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Effect of Preoperative Fiber on Postoperative Bowel Function

Effect of Preoperative Fiber on Postoperative Bowel Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04882995
Enrollment
84
Registered
2021-05-12
Start date
2019-05-13
Completion date
2021-06-01
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Prolapse, Vaginal

Keywords

Postoperative constipation

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.

Interventions

DIETARY_SUPPLEMENTPsyillium fiber

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

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to First Bowel Movement After SurgeryWithin 7 daysDate and time of first bowel movement captured via postoperative bowel diary

Secondary

MeasureTime frameDescription
Pain Associated With First Bowel Movement After SurgeryWithin 7 daysPain captured with visual analog scale with 0 being no pain and 10 being worst pain

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
35
Control - Did Not Receive Fiber
Participants did not take any preoperative fiber.
36
Total71

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation44
Overall StudySurgery postponed due to COVID11
Overall StudyWithdrawal by Subject12

Baseline characteristics

CharacteristicIntervention - Received FiberControl - Did Not Receive FiberTotal
Age, Continuous60.7 years
STANDARD_DEVIATION 11.9
60 years
STANDARD_DEVIATION 10.3
60.3 years
STANDARD_DEVIATION 11
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants3 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants33 Participants66 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
PAC-SYM0.5 units on a scale0.3 units on a scale0.3 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants2 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants5 Participants
Race (NIH/OMB)
White
32 Participants31 Participants63 Participants
Sex: Female, Male
Female
35 Participants36 Participants71 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 36
other
Total, other adverse events
0 / 350 / 36
serious
Total, serious adverse events
0 / 350 / 36

Outcome results

Primary

Time to First Bowel Movement After Surgery

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

Time frame: Within 7 days

ArmMeasureValue (MEAN)Dispersion
Intervention - Received FiberTime to First Bowel Movement After Surgery66.5 hoursStandard Deviation 22.7
Control - Did Not Receive FiberTime to First Bowel Movement After Surgery68.3 hoursStandard Deviation 25
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

Time frame: Within 7 days

ArmMeasureValue (MEDIAN)
Intervention - Received FiberPain Associated With First Bowel Movement After Surgery2.0 score on a scale
Control - Did Not Receive FiberPain Associated With First Bowel Movement After Surgery2.0 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026