Bowel Function After Minimally Invasive Urogynecologic Surgery

Overview

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.

Full Title of Study: “Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2011

Detailed Description

See above

Interventions

  • Drug: Docusate
    • Docusate 100mg BID
  • Drug: Bowel medications
    • Docusate 100mg BID Metamucil fiber wafers – 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID

Arms, Groups and Cohorts

  • Active Comparator: Docusate
    • Docusate is the standard of care regimen
  • Experimental: Bowel medications
    • Docusate, Miralax, Metamucil wafers, Bisacodyl suppository

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Rochester
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gunhilde Buchsbaum, Professor – University of Rochester
  • Overall Official(s)
    • Gunhilde Buchsbaum, MD, Principal Investigator, University of Rochester

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