Status:

COMPLETED

Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Lead Sponsor:

Halina M Zyczynski, MD

Conditions:

Pelvic Organ Prolapse

Prolapse

Eligibility:

FEMALE

18+ years

Phase:

PHASE4

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 bow...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

February 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2017

Estimated Enrollment :

95 Patients enrolled

Trial Details

Trial ID

NCT01805310

Start Date

February 1 2013

End Date

August 1 2017

Last Update

January 9 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213