The Surgical Benefit and Pt.Tolerability Between Two Different Bowel Cleansing Regimens Performed Prior to Pelvic Reconstructive Surgery. Does One Bowel Cleansing Regimen Improve the Surgeons Visual Field Significantly Better Than the Other.

NCT01522261 | Unknown Phase 1

• 1 other identifier: BUA 007-2011
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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

Keywords

Mechanical Bowel Prep

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary objective of this protocol is to determine whether there is truly an advantage for the surgeon (visually) in having patients complete a Mechanical Bowel Prep prior to surgery or if an enema completed the evening before and morning of the surgery is sufficient.

  Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.

Secondary Outcomes (1)

• To evaluate whether MBP (total bowel cleansing) delays the return of bowel function and/or increases the risk of perioperative leakage of stool (fecal incontinence)post operatively.

  We will be following the subject from the day of surgery through 2 weeks post op.

Study Arms (2)

Mechanical Bowel Prep

ACTIVE COMPARATOR

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

Other: Mechanical Bowel Prep

No Mechanical Bowel Prep.

ACTIVE COMPARATOR

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

Other: No Mechanical Bowel Prep

Interventions

Mechanical Bowel Prep OTHER

Patients randomized to MBP will complete procedure per standard instructions.

Mechanical Bowel Prep

No Mechanical Bowel Prep OTHER

Patient randomized to fleets enemas only prior to surgery

No Mechanical Bowel Prep.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Urogynecology Associates: lead

Study Sites (1)

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138, United States

RECRUITING

Related Publications (1)

• Adelowo AO, Hacker MR, Modest AM, Apostolis CA, Disciullo AJ, Hanaway KJ, Elkadry EE, Rosenblatt PL, Rogers KJ, Hota LS. The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):1-7. doi: 10.1097/SPV.0000000000000346.

  PMID: 27782976 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lekha Hota, M.D.

  Boston Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 20, 2015

Record last verified: 2015-04

Locations

US (1)