Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether taking a laxative called polyethylene glycol 3350 before surgery helps reduce discomfort during bowel movements after surgery for women having procedures to fix pelvic prolapse. The main goal is to see if using the laxative before surgery makes it easier for patients to have bowel movements compared to only starting it after the surgery. Women aged 18 and older, who are planning to undergo specific minimally invasive urogynecologic surgeries, may be eligible to participate.

If you join the trial, you’ll complete some questionnaires about your bowel movements before and after the surgery. This will help researchers understand if pre-operative laxative use improves your experience. It's important to know that women with certain bowel conditions or who have had specific surgeries related to bowel issues are not eligible for this study. Overall, this trial aims to improve comfort and recovery for women undergoing these types of surgeries.

Gender

FEMALE

Eligibility 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