance score were analysed using moving average analysis (MOA). The former and the occurrence of complications or short-term failures were compared with those of a concurrent control group consisting of patients operated on by a surgeon experienced in LSCP (teacher). The procedure was empirically divided into five consecutive steps (dissection of the promontory, the paracolic gutter and vagina, suturing of the mesh to the vault, stapling to the promontory, and peritonealisation). RESULTS: The MOA of the operation time demonstrated a learning curve for all steps, except for the dissection of and fixation to the promontory. The most time-consuming step is the dissection of the vault, for which it took the trainee 31 procedures to achieve an operation time comparable to that of the teacher. Also, the quality of the dissection improved over time. Suturing of the implant to the vault and peritonealisation took only 10 and 6 procedures respectively. There was no difference in the occurrence of major complications and in one case the trainee asked for assistance. CONCLUSION: Quality of LSCP improves with experience. Operation time falls as well, and the most time-consuming step is the dissection of the paracolic and perivaginal spaces. Prior training in laparoscopic suturing coincided with a short learning process for the phases requiring suturing.

Clinicopathological study of patients requiring reintervention after sacrocolpopexy with xenogenic acellular collagen grafts.

PURPOSE: We describe the operative and histopathological findings of patients requiring reintervention because of symptomatic vault prolapse or graft related complications following sacrocolpopexy using xenografts. MATERIALS AND METHODS: A total of 13 patients underwent secondary sacrocolpopexy because of failure (8) or vaginal revision (5) because of a graft related complication after the initial sacrocolpopexy with porcine dermal collagen (9) or small intestinal submucosa (4). Outcome measures were operative findings and histology of specimens obtained at reintervention. Sections were semiquantitatively scored for the presence of infection, foreign body reaction and fibrosis by a pathologist blinded to the outcome and graft type. RESULTS: Reinterventions for failure and graft related complications were performed a median of 33 and 15 months, respectively, after the initial operation. Pathology of porcine dermal collagen failures (6) revealed local degradation associated with a minimal foreign body reaction. Porcine dermal collagen remnants were surrounded by minimal fibrosis and neovascularization. Small intestinal submucosa implants of failures (2) were entirely replaced by collagen rich and moderately vascularized connective tissue. Pathology of 3 erosions (all 3 porcine dermal collagen) revealed a locally degraded implant that was surrounded by histiocytes and a polymorphonuclear infiltrate. Pathology of 2 early infections, both small intestinal submucosa, revealed a massive polymorphonuclear infiltration with the implant material remodeled and replaced by loose connective tissue. CONCLUSIONS: In these clinical recurrences porcine dermal collagen implants were usually locally degraded but still recognizable several years after implantation. Small intestinal submucosa implants were fully replaced by connective tissue. Therefore, the cause of recurrence remains unclear. Porcine dermal collagen erosions displayed features of infection and degradation.

Validity, reliability and responsiveness of a Dutch version of the prolapse quality-of-life (P-QoL) questionnaire.

INTRODUCTION AND HYPOTHESIS: We aimed to test validity, reliability and responsiveness of a Dutch version of a prolapse quality-of-life questionnaire (P-QoL). METHODS: P-QoL was translated into Dutch and adjusted by a panel of five experts. The scores of the final version were compared between symptomatic (n = 160) and asymptomatic (n = 80) patients and with findings on vaginal examination (pelvic organ prolapse quantification (POP-Q)). In terms of reliability, Cronbach's alpha was calculated, and a test-retest (n = 20) was performed. Responsiveness to treatment was assessed by comparing pre- and postoperative scores in 45 patients. RESULTS: Total scores for each P-QoL domain were different between symptomatic and asymptomatic women (p < 0.001). Severity according to P-QoL correlated well with POP-Q findings. Cronbach's alphas showed internal consistency within the domains. Test-retest reliability was high. Pre- and postoperative scores for each domain were significantly different (p < 0.001). CONCLUSION: The Dutch version of P-QoL is valid, reliable and responsive to assess quality-of-life and symptoms in Dutch-speaking patients with urogenital prolapse.

Sacrocolpopexy using xenogenic acellular collagen in patients at increased risk for graft-related complications.

AIMS: We studied the long-term anatomical and functional outcome following sacrocolpopexy for apical vaginal prolapse using xenogenic grafts in a population at increased risk for graft-related complications (GRCs). METHODS: Twenty-two consecutive patients with symptomatic apical prolapse were scheduled for laparoscopic sacrocolpopexy (LSC) with porcine grafts because they were presumed to be at risk for GRC, because of pre-existing vaginal ulcerations (n = 4), concomitant vaginal prolapse repair (n = 15), total hysterectomy (n = 1), or intra-operative abdominal contamination due to accidental laceration of the vagina, bowel perforation (n = 1) or the presence of infection (n = 1). Either small intestinal submucosa (n = 8) or dermal collagen (n = 14) was used. Outcome measures were GRCs, anatomical cure (

A randomized controlled trial of misoprostol and sulprostone to end pregnancy after fetal death.

