Recruiting
Phase 1

Bowel Cleansing

Sponsor:

Boston Urogynecology Associates

Code:

NCT01522261

Conditions

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mechanical Bowel Prep

No Mechanical Bowel Prep

Study Details

Brief summary:

Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery?

Conditions

Pelvic Organ Prolapse

Study ID

NCT01522261

Start date

Jan, 2012

Status verified date

Apr, 2015

Completion date

Jan, 2017

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:

  • Laparoscopic sacrocervicopexy
  • Laparoscopic sacrocolpopexy
  • Laparoscopic sacrohysteropexy
  • Laparoscopic uterosacral ligament suspension

Who understand and are willing to comply with the study requirements, including agreeing to answer the preoperative and postoperative questionnaires

Exclusion Criteria:

  • Previous abdominal or laparoscopic colon surgery (not including transrectal procedures)
  • History of abdominal malignancy
  • History of surgical debulking for previous malignancy
  • Non-english speaking
  • Pregnancy
  • Hx of abdomino-pelvic radiation
  • Contraindications to Sodium Phosphate
  • Contraindications to laparoscopic surgery

Study Design

Enrollment

176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

active comparator: Mechanical Bowel Prep

Patients randomized to complete a Mechanical Bowel Prep. (complete bowel cleansing) and fleet enemas prior to surgery.

active comparator: No Mechanical Bowel Prep.

Patients randomized to complete two fleets enemas only prior to surgery.

Interventions

Mechanical Bowel Prep

Patients randomized to MBP will complete procedure per standard instructions.

No Mechanical Bowel Prep

Patient randomized to fleets enemas only prior to surgery

Primary outcome measure

  • To determine whether there is there an added benefit in using a MBP with regard to positioning of the large and small bowel for exposure of key anatomic structures during pelvic reconstructive surgical procedures. [ Time Frame: Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op. ]

Central Contacts and Locations

Locations

Boston Urogynecology Associates

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Kathleen J Rogers

617-354-5452krogers2@mah.harvard.edu

Lekha Hota, M.D.

617-354-5452lhota@mah.harvard.edu

Principal Investigator:

Lekha Hota, M.D.

More Information

Sponsor

Boston Urogynecology Associates

Last update posted

Apr 20, 2015

Last verified

Apr, 2015

Keywords

  • Mechanical Bowel Prep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Urogynecology Associates on 2015-04-20.