Effect of Preoperative Fiber on Postoperative Bowel Function

Constipation Clinical Trial

Official title:

Effect of Preoperative Fiber on Postoperative Bowel Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882995
• Other study ID #: H00017494
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 1, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Prolapse
• Prolapse, Vaginal
• Uterine Prolapse

Intervention

Dietary Supplement:
• Psyillium fiber
Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery

Locations

Country	Name	City	State
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Bowel Movement After Surgery	Date and time of first bowel movement captured via postoperative bowel diary	Within 7 days
Secondary	Pain Associated With First Bowel Movement After Surgery	Pain captured with visual analog scale with 0 being no pain and 10 being worst pain	Within 7 days