Objective. To compare effectiveness, side effects, and patients' perception of vaginal misoprostol versus intravenous sulprostone for ending pregnancy after fetal death between 14 and 42 weeks gestation. Method. Multicenter randomized controlled trial, using block randomization, central allocation, and prior power analysis. Outcome measures. Induction-delivery interval, gastrointestinal side effects, use of analgesia, pain perception, pyrexia, placental retention, hemorrhage, and women's opinions. Results. Of 176 women aimed for, 143 were randomized over 7 years, of whom 4 were excluded. There was no difference in delivery within 24 and 36 hours: 91.4% and 97.1% with misoprostol (n = 70) versus 85.5% and 92.8% with sulprostone (n = 69). There was no difference in either gastrointestinal side effects, as reported by the women and their caregivers, use of analgesia, women's pain perception, blood loss or placental retention. Hyperthermia >/=38 degrees C was more common with misoprostol (24.3%) than with sulprostone (11.6%; difference: +12.7%; 95% CI: +1.2% to +25.3%) and related to the total dose used. Acceptability of both induction methods was similar except for freedom of movement, which was substantially in favor of misoprostol (lack of freedom reported with misoprostol in 34.3% versus 63.8% with sulprostone; difference: -29.5%; 95% CI: -13.6% to -45.4%). Conclusions. Misoprostol and sulprostone are similarly effective with little difference in side effects except for hyperthermia, related to the dose of misoprostol used, and women's reported lack of mobility with intravenous sulprostone. Effectiveness of both methods increased with gestational age.

Medium term outcome of laparoscopic sacrocolpopexy with xenografts compared to synthetic grafts.

PURPOSE: We compared the medium term anatomical and subjective outcome, and graft related complications after sacrocolpopexy for apical vaginal prolapse using xenogenic or polypropylene grafts. MATERIALS AND METHODS: We prospectively studied 50 consecutive patients who underwent laparoscopic sacrocolpopexy with porcine grafts of small intestinal submucosa (21) or dermal collagen (29). We compared these patients to 100 consecutive controls in whom polypropylene was used, and underwent surgery before (50) or after (50) the cases. The primary outcome was anatomical cure (stage I or less at any compartment). Secondary outcomes were graft related complications, subjective cure and quality of life evaluated by clinical examination, standardized interview and prolapse specific questionnaire, respectively. RESULTS: At study closure 129 (86%) patients were available for functional evaluation and 104 (67%) were available for anatomical evaluation. Mean postoperative followup (+/-33 months) and baseline characteristics except age were comparable. The overall anatomical failure rate was comparable (49% vs 34%, p = 0.053) but failures at the vault (21% vs 3%, p <0.01) and posterior compartment (36% vs 19%, p <0.05) were more frequent in the xenograft group. There were 6 reoperations including secondary laparoscopic sacrocolpopexy (5) and cystocele repair (1), all confined to the xenograft group (p <0.01). Graft related complications were equally frequent (11%) in the xenograft and polypropylene groups. The reoperation rate for graft related complications was not different (xenograft 3% vs controls 11%, p = 0.20). There were no differences in functional outcome and quality of life between xenografts and controls. CONCLUSIONS: While overall anatomical failure was comparable, sacrocolpopexy using xenograft was associated with more apical failures and reoperations for prolapse than with polypropylene without differences in functional outcome. The use of xenografts did not decrease the number of graft related complications.

Implementation of laparoscopic sacrocolpopexy--a single centre's experience.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to describe the learning curve of a single surgeon to achieve the ability to perform a complication-free and anatomically successful laparoscopic sacrocolpopexy (LSC). METHODS: All patients, from the first LSC onwards (1996) were included. Outcome measures were operation time, number of laparotomies, complications and anatomical failures within 3 months. Learning curves were generated using moving average method (MOA) and cumulative sum (CUSUM) analysis to assess changes in respectively operation time and failures (laparotomy, complication or anatomical failure). RESULTS: Of the 206 patients, 83% were completed by laparoscopy. The intra-operative and major respectively minor post-operative complication rates were 2.4% (n = 5), 4.4% (n = 9) and 12.6% (n = 26). CUSUM analysis showed adequate learning after 60 cases. MOA showed that operation time declined rapidly during the first 30 procedures reaching a steady state (175 min) after 90 cases. Complications remained unchanged throughout the series. CONCLUSIONS: LSC was associated with a low complication rate but a long learning curve.

Medium-term anatomic and functional results of laparoscopic sacrocolpopexy beyond the learning curve.

