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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522261
Recruitment Status : Unknown
Verified April 2015 by Lekha S. Hota, Boston Urogynecology Associates.
Recruitment status was:  Recruiting
First Posted : January 31, 2012
Last Update Posted : April 20, 2015
Information provided by (Responsible Party):
Lekha S. Hota, Boston Urogynecology Associates

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

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: Mechanical Bowel Prep Other: No Mechanical Bowel Prep Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Official Title: The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)
Study Start Date : January 2012
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  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. [ Time Frame: Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op. ]
    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 :
  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. [ Time Frame: We will be following the subject from the day of surgery through 2 weeks post op. ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01522261

United States, Massachusetts
Boston Urogynecology Associates Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathleen J Rogers    617-354-5452   
Contact: Lekha Hota, M.D.    617-354-5452   
Principal Investigator: Lekha Hota, M.D.         
Sponsors and Collaborators
Boston Urogynecology Associates
Principal Investigator: Lekha Hota, M.D. Boston Urogynecology Associates

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lekha S. Hota, Principal Investigator, Boston Urogynecology Associates Identifier: NCT01522261     History of Changes
Other Study ID Numbers: BUA 007-2011
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: April 2015

Keywords provided by Lekha S. Hota, Boston Urogynecology Associates:
Mechanical Bowel Prep

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