Bowel Function After Minimally Invasive Urogynecologic Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01044212
First received: January 5, 2010
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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 Intervention
Bowel Function
Drug: Docusate sodium
Drug: Bowel medications

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Time to first post-op bowel movement [ Time Frame: Within 1 week of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain level associated with first postoperative bowel movement [ Time Frame: Within 1 week of surgery ] [ Designated as safety issue: No ]
  • Average daily pain level in the week following surgery [ Time Frame: Within 1 week of surgery ] [ Designated as safety issue: No ]
  • Consistency of first postoperative bowel movement [ Time Frame: Within 1 week of surgery ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docusate
Docusate is the standard of care regimen
Drug: Docusate sodium
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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044212

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

No publications provided

Responsible Party: Gunhilde Buchsbaum, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT01044212     History of Changes
Other Study ID Numbers: 29359
Study First Received: January 5, 2010
Last Updated: May 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Urogynecology

Additional relevant MeSH terms:
Bismuth subsalicylate
Antidiarrheals
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014