Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06335797

Optimization of Postoperative Bowel Habits

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
88 (estimated)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTSenna TabSenna 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 SuppositoriesDulcolax 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.

Timeline

Start date
2024-10-16
Primary completion
2027-05-01
Completion
2027-05-01
First posted
2024-03-28
Last updated
2026-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06335797. Inclusion in this directory is not an endorsement.