N/A N=84 Randomized Single-blind Treatment

Effect of Preoperative Fiber on Postoperative Bowel Function

Constipation · Prolapse, Vaginal

Bottom Line

View on ClinicalTrials.gov: NCT04882995 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Time to First Bowel Movement After Surgery — 66.5; 68.3 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Psyillium fiber (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Massachusetts, Worcester
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Bowel Movement After Surgery	66.5; 68.3	—
SECONDARY Pain Associated With First Bowel Movement After Surgery	2.0; 2.0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04882995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.