Status:
COMPLETED
Effect of Preoperative Fiber on Postoperative Bowel Function
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Constipation
Prolapse, Vaginal
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 tr...
Detailed Description
Post-operative constipation or delay in return to bowel function is a common concern among patients undergoing pelvic reconstructive surgery. A retrospective study reviewing all patient-initiated tele...
Eligibility Criteria
Inclusion
- Women undergoing prolapse repair with or without hysterectomy on the University of Massachusetts urogynecology service
Exclusion
- 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
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04882995
Start Date
May 13 2019
End Date
June 1 2021
Last Update
June 28 2022
Active Locations (1)
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1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605