Effect of Preoperative Fiber on Postoperative Bowel Function

NCT04882995 | Completed Results

• 1 other identifier: H00017494
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Prolapse, Vaginal

Keywords

Postoperative constipation

Outcome Measures

Primary Outcomes (1)

• Time to First Bowel Movement After Surgery

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

  Within 7 days

Secondary Outcomes (1)

• Pain Associated With First Bowel Movement After Surgery

  Within 7 days

Study Arms (2)

Intervention - Received fiber

EXPERIMENTAL

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.

Dietary Supplement: Psyillium fiber

Control - Did not receive fiber

NO INTERVENTION

Participants did not take any preoperative fiber.

Interventions

Psyillium fiber DIETARY_SUPPLEMENT

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

Intervention - Received fiber

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing prolapse repair with or without hysterectomy on the University of Massachusetts urogynecology service

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Related Publications (6)

• 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.

  PMID: 30247168 BACKGROUND

• 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.

  PMID: 20207340 BACKGROUND

• 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.

  PMID: 22453316 BACKGROUND

• 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.

  PMID: 15902178 BACKGROUND

• 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.

  PMID: 25672646 BACKGROUND

• 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.

  PMID: 35649241 DERIVED

MeSH Terms

Conditions

Constipation; Uterine Prolapse

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical

Results Point of Contact

• Title: Dr. Deepali Maheshwari
• Organization: UMass Chan Medical School

deepali.mahesh@gmail.com

4137948764

Study Officials

• Deepali Maheshwari, DO, MPH

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: May 13, 2019
• Primary Completion: May 28, 2021
• Study Completion: June 1, 2021
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)