NCT01522261

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)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Boston Urogynecology Associates · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2012-01-31
• Last updated: 2015-04-20

Locations

1 site across 1 country: United States