Bowel Function After Minimally Invasive Urogynecologic Surgery

NCT01044212 | Completed Results

• 1 other identifier: 29359
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Disorder of Intestine

Keywords

Urogynecology

Outcome Measures

Primary Outcomes (1)

• Time to First Post-op Bowel Movement

  The time to first post-operative bowel movement was measured in hours after surgery.

  Within 1 week of surgery

Secondary Outcomes (2)

• Pain Level Associated With First Postoperative Bowel Movement

  Within 1 week of surgery

• Consistency of First Postoperative Bowel Movement

  Within 1 week of surgery

Study Arms (2)

Docusate

ACTIVE COMPARATOR

Docusate is the standard of care regimen

Drug: Docusate

Bowel medications

EXPERIMENTAL

Docusate, Miralax, Metamucil wafers, Bisacodyl suppository

Drug: Bowel medications

Interventions

Docusate DRUG

Docusate 100mg BID

Also known as: Colace

Docusate

Bowel medications DRUG

Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID

Also known as: Colace, Psyllium, Polyethylene glycol, Dulcolax

Bowel medications

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Dioctyl Sulfosuccinic Acid; Psyllium; Polyethylene Glycols; Bisacodyl

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Ethylene Glycols; Glycols; Alcohols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Gunhilde Buchsbaum, Division Director Urogynecology
• Organization: University of Rochester

gunhilde_buchsbaum@urmc.rochester.edu

585-273-3233

Study Officials

• Gunhilde Buchsbaum, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 7, 2010
• Study Start: November 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 21, 2015
• Results First Posted: October 21, 2015

Record last verified: 2015-09

Locations

US (1)