Optimization of Postoperative Bowel Habits

Optimization of Postoperative Bowel Habits Following Pelvic Reconstructive Surgery: a Randomized Controlled Trial

Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Senna Tab; Dietary supplement: Dulcolax Suppositories

Detailed Description

Delayed return to bowel function following vaginal surgery for pelvic organ prolapse has been deemed to be highly distressing for patients, and is ranked as one of the most common reasons for emergency department visits and telephone calls in the immediate post-operative period.

Despite the prevalence of constipation and significant effect on quality of life, few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population.

As per available medical literature, the onset of action for oral senna occurs within 6-12 hours, while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration. Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sachin N Vyas, MS, PhD; Phone Number: 336-713-4098; Email: svyas@wakehealth.edu
• Study Contact Backup: Name: Christina M Mezes, MD; Phone Number: 336-713-4098; Email: cmezes@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Contact: Christina M Mezes, MD; Phone Number: 336-713-4098; Email: cmezes@wakehealth.edu
      • Contact: Sachin N Vyas, MS, PhD; Phone Number: 336.713.4098; Email: svyas@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women ages 18 and older scheduled to undergo vaginal pelvic organ prolapse repair

Exclusion Criteria:

• Women younger than 18 years old
• Those unable to provide consent
• Preexisting chronic laxative use
• Conditions that could affect bowel function including, inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, rectovaginal fistula; concurrent bowel surgery; intraoperative bowel injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SENNA; Group A participants will be prescribed oral senna (Senokot; Atlantis Consumer Healthcare Inc., Bridgewater, NJ) 8.6mg tablets and be instructed to start with two tablets on the morning of Post Operative Day (POD)#1. Participant will continue taking two tablets on the daily. If no bowel movement on the morning of POD#3 participant may take 2 tablets in the morning and another 2 tablets that evening. The same can be replicated on POD#4. If no bowel movement on the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the urology clinic for further instruction.	Dietary supplement: Senna Tab; Senna 8.6mg two tablets per day post operative day 1 and and if needed, then continue on the same dose regiment until post operative day 5.; Other Names: Senokot
Experimental: DULCOLAX; Group B participants will be prescribed bisacodyl rectal (Dulcolax Suppository; Sanofi S.A., Paris, France) 1 suppository to be placed rectally on the morning of Post Operative Day (POD)#1. Participant will continue placing a nightly rectal suppository until their first bowel movement. If no bowel movement by the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the clinic for further instruction.	Dietary supplement: Dulcolax Suppositories; Dulcolax 1 suppository to be placed rectally on the evening of post operative day 1 and if needed, then continue using the same dose regiment until the post operative day 5.; Other Names: Bisacodyl Suppositories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in hours to first bowel movement comparison between the two arms	To compare the time to first bowel movement after use of bisacodyl suppositories or oral senna in women undergoing vaginal reconstructive surgery for pelvic organ prolapse. Time in hours will be recorded from the end of the surgical procedure. That is Post Operative Day (POD) 0. First bowel movement will be recorded up to POD5.	up to Post Operative Day (POD) 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Overall Satisfaction (TSQM) Scores	Patients will complete the Treatment Satisfaction Questionnaire for Medicine (TSQM) at 1 week postop. The TSQM is a validated survey assessing patient satisfaction to treatment - It consists of 14 questions, with 7 possible answers for each question, ranging from "extremely agree" to extremely disagree. Higher Scores meaning more satisfaction.	Day 7
Visual Analog Scale (VAS) Pain Scores	Patients will be asked to rate their pain with first bowel movement using an 11-point visual analog scale (VAS), in which a score of 0 equates to "no pain" and a score of 10 equates to the "worst pain possible." - VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.	Post Operative Day (POD)1, POD2, POD3, POD4, and POD5
Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores	The Patient Assessment of Constipation Symptom Questionnaire is a validated 12-item questionnaire based on the Rome criteria for constipation and is tailored to assess a change in short-term constipation symptoms after an intervention. A score of 0.35 or greater on the Patient Assessment of Constipation Symptom Questionnaire is consistent with constipation, and the changes in scores correlate with clinical changes in constipation symptoms. Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe').	Baseline and Day 7
Bristol Stool Form Scale (BSFS) Scores	The Bristol Stool Form Scale (BSFS) is a visual bowel movement rating scale from 1 to 7 that provided a validated measure of gut transit time based on the shape, consistency, and appearance of the bowel movement. The BSFS is an ordinal scale of stool types ranging from the hardest (type 1) to the softest (type 7) that is widely used in practice and clinical research to measure stool form. Types 1 and 2 are considered abnormally hard stools (and in conjunction with other symptoms indicative of constipation).	Post Operative Day (POD)1, POD2, POD3, POD4, and POD5

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Candace Parker-Autry, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• Caljouw MA, Hogendorf-Burgers ME. GYNOTEL: telephone advice to gynaecological surgical patients after discharge. J Clin Nurs. 2010 Dec;19(23-24):3301-6. doi: 10.1111/j.1365-2702.2010.03395.x. Epub 2010 Oct 14.
• 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.
• Tarumi Y, Wilson MP, Szafran O, Spooner GR. Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. J Pain Symptom Manage. 2013 Jan;45(1):2-13. doi: 10.1016/j.jpainsymman.2012.02.008. Epub 2012 Aug 11.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Laxatives; Bowel Habits; Pelvic Surgery
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Cathartics; Laxatives; Bisacodyl
• Other Study ID Numbers: IRB00110733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes