Constipation, Prolapse, Vaginal
Conditions
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
Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Bowel Movement After Surgery | Within 7 days | Date and time of first bowel movement captured via postoperative bowel diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Associated With First Bowel Movement After Surgery | Within 7 days | Pain captured with visual analog scale with 0 being no pain and 10 being worst pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 4 |
| Overall Study | Surgery postponed due to COVID | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Intervention - Received Fiber | Control - Did Not Receive Fiber | Total |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 11.9 | 60 years STANDARD_DEVIATION 10.3 | 60.3 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 33 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PAC-SYM | 0.5 units on a scale | 0.3 units on a scale | 0.3 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 32 Participants | 31 Participants | 63 Participants |
| Sex: Female, Male Female | 35 Participants | 36 Participants | 71 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 36 |
| other Total, other adverse events | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 |
Outcome results
Time to First Bowel Movement After Surgery
Date and time of first bowel movement captured via postoperative bowel diary
Time frame: Within 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention - Received Fiber | Time to First Bowel Movement After Surgery | 66.5 hours | Standard Deviation 22.7 |
| Control - Did Not Receive Fiber | Time to First Bowel Movement After Surgery | 68.3 hours | Standard Deviation 25 |
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention - Received Fiber | Pain Associated With First Bowel Movement After Surgery | 2.0 score on a scale |
| Control - Did Not Receive Fiber | Pain Associated With First Bowel Movement After Surgery | 2.0 score on a scale |