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. (MBP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Boston Urogynecology Associates
Sponsor:
Information provided by (Responsible Party):
Lekha S. Hota, Boston Urogynecology Associates
ClinicalTrials.gov Identifier:
NCT01522261
First received: January 9, 2012
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Pelvic Organ Prolapse
Other: Mechanical Bowel Prep
Other: No Mechanical Bowel Prep
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)

Resource links provided by NLM:


Further study details as provided by Boston Urogynecology Associates:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: We will be following the subject from the day of surgery through 2 weeks post op. ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mechanical Bowel Prep
Patients randomized to complete a Mechanical Bowel Prep. (complete bowel cleansing) and fleet enemas prior to surgery.
Other: Mechanical Bowel Prep
Patients randomized to MBP will complete procedure per standard instructions.
Active Comparator: No Mechanical Bowel Prep.
Patients randomized to complete two fleets enemas only prior to surgery.
Other: No Mechanical Bowel Prep
Patient randomized to fleets enemas only prior to surgery

Detailed Description:

Patients will be randomized to receive a complete MBP or not prior to their surgical procedure. All patients will use 1 fleets enema the night before surgery and one the morning of surgery to ensure that the rectum is empty of all stool. This will be done since some surgeons use a rectal probe in the rectum to help with manipulation during the procedure. Stool in the rectal vault could contaminate the surgical field and lead to an infection.

Patients will be randomized at their pre-op visit and provided instructions according to the group assignment. On the day of surgery patients will be asked to complete a questionnaire in the pre-op holding area to assess their overnight symptoms including insomnia, weakness, abdominal distention, nausea, thirst and overall tolerability of the Bowel Preparation assigned.

Immediately after surgery, the primary surgeon will be asked to complete a visual analog score sheet evaluating the ease of the procedure with regard to retraction of the large and small bowel to help with visualization of the sacral promontory, retraction from posterior cul-de-sac, and maintaining adequate positioning after retraction. All surgeons (attendings, fellows, and residents) will be blinded re: the patients group assignment. Each primary surgeon will be asked to assign a final grade to the procedure as easy, medium, or difficult based on overall bowel retraction.

At their 2 week follow up visit patients will be asked to report return of bowel function (first bowel movement or flatus) in # of days after surgery and incidents of stool leakage post op.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01522261

Locations
United States, Massachusetts
Boston Urogynecology Associates Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathleen J Rogers    617-354-5452    krogers2@mah.harvard.edu   
Contact: Lekha Hota, M.D.    617-354-5452    lhota@mah.harvard.edu   
Principal Investigator: Lekha Hota, M.D.         
Sponsors and Collaborators
Boston Urogynecology Associates
Investigators
Principal Investigator: Lekha Hota, M.D. Boston Urogynecology Associates
  More Information

No publications provided

Responsible Party: Lekha S. Hota, Principal Investigator, Boston Urogynecology Associates
ClinicalTrials.gov Identifier: NCT01522261     History of Changes
Other Study ID Numbers: BUA 007-2011
Study First Received: January 9, 2012
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Urogynecology Associates:
Mechanical Bowel Prep

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2014