BACKGROUND: Limited prospective data on the anatomic and functional outcome after laparoscopic sacrocolpopexy (LSC) are available in the literature. OBJECTIVE: To describe the medium-term anatomic and functional outcome of LSC. DESIGN, SETTING, AND PARTICIPANTS: Prospective consecutive series of 132 women with vaginal vault prolapse undergoing LSC between 2001 and 2006, which was after our learning curve. Patients with urodynamically proven stress incontinence (SI) underwent a concomitant tension-free vaginal tape (TVT) procedure. INTERVENTION: Patients underwent LSC with a polypropylene implant. MEASUREMENTS: Principal outcome measures were anatomic cure (stage 1 or lower) assessed by the Pelvic Organ Prolapse Quantification (POPQ) system and subjective cure and impact on quality of life measured by a standardised interview and, since its introduction in 2004, by a prolapse-specific quality-of-life questionnaire (P-QOL). RESULTS AND LIMITATIONS: At a mean follow-up of 12.5 mo, the anatomic cure rate for the apex was 98%. Anatomic failures elsewhere were mainly at the posterior compartment (18%). Subjective prolapse cure rate was 91.7%, and no patients required reoperation for recurrent prolapse. Symptoms of preoperative SI, urge incontinence, or constipation were cured in 43%, 46%, and 42% of patients, respectively. The rate of de novo SI was 7.3%. De novo constipation developed in 5% and de novo dyspareunia developed in 19%. Patients' quality of life improved significantly. Erosions occurred in 4.5%, all within 1 yr. A limitation of the study is that the quality-of-life assessment score became available halfway through the study, limiting the number of preoperative observations (n=36). CONCLUSIONS: We demonstrated that LSC results in good anatomic outcome and subjective cure of prolapse symptoms at medium term. The posterior compartment was most vulnerable for recurrence.

Fate of collagen-based implants used in pelvic floor surgery: a 2-year follow-up study in a rabbit model.

OBJECTIVE: The purpose of this study was to compare the long-term host response to 2 different collagen matrices versus macroporous polypropylene mesh. STUDY DESIGN: Four full-thickness abdominal wall defects in 35 rabbits were reconstructed with either polypropylene (Prolene), porcine dermal (Pelvicol), or small intestine submucosal collagen matrix (SIS). Animals were sacrificed on day 30, 60, 90, 180, 365, 540, and 720 days to evaluate morphologic and biomechanical properties of explants. RESULTS: Prolene provoked a fibrotic reaction within 30 days. SIS was entirely replaced by a thin fibrotic layer within 60 days. Pelvicol was encapsulated, remaining structurally unchanged up to 180 days. Thereafter, half underwent degradation by a foreign body reaction. CONCLUSION: Prolene was integrated by an increasingly organised fibrotic scar while SIS was entirely remodelled within 60 days. Pelvicol implants underwent late onset (> or = 180 days) degradation. After 2 years of implantation there were no differences in tensiometric strength between the 3 different materials.

The biology behind fascial defects and the use of implants in pelvic organ prolapse repair.

Implant materials are increasingly being used in an effort to reduce recurrence after prolapse repair with native tissues. Surgeons should be aware of the biology behind both the disease as well as the host response to various implants. We will discuss insights into the biology behind hernia and abdominal fascial defects. Those lessons from "herniology" will, wherever possible, be applied to pelvic organ prolapse (POP) problems. Then we will deal with available animal models, for both the underlying disease and surgical repair. Then we will go over the features of implants and describe how the host responds to implantation. Methodology of such experiments will be briefly explained for the clinician not involved in experimentation. As we discuss the different materials available on the market, we will summarize some results of recent experiments by our group.

Laparoscopic hysterectomy for benign diseases.

Despite more than 1000 publications on laparoscopic hysterectomy (LH), its role remains difficult to define. LH is not there to replace vaginal hysterectomy, but may be an alternative for abdominal hysterectomy when there are (relative) contraindications for vaginal hysterectomy, including concomitant oophorectomy, previous pelvic surgery and/or risk for adhesions, the larger uterus and nulliparity, and some oncological indications. Randomized trials have demonstrated that, compared to abdominal hysterectomy, LH shortens hospital stay and induces less postoperative pain and quicker recovery at the expense of a longer operation time. LH carries a higher risk for adjacent organ injury, and may be cost-effective, despite higher direct costs, because of the shorter hospital stay and quicker recovery.

Host response after reconstruction of abdominal wall defects with porcine dermal collagen in a rat model.

OBJECTIVE: The purpose of this study was to compare the inflammatory response after implantation of Pelvicol with Prolene in a rat model. STUDY DESIGN: Full-thickness abdominal wall defects were created in 64 Wistar rats, and reconstructed with either Pelvicol or Prolene. Animals were sacrificed on days 7, 14, 30, and 90 to evaluate the presence of herniation, infection, adhesions, and changes in thickness and tensile strength of the implants. Histopathology and immunohistochemistry were performed to evaluate the collagen deposition and the inflammatory response. Statistics were done with unpaired t test and Mann-Whitney rank test. RESULTS: Pelvicol implantation induced infiltration of granulocytes, macrophages, and NK cells, which showed up-regulated expression of surface activation markers ICAM-1 and CD11b. This inflammatory response was significantly milder, and declined faster than in Prolene-implanted rats, and was also associated with fewer adhesions. Moreover, Pelvicol induced a slower, but more orderly collagen deposition, paralleling the surface of the implant. Pelvicol implants showed a slower increase in thickness and tensile strength early on, but this difference disappeared by day 90. CONCLUSION: Pelvicol induces a milder inflammatory response, less adhesion formation, more orderly collagen deposition than Prolene, and reaches a comparable tensile strength only after 90 days.