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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01522261

Acronym

MBP

Enrollment

176

Registered

2012-01-31

Start date

2012-01-31

Completion date

2017-01-31

Last updated

2015-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

Mechanical Bowel Prep

Brief 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.

Interventions

OTHERMechanical Bowel Prep

Patients randomized to MBP will complete procedure per standard instructions.

OTHERNo Mechanical Bowel Prep

Patient randomized to fleets enemas only prior to surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.	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.

Secondary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026