Bowel Function After Minimally Invasive Urogynecologic Surgery

Not Applicable

Completed

• Conditions: Functional Disorder of Intestine
• Interventions: Drug: Bowel medications; Drug: Docusate

• Registration Number: NCT01044212
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

See above

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-09-14
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-21
• Last Update Submitted: 2015-09-21
• Results First Posted: 2015-10-21
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bowel medications	Bowel medications	Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
Docusate	Docusate	Docusate is the standard of care regimen

Primary Outcome Measures

Name	Time	Method
Time to First Post-op Bowel Movement	Within 1 week of surgery	The time to first post-operative bowel movement was measured in hours after surgery.

Secondary Outcome Measures

Name	Time	Method
Consistency of First Postoperative Bowel Movement	Within 1 week of surgery	The consistency of the first post-operative bowel movement was rated using the Bristol Stool Scale. This is a validated scale that is widely used. It is given to patients as a chart. The chart can be seen here: http://en.wikipedia.org/wiki/Bristol_stool_scale.; The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid
Pain Level Associated With First Postoperative Bowel Movement	Within 1 week of surgery	The pain level experienced with the first post-operative bowel movement was recorded and measured on visual analog score with range 0 to 10 in units on scale. 0 being no pain at all. 10 being worst pain.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States