Optimization of Postoperative Bowel Habits

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335797
• Other study ID #: IRB00110733
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Christina M Mezes, MD
• Phone: 336-713-4098
• Email: cmezes[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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