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)
Recruitment status was: Recruiting
|Pelvic Organ Prolapse||Other: Mechanical Bowel Prep Other: No Mechanical Bowel Prep||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Care Provider)
|Official Title:||The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)|
- 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.
- 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. ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522261
|United States, Massachusetts|
|Boston Urogynecology Associates||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Kathleen J Rogers 617-354-5452 email@example.com|
|Contact: Lekha Hota, M.D. 617-354-5452 firstname.lastname@example.org|
|Principal Investigator: Lekha Hota, M.D.|
|Principal Investigator:||Lekha Hota, M.D.||Boston Urogynecology Associates|