University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
NCT Number: NCT06159777
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.
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Notify Me18 year–89 year
Female
Interventional
Phase 4
Cleveland, Ohio, 44106, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
*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.
Other names: Miralax
Time frame: Pre-operative, 1 week post-operative, 2 weeks post-operative
Patient assessment of constipation symptoms (PAC-SYM) is a validated 12-item questionnaire with reported average score 0-4.
Time frame: Pre-operative, 2 weeks post-operative
Time frame: 1 week post-operative
after surgery in approximate hours/days
Time frame: 1 week post-operative, 2 weeks post-operative
polyethylene glycol 3350 (PEG) doses of 17 grams powder mixed in 8oz of liquid
Time frame: 1 week post-operative, 2 weeks post-operative
Use of additional laxatives or enemas
Time frame: 1 week post-operative
Satisfaction with pain after surgery
University Hospitals Cleveland Medical Center
Other
Pre- and Post-operative Compared to Post-operative Only Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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