N/A
N=72
Bowel Function After Minimally Invasive Urogynecologic Surgery
Functional Disorder of Intestine
Bottom Line
View on ClinicalTrials.gov: NCT01044212 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Time to First Post-op Bowel Movement — 64; 77 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Docusate (Drug); Bowel medications (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Rochester
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Post-op Bowel Movement |
64; 77 | — |
| SECONDARY Pain Level Associated With First Postoperative Bowel Movement |
3.6; 3.7 | — |
| SECONDARY Consistency of First Postoperative Bowel Movement |
3.13; 3.40 | — |
Summary
The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
Eligibility Criteria
Inclusion Criteria
- Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.
Procedures may include:
- robot-assisted laparoscopic sacrocolpopexy
- sacrospinous ligament suspension
- uterosacral ligament suspension/paravaginal defect repair
- colpocleisis
- cystocele repair
Additional procedures may include:
- hysterectomy
- adnexectomy
- culdoplasty
- minimally invasive sling procedure (TVT or TOT)
- periurethral collagen injections
- enterocele repair
Exclusion Criteria
- Planning to undergo laparotomy.
- Undergoing rectocele or perineocele repair as part of surgery.
- Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
- Presence of a colostomy.
- Chronic kidney disease
- Insulin-dependent diabetes mellitus
- Known cardiac disease
- Gastric ulcers
- Difficulty swallowing or esophageal stricture
- Persistent nausea and vomiting
- Signs and symptoms consistent with bowel obstruction
Data sourced from ClinicalTrials.gov (NCT01044212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.