Clinical trial NCT06159777: Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
Official title: Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Constipation
Surgical Procedure, Unspecified
Prolapse; Female
Keywords: postoperative constipation
minimally invasive surgery
apical prolapse
prolapse
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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)

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

Primary outcomes:
measure: PAC-SYM
timeFrame: Pre-operative, 1 week post-operative, 2 weeks post-operative
Secondary outcomes:
measure: PAC-QOL: Patient assessment of constipation quality of life measure
timeFrame: Pre-operative, 2 weeks post-operative
measure: Time to first bowel movement
timeFrame: 1 week post-operative
measure: Doses of PEG used
timeFrame: 1 week post-operative, 2 weeks post-operative
measure: Rescue laxative use
timeFrame: 1 week post-operative, 2 weeks post-operative
measure: Satisfaction with pain after surgery
timeFrame: 1 week post-operative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References: