Skip to main content
OpenTrials
Completed

NCT Number: NCT04882995

Effect of Preoperative Fiber on Postoperative Bowel Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

About this study

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 telephone calls in the postoperative period after pelvic reconstructive surgery found the most frequent concern among patients to be constipation. Moreover, prevention of constipation may help minimize unnecessary pressure and strain on the pelvic floor during post-operative recovery.

There are various strategies for managing post-operative constipation which typically involve medications including stool softeners, laxatives, or stool bulking agents. Several studies have examined the use of these postoperative regimens and have found a shortened time to first bowel movement (BM) with a combination of these medications when compared to placebo.Despite the use of these regimens, most patients do not have their first BM until the second or third postoperative day and this can result in significant distress, discomfort, and fecal impaction.

Postoperative constipation is a multifactorial process and an alternative approach involves consideration of the preoperative period. Preoperative defecation patterns can be a factor in the development of postoperative constipation. We are not aware of any studies looking at the effect of preoperative intervention on postoperative bowel function, particularly the use of preoperative fiber supplementation.

Psyllium fiber is a dietary supplement and stool bulking agent that stimulates peristalsis and improves bowel evacuation. The Western diet is low in fiber and women with pelvic organ prolapse have been found to have lower dietary intake of fiber when compared to controls.8 The primary objective of this study is to evaluate whether the use of preoperative psyllium fiber intake reduces time to first bowel movement after pelvic reconstructive surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psyillium fiber

Dietary Supplement

Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery

Primary outcomes

  1. Time to First Bowel Movement After Surgery

    Time frame: Within 7 days

    Date and time of first bowel movement captured via postoperative bowel diary

Secondary outcomes

  1. Pain Associated With First Bowel Movement After Surgery

    Time frame: Within 7 days

    Pain captured with visual analog scale with 0 being no pain and 10 being worst pain

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 12, 2021
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.