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Effect of Preoperative Fiber on Postoperative Bowel Function

Primary Purpose

Constipation, Prolapse, Vaginal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psyillium fiber
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Postoperative constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts Memorial Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - Received fiber

Control - Did not receive fiber

Arm Description

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.

Participants did not take any preoperative fiber.

Outcomes

Primary Outcome Measures

Time to First Bowel Movement After Surgery
Date and time of first bowel movement captured via postoperative bowel diary

Secondary Outcome Measures

Pain Associated With First Bowel Movement After Surgery
Pain captured with visual analog scale with 0 being no pain and 10 being worst pain

Full Information

First Posted
May 6, 2021
Last Updated
June 25, 2022
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT04882995
Brief Title
Effect of Preoperative Fiber on Postoperative Bowel Function
Official Title
Effect of Preoperative Fiber on Postoperative Bowel Function
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Prolapse, Vaginal
Keywords
Postoperative constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - Received fiber
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - Did not receive fiber
Arm Type
No Intervention
Arm Description
Participants did not take any preoperative fiber.
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyillium fiber
Intervention Description
Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery
Primary Outcome Measure Information:
Title
Time to First Bowel Movement After Surgery
Description
Date and time of first bowel movement captured via postoperative bowel diary
Time Frame
Within 7 days
Secondary Outcome Measure Information:
Title
Pain Associated With First Bowel Movement After Surgery
Description
Pain captured with visual analog scale with 0 being no pain and 10 being worst pain
Time Frame
Within 7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepali Maheshwari, DO, MPH
Organizational Affiliation
UMass Chan Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30247168
Citation
Ramaseshan AS, LaSala C, O'Sullivan DM, Steinberg AC. Patient-Initiated Telephone Calls in the Postoperative Period After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Oct;26(10):626-629. doi: 10.1097/SPV.0000000000000636.
Results Reference
background
PubMed Identifier
20207340
Citation
Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.
Results Reference
background
PubMed Identifier
22453316
Citation
McNanley A, Perevich M, Glantz C, Duecy EE, Flynn MK, Buchsbaum G. Bowel function after minimally invasive urogynecologic surgery: a prospective randomized controlled trial. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):82-5. doi: 10.1097/SPV.0b013e3182455529.
Results Reference
background
PubMed Identifier
15902178
Citation
Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.
Results Reference
background
PubMed Identifier
25672646
Citation
Ballard A, Parker-Autry C, Lin CP, Markland AD, Ellington DR, Richter HE. Postoperative bowel function, symptoms, and habits in women after vaginal reconstructive surgery. Int Urogynecol J. 2015 Jun;26(6):817-21. doi: 10.1007/s00192-015-2634-8. Epub 2015 Feb 12.
Results Reference
background
PubMed Identifier
35649241
Citation
Maheshwari D, Hall CD, Jia X, Tangada A, Wu EK, Leung K, Flynn MK. The Effect of Preoperative Fiber on Postoperative Bowel Function After Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Urogynecology (Phila). 2022 Aug 1;28(8):554-560. doi: 10.1097/SPV.0000000000001203. Epub 2022 May 24.
Results Reference
derived

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Effect of Preoperative Fiber on Postoperative Bowel Function

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