Clinical trial NCT04882995: Effect of Preoperative Fiber on Postoperative Bowel Function
Official title: Effect of Preoperative Fiber on Postoperative Bowel Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Prolapse, Vaginal
Keywords: Postoperative constipation
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to First Bowel Movement After Surgery
timeFrame: Within 7 days
Secondary outcomes:
measure: Pain Associated With First Bowel Movement After Surgery
timeFrame: Within 7 days
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Deepali Maheshwari, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.