Bowel Function After Minimally Invasive Urogynecologic Surgery

• ClinicalTrials.gov Identifier: NCT01044212
• Recruitment Status: Completed
• First Posted: January 7, 2010
• Results First Posted: October 21, 2015
• Last Update Posted: October 21, 2015
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Gunhilde Buchsbaum, University of Rochester

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Functional Disorder of Intestine	Drug: Docusate; Drug: Bowel medications	Not Applicable

Detailed Description:

See above

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial
• Study Start Date: November 2009
• Actual Primary Completion Date: February 2011
• Actual Study Completion Date: February 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Docusate; Docusate is the standard of care regimen	Drug: Docusate; Docusate 100mg BID; Other Name: 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: Colace; Psyllium; Polyethylene glycol; Dulcolax

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Pain Level Associated With First Postoperative Bowel Movement [ Time Frame: 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.
2. Consistency of First Postoperative Bowel Movement [ Time Frame: 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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, New York

University of Rochester

Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

• Principal Investigator: Gunhilde Buchsbaum, MD; University of Rochester

More Information

• Responsible Party: Gunhilde Buchsbaum, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01044212
• Other Study ID Numbers: 29359
• First Posted: January 7, 2010
• Results First Posted: October 21, 2015
• Last Update Posted: October 21, 2015
• Last Verified: September 2015

Keywords provided by Gunhilde Buchsbaum, University of Rochester:

Urogynecology

Additional relevant MeSH terms:

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Psyllium; Bismuth subsalicylate; Cathartics; Gastrointestinal Agents; Antidiarrheals