Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Degree of Rectal Hypermobility Measured Via Ultrasound
研究概览
简要总结
Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population.
Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms.
During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.
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
- None
盲法说明
The study surgeon is providing clinical care to enrolled subjects, thus masking the surgeon to treatment allocation or subject symptoms is not practical or feasible, other than the allocation concealment prior to surgical randomization. Given the surgical procedure requires a transvaginal or abdominal incision, it is clinically not possible to mask the participant or other research personnel.
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
- 否
入选标准
- •Female, between the age of 18 and 80
- •OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):
- •Do you feel you need to strain too hard to have a bowel movement?
- •Do you feel you have not completely emptied your bowels at the end of a bowel movement?
- •Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?
- •Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
- •Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
- •Patient who is not pregnant and does not intend to become pregnant in the next 2 years
- •Available for 24-months of follow-up
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Able to complete study assessments, per clinician judgment
- •Able and willing to provide independent written informed consent
- •Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries
排除标准
- •Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
- •History of previous surgery that included any type of surgery for rectal prolapse
- •Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
- •Previous adverse reaction to synthetic mesh
- •Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
- •History of two inpatient hospitalizations for medical comorbidities in the previous 12 months
结局指标
主要结局
Degree of Rectal Hypermobility Measured Via Ultrasound
时间窗: 24 months post-operatively
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
Degree of Rectal Hypermobility Measured Via Ultrasound
时间窗: 24 months post-operatively
The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).
次要结局
- Postoperative Pain Measured by Pain Scale(24 months post-operatively)
- Postoperative Pain Measured by Pain Medication Use(24 months post-operatively)
- Postoperative Functional Activity Level(24 months post-operatively)
- Global Improvement in Bladder Function(24 months post-operatively)
- Pelvic Floor Distress Inventory (PFDI) - POPDI(24 months post-operatively)
- Pelvic Floor Distress Inventory (PFDI) - CRADI(24 months post-operatively)
- Pelvic Floor Distress Inventory (PFDI) - UDI(24 months post-operatively)
- Quality of Life Measured by PFIQ(24 months post-operatively)
- Quality of Life Measured by SF-36(24 months post-operatively)
- Quality of Life Measured by EQ-5D(24 months post-operatively)
- Pelvic Muscle Strength(24 months post-operatively)
- Postoperative Pain Measured by Pain Scale(24 months post-operatively)
- Postoperative Pain Measured by Pain Medication Use(24 months post-operatively)
- Postoperative Functional Activity Level(24 months post-operatively)
- Global Improvement in Bladder Function(24 months post-operatively)
- Pelvic Floor Distress Inventory (PFDI) - POPDI(24 months post-operatively)
- Pelvic Floor Distress Inventory (PFDI) - CRADI(24 months post-operatively)
- Quality of Life Measured by PFIQ(24 months post-operatively)
- Quality of Life Measured by SF-36(24 months post-operatively)
- Quality of Life Measured by EQ-5D(24 months post-operatively)
- Pelvic Muscle Strength(24 months post-operatively)
研究者
Ghazaleh Rostami Nia
Director of Research Division of Urogynecology, NorthShore University HealthSystem
Endeavor Health