Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Kelly Kantartzis, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01805310
First received: March 1, 2013
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Pelvic Organ Prolapse
Prolapse
Other: Bowel preparation
Other: No bowel preparation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • PAC-SYM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Surgeon perception of bowel preparation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions.


Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No bowel preparation
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
Other: No bowel preparation
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805310

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kelly L Kantartzis, MD    412-641-1440    gerschultzkl@upmc.edu   
Contact: Halina M Zyczynski, MD    412-641-1440    zyczhm@mail.magee.edu   
Principal Investigator: Kelly L Kantartzis, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Kelly L Kantartzis, MD University of Pittsburgh
Principal Investigator: Halina M Zyczynski, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Kelly Kantartzis, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01805310     History of Changes
Other Study ID Numbers: PRO12020453
Study First Received: March 1, 2013
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pelvic organ prolapse
Prolapse
Cathartics
Mechanical bowel preparation

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Magnesium citrate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014