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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-operative | Experimental | Participants will be instructed to take 17 grams of powder Polyethylene glycol 3350 (PEG) every day starting 3 days prior to scheduled surgery date and continue to take 17 grams of PEG every day for 7 days following the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used. |
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| Post-operative | Active Comparator | Participants will be instructed to take 17 grams of powder PEG* every day for 7 days starting the day of surgery. Participants will be allowed to titrate up or down the amount of PEG used as needed and instructed to record all doses of PEG used. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol 3350 | Drug | *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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PAC-QOL: Patient assessment of constipation quality of life measure | Pre-operative, 2 weeks post-operative | |
| Time to first bowel movement | after surgery in approximate hours/days | 1 week post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Sheyn, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| C000595212 | polyethylene glycol 3350 |
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| 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 |
| Rescue laxative use | Use of additional laxatives or enemas | 1 week post-operative, 2 weeks post-operative |
| Satisfaction with pain after surgery | Satisfaction with pain after surgery | 1 week post-operative |