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Trial record 1 of 2 for:    sacral colpopexy | pittsburgh, Pennsylvania, U.S.
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Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

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.
 
ClinicalTrials.gov Identifier: NCT01805310
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Halina M Zyczynski, MD, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 1, 2013
First Posted Date  ICMJE March 6, 2013
Last Update Posted Date January 9, 2018
Study Start Date  ICMJE February 2013
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
PAC-SYM [ Time Frame: 1 year ]
Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • Surgeon perception of bowel preparation [ Time Frame: 1 year ]
    Immediately after completing the surgical case, surgeons will complete a 13-item surgeon questionnaire assessing degree of surgical difficulty and how it relates to the bowel. Operative time and consultations will also be recorded as objective measures of surgical difficulty.
  • Return of normal bowel function [ Time Frame: 1 year ]
    A seven-day bowel diary will be obtained at baseline and in the first week after surgery. This log will include daily assessment of bowel frequency, type of bowel movement using the validated Bristol stool scale, degree of straining, and used of narcotics or laxatives.
  • Perioperative complications [ Time Frame: 1 year ]
    Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Official Title  ICMJE Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Brief Summary

Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations.

Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations.

This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Organ Prolapse
  • Prolapse
Intervention  ICMJE
  • Other: Bowel preparation
    Subjects randomized to the mechanical bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one.
    Other Name: Magnesium citrate
  • Other: No bowel preparation
    Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
Study Arms  ICMJE
  • Bowel Preparation
    Women randomized to the bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one. They will also be placed on a clear liquid diet on preoperative day number one.
    Intervention: Other: Bowel preparation
  • No bowel preparation
    Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
    Intervention: Other: No bowel preparation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2018)
95
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2013)
120
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • Age ≥ 18 years
  • Planned laparoscopic or robotic-assisted sacral colpopexy

Exclusion Criteria:

  • History of ulcerative colitis or Crohn's disease
  • Prior large or small bowel resection
  • Known diagnosis of gastroparesis
  • Prior pelvic radiation
  • History of abdominal or pelvic malignancy
  • Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair
  • Pregnancy
  • Known allergic reactions to components of the study products
  • Known renal insufficiency
  • Non-English speaking as the primary study questionnaires are all currently in English only
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01805310
Other Study ID Numbers  ICMJE PRO12020453
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Halina M Zyczynski, MD, University of Pittsburgh
Study Sponsor  ICMJE Halina M Zyczynski, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kelly L Kantartzis, MD University of Pittsburgh
Principal Investigator: Halina M Zyczynski, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2018

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