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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control - Did not receive fiber | No Intervention | Participants did not take any preoperative fiber. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyillium fiber | Dietary Supplement | Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Bowel Movement After Surgery | Date and time of first bowel movement captured via postoperative bowel diary | Within 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepali Maheshwari, DO, MPH | UMass Chan Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30247168 | Background | 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. | |
| 20207340 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control - Did Not Receive Fiber | Participants did not take any preoperative fiber. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control - Did Not Receive Fiber |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Bowel Movement After Surgery | Date and time of first bowel movement captured via postoperative bowel diary | Posted | Mean | Standard Deviation | hours | Within 7 days |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deepali Maheshwari | UMass Chan Medical School | 4137948764 | deepali.mahesh@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2021 | Jun 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
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| 22453316 | 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. |
| 15902178 | 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. |
| 25672646 | 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. |
| 35649241 | Derived | 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. |
| Surgery postponed due to COVID |
|
Participants did not take any preoperative fiber.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PAC-SYM | The Patient Assessment of Constipation Symptoms (PAC-SYM) is a validated questionnaire that asks about patient's constipation symptoms. Scores range from 0-48 with lower scores associated with fewer symptoms and higher scores associated with more symptoms | Mean | Full Range | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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 | Posted | Median | Full Range | score on a scale | Within 7 days |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control - Did Not Receive Fiber | Participants did not take any preoperative fiber. | 0 | 36 | 0 | 36 | 0 | 36 |
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| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |