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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
\*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.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
PAC-SYM
Patient assessment of constipation symptoms (PAC-SYM) is a validated 12-item questionnaire with reported average score 0-4.
Time frame: Pre-operative, 1 week post-operative, 2 weeks post-operative
PAC-QOL: Patient assessment of constipation quality of life measure
Time frame: Pre-operative, 2 weeks post-operative
Time to first bowel movement
after surgery in approximate hours/days
Time frame: 1 week post-operative
Doses of PEG used
polyethylene glycol 3350 (PEG) doses of 17 grams powder mixed in 8oz of liquid
Time frame: 1 week post-operative, 2 weeks post-operative
Rescue laxative use
Use of additional laxatives or enemas
Time frame: 1 week post-operative, 2 weeks post-operative
Satisfaction with pain after surgery
Satisfaction with pain after surgery
Time frame: 1 week post-operative
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