Optimizing bowel habits after pelvic surgery
Optimization of Postoperative Bowel Habits Following Pelvic Reconstructive Surgery: a Randomized Controlled Trial
NA · Wake Forest University Health Sciences · NCT06335797
This study tests whether taking oral senna or using rectal bisacodyl suppositories can help women who have had vaginal surgery for pelvic organ prolapse avoid constipation after their surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06335797 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of two different bowel regimens for women undergoing vaginal surgery for pelvic organ prolapse. Participants will be randomly assigned to receive either oral senna or rectal bisacodyl suppositories to prevent postoperative constipation. The study aims to address the common issue of delayed bowel function after surgery, which can lead to distress and emergency visits. By comparing the onset of action and effectiveness of these two treatments, the trial seeks to establish an evidence-based approach to managing postoperative bowel habits.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are scheduled for vaginal pelvic organ prolapse repair.
Not a fit: Patients who may not benefit include those with preexisting chronic laxative use or conditions affecting bowel function, such as inflammatory bowel disease or colorectal cancer.
Why it matters
Potential benefit: If successful, this study could significantly improve postoperative recovery and quality of life for women undergoing pelvic surgery by effectively managing constipation.
How similar studies have performed: While few studies have focused specifically on postoperative constipation in the Urogynecology population, the approach of comparing different laxative regimens has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Candace Parker-Autry, MD — Wake Forest University Health Sciences
- Study coordinator: Christina M Mezes, MD
- Email: cmezes@wakehealth.edu
- Phone: 336-713-4098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Constipation, Bowel Habits, Pelvic Surgery, Laxatives