Effect of Preoperative Fiber on Postoperative Bowel Function (NCT04882995) | Clinical Trial Compass
CompletedNot Applicable
Effect of Preoperative Fiber on Postoperative Bowel Function
United States84 participantsStarted 2019-05-13
Plain-language summary
Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation. The investigators are conducting this study to determine if participants who receive psyllium fiber before surgery have less difficulty with their first bowel movement after surgery.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women undergoing prolapse repair with or without hysterectomy on the University of Massachusetts urogynecology service
Exclusion Criteria:
* Unable to provide consent
* Under 18 years of age
* Pregnant women
* Prisoners
* As our validated questionnaires are only available in English, we are unable to offer study participation to Non-English speaking subjects
* Because these conditions intrinsically affect bowel function, women with the following will be excluded: history of inflammatory bowel disease, colorectal cancer, rectovaginal fistula, sigmoid resection or rectal surgery
* Because the use of motility agents can affect bowel function and stool transit, women using motility agents such as linaclotide will be excluded.
* Concurrent bowel surgery due to potential effect on the surgical field
* Concurrent anal sphincteroplasty due to potential effect on the surgical field
* Insulin-dependent diabetes mellitus with known gastroparesis as this would affect transit of fiber supplement
* Patients with a history of phenylketonuria as the psyllium fiber supplement we will be using contains phenylalanine
* History of placement of sacral neuromodulating device for indication of fecal incontinence, as this would affect bowel function
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.