Optimization of Postoperative Bowel Habits
ConditionConstipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWake Forest University Health Sciences
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women ages 18 and older scheduled to undergo vaginal pelvic organ prolapse repair
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Senna Tab
Dietary supplementSenna 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
Dietary supplementDulcolax 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: SENNAExperimental treatment 1 intervention
Group B: DULCOLAXExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to Post Operative Day (POD) 5Secondary outcomes
1
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.
Time frame
Day 72
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.
Time frame
Post Operative Day (POD)1, POD2, POD3, POD4, and POD53
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').
Time frame
Baseline and Day 74
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).
Time frame
Post Operative Day (POD)1, POD2, POD3, POD4, and POD5Sponsors and contacts
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Source ClinicalTrials.gov