Comparison of Vaginal Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Operative time (minutes)
研究概览
简要总结
Post-hysterectomy vaginal vault prolapse is a common pelvic floor disorder described as descent of the vaginal apex after hysterectomy. The incidence of post-hysterectomy vault prolapse has been reported to follow 11.6% of hysterectomies performed for prolapse and 1.8% for other benign diseases. The majority of surgical repairs to correct post-hysterectomy vault prolapse are approached via a transvaginal route. A common transvaginal procedure to correct vaginal vault prolapse is the uterosacral ligament suspension. Traditionally, the uterosacral ligaments have been accessed intraperitoneally to perform the vaginal suspension. More recently, an extraperitoneal approach has been utilized with good results. There is limited evidence comparing the the two approaches. Thus, the objectives of this study are to compare compare operative time, hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches.
详细描述
This is a single-center, randomized, single-blind surgical trial of women with post-hysterectomy vaginal vault prolapse desiring surgical treatment. The purpose of this study is to compare outcomes of vaginal intraperitoneal uterosacral ligament suspensions and vaginal extraperitoneal uterosacral ligament suspensions for the treatment of post-hysterectomy vaginal vault prolapse. The primary objective will be to compare operative time between the two approaches. Secondary objectives of the trial will be to compare hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches through 12 months using assessments at six weeks, six months, and twelve months.
The study will include subjects with stage 1-4 pelvic organ prolapse and descent of the vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C ≥ -TVL/2) that desire vaginal surgical management for post-hysterectomy vaginal vault prolapse. Subjects enrolled into the trial will be randomized to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension with a 1:1 allocation using a computer-generated randomization schedule. Patients will be blinded to their allocation. Patients in both groups will receive the same standard of care for vaginal procedures as it currently exists in out practice. This involves the standard anesthetics and opioid medications intraoperatively. Randomization will be revealed to the surgeons in the operating room once the patient is under general anesthesia.
Intraoperative data to be collected will include, operative time (minutes from surgical incision time to surgery end time), estimated blood loss (ml), intraoperative complications, and concurrent surgical procedures.
Preoperative and postoperative clinical measures to be collected will include POPQ examination points and scores from three validated questionnaires (Pelvic Floor Disability Index (PFDI-20) questionnaire, Pelvic Floor Impact Questionnaires (PFIQ-7) and the Pelvic and Incontinence Sexual Questionnaire (PISQ-12)). Postoperative clinical measures will be collected at six week, six month, and twelve month post-operative visits.
Surgical success or failure will be evaluated as a dichotomous composite outcome(objective measures (POPQ examination points) and subjective measures(validated questionnaires) at six week, six month, and twelve month post-operative visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are 18 years of age or greater
- •English speaking
- •Stage 1 or greater post-hysterectomy vaginal vault prolapse
- •Descent of vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C ≥ -TVL/2)
- •Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure
排除标准
- •Non-English speaking or not able to provide informed consent
- •Combined surgical cases with other surgical specialties
- •Women unable to follow up postoperatively
结局指标
主要结局
Operative time (minutes)
时间窗: Day of surgery
Minutes from surgical incision time to surgery end time
次要结局
- Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 week postoperative visit(6 week)
- Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 12 month postoperative visit(12 month)
- Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 week postoperative visit(6 week)
- Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 week postoperative visit(6 week)
- Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 month postoperative visit(6 month)
- Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 12 month postoperative visit(12 month)
- Estimated blood loss (ml)(Day of surgery)
- Frequency of perioperative complications (%)(6 week)
- Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 month postoperative visit(6 month)
- Hospital length of stay (hours)(Up to 7 days)
- Surgical encounter total direct costs ($)(Up to 7 days)
- Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 month postoperative visit(6 month)
- Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 12 month postoperative visit(12 month)
- Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 6 month postoperative visit(6 month)
- Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 12 month postoperative visit(12 month)
- Mean postoperative numerical rating scale (NRS) score of pain intensity at 1 week after surgery(1 week)
研究者
Danny Mounir
Clinical Fellow
The Methodist Hospital Research Institute