Safety and Efficacy of Advanced Bipolar Vessel Sealing in Vaginal Hysterectomy: 1000 Cases.

STUDY OBJECTIVE: To determine the safety and efficacy of advanced electrothermal bipolar vessel sealing (EBVS) during vaginal hysterectomy by evaluating urinary complications, overall complications, and reoperation rate. DESIGN: A retrospective cohort (Canadian Task Force classification III). SETTING: High-volume gynecologic surgeon practice, private hospital. PATIENTS: One thousand consecutive patients who have undergone vaginal hysterectomy for benign conditions carried out with EBVS between January 2002 and December 2012. INTERVENTIONS: Vaginal hysterectomy performed using an EBVS device. MEASUREMENTS AND MAIN RESULTS: One thousand consecutive patients underwent vaginal hysterectomy with advanced EBVS between January 2002 and December 2012 with an average age of 51.4 ± 8.9 years (range, 31-88) and mean weight and body mass index of 57.4 ± 7.2 kg (range, 42-105) and 25.8 ± 4.2 kg/m2 (range, 19.1-38.9), respectively. Eighty-five percent of patients (852/1000) were healthy without any severe systemic disease. A single experienced surgeon performed all vaginal hysterectomies with EBVS, specifically by not applying traction during thermofusion to avoid hemorrhage, amputating the cervix to transform the uterus to an apple shape to facilitate a vaginal approach and rotation of the uterus, and placing bi-clamp forceps on the edge of the uterus and not at a 45- or 90-degree angle. Wound closure was completed with a continuous suture. Eleven urinary complications (1.1%) were recorded (10 bladder mechanical injuries and 1 vesicovaginal fistula). This was not statistically different from the rate of .64% previously reported in the FINHYST study (p = .15). The overall rate of complications was 5.3%, and 20 patients (2.0%) required reoperation. The presence of uterine scar tissue (odds ratio, 5.5; 95% confidence interval, 1.6-19.2) and larger uterus size (odds ratio, 2.5; 95% confidence interval, 1.01-19.2) were associated with a higher risk of urinary complications. CONCLUSION: The use of EBVS during vaginal hysterectomy results in urinary and overall complication rates of 1.1% and 5.3%, respectively, statistically similar to previously reported series that did not use EBVS. The use of advanced EBVS is a safe and effective method of achieving hemostasis during vaginal hysterectomy.

Polypropylene as a reinforcement in pelvic surgery is not inert: comparative analysis of 100 explants.

INTRODUCTION AND HYPOTHESIS: Currently, most implants used for reinforcement in surgical treatment of pelvic floor disorders are knitted monofilament polypropylene (PP). While previously recognized as inert, PP is associated with high complication rates. Some recent literature suggests polyester prosthetics based on poly(ethylene terephthalate) (PET), which may be more inert in vivo. METHODS: A sample of 100 implants explanted from patients due to complications was examined to evaluate the relative degradation characteristics of PP and PET prosthetics. Histological, microscopic (scanning electron microscopy, SEM) and chemical analysis (Fourier transform infrared (FTIR) spectroscopy and differential scanning calorimetry (DSC)) were conducted on these explants. RESULTS: Poly(ethylene terephtahlate) explants appeared to sustain less degradation in vivo than the PP explants observed in this cohort. CONCLUSIONS: This is the first study to evaluate synthetic implants used in a vaginal approach for pelvic floor reinforcement. The study provides evidence contrary to published literature characterizing PP as inert in such applications. Additionally, the study suggests the need for clinical trials comparatively investigating the performance of new types of monofilament prosthetics, such as those comprising PET.

Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: To evaluate clinical outcomes at 3 years following total transvaginal mesh (TVM) technique to treat vaginal prolapse. METHODS: Prospective, observational study in patients with prolapse ≥ stage II. Success was defined as POP-Q-stage 0-I and absence of surgical re-intervention for prolapse. Secondary outcome measures were: quality of life (QOL), prolapse-specific inventory (PSI), impact on sexual activity and complications. RESULTS: Ninety women underwent TVM repair, 72 a hysterectomy. Anatomical failure rate was 20.0% at 3 years. Three patients required re-intervention for prolapse. Improvements in QOL- and PSI-scores were observed at 1 and 3 years. Vaginal mesh extrusion occurred in 14.4% patients. After 3 years, 4.7% asymptomatic extrusions remained present. Of 61 sexually active women at baseline, a significant number of patients (41%) ceased sexual activity by 3 years; de novo dyspareunia was reported by 8.8%. One vesico-vaginal fistula resolved after surgery. CONCLUSION: Medium-term results demonstrate that the TVM technique provides a durable prolapse repair.

Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.

AIM: To study peri-surgical complications after cure of genital prolapse by vaginal route using interposition of synthetic prostheses Gynemesh Prolene Soft (Gynecare) following the Trans Vaginal Mesh (TVM) technique. METHODS: The present retrospective multicentered study comprised 684 patients who underwent surgery at seven French centers between October 2002 and December 2004. All patients had a genital prolapse >or=3 (C3/H3/E3/R3) according to International continence society (ICS) classification. According to each case, prosthetic interposition was total, or anterior only or posterior only. Patients were systematically seen 6 weeks, 3 months and 6 months after surgery. Multivaried statistical analysis followed a model of logistic regression applied to each post-surgical complication. RESULTS: The mean age of patients was 63.5 years (30-94). The mean follow-up period was 3.6 months. 84.3% of patients were post-menopause, 24.3% had hysterectomy, 16.7% previous cure of prolapse, and 11.1% cure of stress urinary incontinence (SUI). During the procedure, hysterectomy was combined in 50.3% of cases, cervix amputation in 1.5%, and cure of SUI in 40.9%. 15.8% were treated for a cystocele only. 14.8% had only a rectocele +/- elytrocele and 69.4% had a prolapse touching both compartments, anterior and posterior. In peri-surgical complications, (2%) were five bladder wounds (0.7%), one rectal wound (0.15%) and seven hemorrhages greater that 200 mL (1%). Among early post-surgical complications (during the first month after surgery) (2.8%) were two pelvic abscesses (0.29%), 13 pelvic hematomas (1.9%), one pelvic cellulitis (0.15%), two vesicovaginal fistulas and one rectovaginal fistula (0.15%). Among late post-surgical complications (33.6%) there were 77 granulomas or prosthetic expositions (11.3% [6.7% in the vaginal anterior wall, 2.1% in the vaginal posterior wall and 4.8% in the fornix]), 80 prosthetic retractions (11.7%), 36 relapse of prolapse (6.9%) and 37 SUI de novo (5.4%). Multivaried analysis shows that previous history of hysterectomy or placing of an isolated anterior prosthesis increase the risk of peri-surgical complication; preserved uterus and isolated posterior prosthesis lessen the risk of granulomas and prosthetic retractions; and association of a Richter's intervention increases the rate of prosthetic retractions. CONCLUSION: Cure of genital prolapse with synthetic prostheses interposed by vaginal route is now reliable and can be reproduced with a low rate of peri- and early post-surgical complications. However, our study shows a certain number of late post-surgical complications after insertion of strengthening synthetic vaginal implants (prosthetic expositions and prosthetic retractions). These retrospective results will soon be compared to a prospective study.