Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 9, 2012
June 14, 2013
January 2012
January 2014   (final data collection date for 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. ] [ 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.
Same as current
Complete list of historical versions of study NCT01522261 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.
The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Pelvic Organ Prolapse
  • Other: Mechanical Bowel Prep
    Patients randomized to MBP will complete procedure per standard instructions.
  • Other: No Mechanical Bowel Prep
    Patient randomized to fleets enemas only prior to surgery
  • Active Comparator: Mechanical Bowel Prep
    Patients randomized to complete a Mechanical Bowel Prep. (complete bowel cleansing) and fleet enemas prior to surgery.
    Intervention: Other: Mechanical Bowel Prep
  • Active Comparator: No Mechanical Bowel Prep.
    Patients randomized to complete two fleets enemas only prior to surgery.
    Intervention: Other: No Mechanical Bowel Prep
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
176
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 90 Years
No
United States
 
NCT01522261
BUA 007-2011
No
Lekha S. Hota, Boston Urogynecology Associates
Boston Urogynecology Associates
Not Provided
Principal Investigator: Lekha Hota, M.D. Boston Urogynecology Associates
Boston Urogynecology Associates
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP