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临床试验/NCT04332315
NCT04332315已完成不适用

Short and Middle Term Results of Vaginally Assisted Laparoscopic Sacropolpopexy

Bezmialem Vakif University0 个研究点目标入组 87 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
主要终点
Middle term failure

研究概览

简要总结

Introduction and Hypothesis: Vaginally assisted laparoscopic sacrocolpopexy (VALS), which is a combined surgical approach where a vaginal hysterectomy is initially performed, followed by transvaginal placement of synthetic mesh and laparoscopic suspension, can be an alternative to overcome the dissection, suturing limitations of laparoscopic sacrocolpopexy. The aim of this study was to compare the middle term anatomic outcomes, complication rates, and operative times of patients with uterovaginal prolapse undergoing VALS with those of women undergoing abdominal sacrocolpopexy.

Methods: This is a prospective cohort study that evaluates operation times, anesthesia times, estimated blood loss, middle term outcomes, perioperative and postoperative complications. We compared the results of 47 women who had the VALS to that of 32 abdominal sacrocolpopexy.

详细描述

This is a prospective cohort study comparing VALS method to AS with concurrent hysterectomy in patients advanced symptomatic utero vaginal prolapse stage 3 or 4 according to Pelvic Organ Prolapse Quantification (POP-Q) system. This study was carried out from July 2015 to December 2018. Women suffering from prolapse and who desired surgical correction of their prolapse were included to trial. Fertile women who have not completed their family and women with previous POP surgery, POP stage ≤ 2 and women who prefer conservative management or uterus sparing surgery were excluded from the study. Written informed consent was obtained from all patients before enrolment. This study was approved by the institutional review board. Demographic data including age at surgery, parity, menopausal status, body mass index (BMI), previous pelvic surgeries (hysterectomy, pelvic floor repair, etc.), and comorbidities were obtained from the patient's medical records.

Operations:

The VALS procedure consists of two steps. First, vaginal hysterectomy or laparoscopically assisted vaginal hysterectomy performed, anterior vaginal wall dissected up to bladder neck starting from initial vaginal incision, posterior vaginal wall dissected from rectum starting from initial vaginal incision up to distal third of posterior vaginal wall. At this step, eversion of the vaginal walls with the aid of surgeon's fingers would facilitate dissection sharply or bluntly. Two hand-sewn, 15 cm long, 3 cm width type 1 polypropylene meshes transfixed to anterior and posterior vaginal wall with 4-6 polyglactin suture to each wall. The free arms of fixed meshes are introduced to the peritoneal cavity and the vaginal vault is closed with absorbable polyglactin suture. Mid urethral sling and/or perineoplasty were performed vaginally before laparoscopy. After changing gloves of surgery team and setting of endoscopy unit, laparoscopy phase was performed with one intraumbilical (10 mm), 3 lateral abdominal (5 mm) trocars. The sacral promontory is identified and the overlying peritoneum is opened up to vaginal cuff laterally to the rectum and medially to the right uterosacral ligament. Two mesh strips fixated to anterior longitudinal ligament of the sacrum with two separate no: 1 polypropylene sutures without tension. The mesh was then peritonealized with absorbable interrupted extracorporeal sutures.

AS was performed via Pfannenstiel incision after total or subtotal abdominal hysterectomy was performed regarding the surgeon's choice or presence of cervical pathology. Sacrocolpopexy was performed similar to laparoscopic sacrocolpopexy. The rectosigmoid colon was reflected to the left of the midline to expose the presacral area. The sacral promontory is identified and the overlying peritoneum is opened vertically with scissors by sharp dissection up to vaginal cuff laterally to the rectum and medially to the right uterosacral ligament. After placing a sponge stick or sizer to vagina for manipulation and easy identification of dissection plane, anterior vaginal wall dissected from bladder and posterior vaginal wall dissected from rectum. The surgeon has decided the limit of anterior and posterior vaginal wall dissection. The type 1 polyprolene mesh cut and attached with polyprolpelene suture in a Y formation, typically with 5 cm arm length, 3 cm width and 15-18 cm total length. The appropriate length for each patient is determined intraoperatively. The arms of mesh transfixed to anterior and posterior vaginal wall with 4-6 polyglactin suture to each wall starting from distally. Long arm of mesh fixated to anterior longitudinal ligament of the sacrum with two separate no: 1 polypropylene sutures without tension. The excess mesh parts were trimmed over the sacral promontory after the fixation. The mesh was then reperitonealized with absorbable sutures.

We recorded operation times, anesthesia time, additional procedures time, estimated blood loss, outcomes, perioperative and postoperative complications. Anesthesia time began with the anesthetic induction and ended with recovering from anesthesia and transfer of patient to recovery room, including positioning, skin preparation, covering and surgical equipment set up. The total operating time began with the first skin incision and ended with the last closure of an incision. Exclusive operation time of index procedures was calculated by subtracting the additional surgery time from the total operation time.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women suffering from prolapse and who desired surgical correction of their prolapse were included to trial.

排除标准

  • Fertile women who have not completed their family and women with previous POP surgery, POP stage ≤ 2 and women who prefer conservative management or uterus sparing surgery were excluded from the study.

结局指标

主要结局

Middle term failure

时间窗: 2 years

stage II or greater apical prolapse, with the leading edge of the C point to 1 cm on either side of the introitus that requires surgical treatment

次要结局

  • subjective failure(2 years)
  • anatomic failure(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serdar Aydın

Associate Prof

Bezmialem Vakif University

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Vaginally Assisted Laparoscopic Sacropolpopexy | 临床试验