Constipation
Conditions
Keywords
Bowel Habits, Pelvic Surgery, Laxatives
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTSenna 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.
DIETARY_SUPPLEMENTDulcolax 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in hours to first bowel movement comparison between the two arms | up to Post Operative Day (POD) 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Satisfaction (TSQM) Scores | Day 7 | 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. |
| Visual Analog Scale (VAS) Pain Scores | Post Operative Day (POD)1, POD2, POD3, POD4, and POD5 | 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. |
| Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores | Baseline and Day 7 | 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'). |
| Bristol Stool Form Scale (BSFS) Scores | Post Operative Day (POD)1, POD2, POD3, POD4, and POD5 | 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). |
Countries
United States
Contacts
CONTACTChristina M Mezes, MD
CONTACTSachin N Vyas, MS, PhD
PRINCIPAL_INVESTIGATORCandace Parker-Autry, MD
Wake Forest University Health Sciences
Outcome results
None listed