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)

Boston Urogynecology Associates

Status and phase: Unknown; Phase 1

Conditions: Pelvic Organ Prolapse

Treatments: Other: Mechanical Bowel Prep; Other: No Mechanical Bowel Prep

Study type: Interventional

Funder types: Other

Identifiers

NCT01522261

BUA 007-2011

Details and patient eligibility

About

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

Full 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.

Enrollment: 176 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

176 participants in 2 patient groups

Mechanical Bowel Prep

Active Comparator group

Description:

Patients randomized to complete a Mechanical Bowel Prep. (complete bowel cleansing) and fleet enemas prior to surgery.

Treatment:

Other: Mechanical Bowel Prep

No Mechanical Bowel Prep.

Active Comparator group

Description:

Patients randomized to complete two fleets enemas only prior to surgery.

Treatment:

Other: No Mechanical Bowel Prep