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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014