Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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