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.

Pelvic Organ Prolapse Clinical Trial

— MBP  

Official title:

The Use of Mechanical Bowel Preparation in Pelvic Reconstructive Surgery (MBP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01522261
• Other study ID #: BUA 007-2011
• Status: Recruiting
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: April 17, 2015
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: April 2015
• Source: Boston Urogynecology Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse

Intervention

Other:
• Mechanical Bowel Prep
Patients randomized to MBP will complete procedure per standard instructions.
• No Mechanical Bowel Prep
Patient randomized to fleets enemas only prior to surgery

Locations

Country	Name	City	State
United States	Boston Urogynecology Associates	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Urogynecology Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Surgeons will be asked to complete a questionnaire re: their impressions of the visual field on immediately Post op.	No
Secondary	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.		We will be following the subject from the day of surgery through 2 weeks post op.	No