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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-01-31

Brief Summary

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

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Detailed Description

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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

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Mechanical Bowel Prep

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

Group Type ACTIVE_COMPARATOR

Mechanical Bowel Prep

Intervention Type OTHER

Patients randomized to MBP will complete procedure per standard instructions.

No Mechanical Bowel Prep.

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

Group Type ACTIVE_COMPARATOR

No Mechanical Bowel Prep

Intervention Type OTHER

Patient randomized to fleets enemas only prior to surgery

Interventions

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Mechanical Bowel Prep

Patients randomized to MBP will complete procedure per standard instructions.

Intervention Type OTHER

No Mechanical Bowel Prep

Patient randomized to fleets enemas only prior to surgery

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No