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Bowel Function After Minimally Invasive Urogynecologic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01044212
First Posted: January 7, 2010
Last Update Posted: October 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gunhilde Buchsbaum, University of Rochester
  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
Functional Disorder of Intestine Drug: Docusate Drug: Bowel medications

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gunhilde Buchsbaum, University of Rochester:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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



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
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

Detailed Description:
See above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gunhilde Buchsbaum, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01044212     History of Changes
Other Study ID Numbers: 29359
First Submitted: January 5, 2010
First Posted: January 7, 2010
Results First Submitted: September 14, 2012
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
Bismuth subsalicylate
Antidiarrheals
Gastrointestinal Agents