Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-08-31

Brief Summary

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Prior to surgery, gynecologists and urogynecologists have routinely prescribed preoperative mechanical bowel preparations in attempts to decrease the risk of infection, while also providing easier bowel manipulation and better visualization during surgery. However, many of these proposed benefits have never been proven, and usage of bowel preparations amongst surgeons remains highly variable. In both the general surgery and gynecology literature, researchers have begun to question the need for the vigorous preparations.

Aside from surgical visualization, urogynecologists have additional concerns about how bowel preparations may impact postoperative bowel function given up to half of women with pelvic floor disorders have baseline constipation and straining is known to impact surgical recovery. Many studies have addressed various postoperative fiber and laxative preparations in attempts to improve postoperative bowel-related symptomatology, but none have specifically looked at preoperative bowel preparations.

This study aims to determine if mechanical bowel preparation prior to minimally invasive sacral colpopexy affects patients' postoperative recovery, specifically related to bowel symptomatology; operative or post-operative complications; surgeons' perceptions of surgical difficulty directly attributed to the bowel; and post-operative return of normal bowel function.

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Detailed Description

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Conditions

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Pelvic Organ Prolapse Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Bowel Preparation

Women randomized to the bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one. They will also be placed on a clear liquid diet on preoperative day number one.

Group Type OTHER

Bowel preparation

Intervention Type OTHER

Subjects randomized to the mechanical bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one.

No bowel preparation

Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Group Type OTHER

No bowel preparation

Intervention Type OTHER

Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Interventions

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Bowel preparation

Subjects randomized to the mechanical bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one.

Intervention Type OTHER

No bowel preparation

Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Intervention Type OTHER

Other Intervention Names

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Magnesium citrate

Eligibility Criteria

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Inclusion Criteria

* Female
* Age ≥ 18 years
* Planned laparoscopic or robotic-assisted sacral colpopexy

Exclusion Criteria

* History of ulcerative colitis or Crohn's disease
* Prior large or small bowel resection
* Known diagnosis of gastroparesis
* Prior pelvic radiation
* History of abdominal or pelvic malignancy
* Planned concurrent bowel surgery/anal sphincteroplasty/ rectovaginal fistula repair
* Pregnancy
* Known allergic reactions to components of the study products
* Known renal insufficiency
* Non-English speaking as the primary study questionnaires are all currently in English only

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No