Bowel Function After Minimally Invasive Urogynecologic Surgery - Full Text View

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:

MedlinePlus related topics: Bowel Movement

Drug Information available for: Docusate calcium Docusate sodium Bisacodyl Psyllium Husk Calcium polycarbophil Bismuth subsalicylate

U.S. FDA Resources

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 June 13, 2013