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Bowel Function After Minimally Invasive Urogynecologic Surgery

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ClinicalTrials.gov Identifier: NCT01044212
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Gunhilde Buchsbaum, University of Rochester

January 5, 2010
January 7, 2010
September 14, 2012
October 21, 2015
October 21, 2015
November 2009
February 2011   (Final data collection date for primary outcome measure)
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.
Time to First Post-op Bowel Movement [ Time Frame: Within 1 week of surgery ]
Complete list of historical versions of study NCT01044212 on ClinicalTrials.gov Archive Site
  • 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

  • Pain Level Associated With First Postoperative Bowel Movement [ Time Frame: Within 1 week of surgery ]
  • Average daily pain level in the week following surgery [ Time Frame: Within 1 week of surgery ]
  • Consistency of First Postoperative Bowel Movement [ Time Frame: Within 1 week of surgery ]
Not Provided
Not Provided
 
Bowel Function After Minimally Invasive Urogynecologic Surgery
Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial
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.
See above
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Functional Disorder of Intestine
  • Drug: Docusate
    Docusate 100mg BID
    Other Name: Colace
  • 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
  • Active Comparator: Docusate
    Docusate is the standard of care regimen
    Intervention: Drug: Docusate
  • Experimental: Bowel medications
    Docusate, Miralax, Metamucil wafers, Bisacodyl suppository
    Intervention: Drug: Bowel medications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
Same as current
February 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 89 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01044212
29359
No
Not Provided
Not Provided
Gunhilde Buchsbaum, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Gunhilde Buchsbaum, MD University of Rochester
University of Rochester
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP