Bowel Function After Minimally Invasive Urogynecologic Surgery

Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Functional Disorder of Intestine
• Intervention / Treatment: Drug: Docusate; Drug: Bowel medications

Detailed Description

See above

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Docusate; Docusate is the standard of care regimen	Drug: Docusate; Docusate 100mg BID; Other Names: Colace
Experimental: Bowel medications; Docusate, Miralax, Metamucil wafers, Bisacodyl suppository	Drug: Bowel medications; Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID; Other Names: Dulcolax; Polyethylene glycol; Colace; Psyllium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Associated With First Postoperative Bowel Movement	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.	Within 1 week of surgery
Consistency of First Postoperative Bowel Movement	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	Within 1 week of surgery

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Gunhilde Buchsbaum, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Urogynecology
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Gastrointestinal Agents; Cathartics; Antidiarrheals; Bismuth subsalicylate; Psyllium
• Other Study ID Numbers: 29359