Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

Constipation Clinical Trial

Official title:

Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06159777
• Other study ID #: STUDY20231417
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Gabriella M Rustia, MD
• Phone: 216-202-0597
• Email: gabriella.rustia[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

1. Study team and surgeons will be blinded to group assignments, participants will not be.

2. 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Prolapse
• Prolapse; Female
• Surgical Procedure, Unspecified

Intervention

Drug:
• Polyethylene Glycol 3350
*Polyethylene glycol 3350 (PEG) will be used within it's FDA indication and dosing for constipation. Each 17-gram dose of PEG is to be mixed in 8oz of liquid.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAC-SYM	Patient assessment of constipation symptoms (PAC-SYM) is a validated 12-item questionnaire with reported average score 0-4.	Pre-operative, 1 week post-operative, 2 weeks post-operative
Secondary	PAC-QOL: Patient assessment of constipation quality of life measure		Pre-operative, 2 weeks post-operative
Secondary	Time to first bowel movement	after surgery in approximate hours/days	1 week post-operative
Secondary	Doses of PEG used	polyethylene glycol 3350 (PEG) doses of 17 grams powder mixed in 8oz of liquid	1 week post-operative, 2 weeks post-operative
Secondary	Rescue laxative use	Use of additional laxatives or enemas	1 week post-operative, 2 weeks post-operative
Secondary	Satisfaction with pain after surgery	Satisfaction with pain after surgery	1 week post-operative