Effect of Preoperative Fiber on Postoperative Bowel Function

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Constipation Prolapse, Vaginal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention - Received 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.

Group Type EXPERIMENTAL

Psyillium fiber

Intervention Type DIETARY_SUPPLEMENT

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

Control - Did not receive fiber

Participants did not take any preoperative fiber.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psyillium fiber

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes