Effect of Preoperative Fiber on Postoperative Bowel Function

Not Applicable

Completed

Conditions: Prolapse, Vaginal
Constipation

Interventions: Dietary Supplement: Psyillium fiber

Registration Number: NCT04882995

Lead Sponsor: University of Massachusetts, Worcester

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 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.

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 84

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention - Received fiber	Psyillium fiber	Participants received 14 doses of psyllium fiber packet (Metamucil, 3.4g). They were instructed to take 1 packet twice a day beginning 7 days before surgery.

Primary Outcome Measures

Name	Time	Method
Time to First Bowel Movement After Surgery	Within 7 days	Date and time of first bowel movement captured via postoperative bowel diary

Secondary Outcome Measures

Name	Time	Method
Pain Associated With First Bowel Movement After Surgery	Within 7 days	Pain captured with visual analog scale with 0 being no pain and 10 being worst pain