Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- PAC-SYM
研究概览
简要总结
The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation.
The main question it aims to answer is: Does use of a laxative before surgery lessen the discomfort of bowel movements after surgery? Participants will be asked to complete questionnaires before and after surgery. Researchers will compare using the laxative before and after surgery versus only after surgery to see if there is less discomfort with bowel movements after surgery.
详细描述
The purpose of this study is to evaluate if there is a difference in bother related to constipation between a pre-operative versus post-operative start of a bowel regimen for patients undergoing surgery for pelvic organ prolapse This will be a multi-institution, single-blind, randomized control trial utilizing questionnaires and chart review to evaluate effect of pre-operative bowel regimen on post-operative constipation.
- Study team and surgeons will be blinded to group assignments, participants will not be.
- Participants will be randomized after consent is obtained, and at least 1 week prior to planned surgery, via computer-generated blocks in a 1:1 ratio between study group (pre-operative and post-operative use) and control group (post-operative only use) of polyethylene glycol 3350 (PEG)
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients assigned female sex at birth undergoing an apical prolapse procedure including: sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, or colpocleisis. Planned urogynecologic procedure may include hysterectomy, adnexectomy, colporrhaphy, perineorrhaphy, or treatment of stress urinary incontinence.
- •Planning to undergo primary procedure as above via minimally invasive route: vaginal or laparoscopic (including robotic-assisted). Including those that have an unplanned conversion intraoperatively of minimally invasive route to open laparotomy.
排除标准
- •Diagnosis of irritable bowel syndrome, inflammatory bowel disease, slow transit constipation, obstructed defecation, or symptomatic constipation at time of study screening and recruitment. (Slow transit constipation and obstructed defecation defined as per American Gastroenterological Association 2013 constipation statement. Symptomatic constipation defined as any of the following: Bristol Stool Scale score of 1 or 2, PAC-SYM score greater than 1.0, self-reported 2 or less bowel movements per week.)
- •Current use of pharmacologic laxative agent ≥1x/week (prescription or OTC) for the treatment of constipation symptoms
- •Allergy or intolerance to polyethylene glycol 3350
- •Planning to undergo surgery via laparotomy
- •Scheduled for any concurrent non-urogynecologic procedure, ex abdominoplasty
- •History of large bowel resection, surgical treatment of constipation, or anal sphincter surgery
- •History of sacral neuromodulation
- •Current or prior radiation therapy to the abdomen or pelvis
- •Current or prior diagnosis of malignancy
- •Unable to provide informed consent
研究组 & 干预措施
Pre-operative
Participants will be instructed to take 17 grams of powder Polyethylene glycol 3350 (PEG) every day starting 3 days prior to scheduled surgery date and continue to take 17 grams of PEG every day for 7 days following the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used.
干预措施: Polyethylene Glycol 3350 (Drug)
Post-operative
Participants will be instructed to take 17 grams of powder PEG* every day for 7 days starting the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used.
干预措施: Polyethylene Glycol 3350 (Drug)
结局指标
主要结局
PAC-SYM
时间窗: Pre-operative, 1 week post-operative, 2 weeks post-operative
Patient assessment of constipation symptoms (PAC-SYM) is a validated 12-item questionnaire with reported average score 0-4.
次要结局
- PAC-QOL: Patient assessment of constipation quality of life measure(Pre-operative, 2 weeks post-operative)
- Time to first bowel movement(1 week post-operative)
- Doses of PEG used(1 week post-operative, 2 weeks post-operative)
- Rescue laxative use(1 week post-operative, 2 weeks post-operative)
- Satisfaction with pain after surgery(1 week post-operative)
研究者
David Sheyn
Associate professor
University Hospitals Cleveland Medical Center