Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Sponsor

Halina M Zyczynski, MD (Other)

Overall Status

Completed

CT.gov ID

NCT01805310

Collaborator

(none)

Enrollment

Location

Arms

53.9

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Prolapse	Other: Bowel preparation Other: No bowel preparation	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Other: 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. Other Names: Magnesium citrate
Other: No bowel preparation Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.	Other: No bowel preparation Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.

Arm

Intervention/Treatment

Other: 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.

Other: 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.

Other Names:

Magnesium citrate

Other: No bowel preparation

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

Other: No bowel preparation

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

Outcome Measures

Primary Outcome Measures

PAC-SYM [1 year]
Bowel symptomatology and bowel-related discomfort will be assessed with the Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM), a 12-item questionnaire covering three domains: abdominal, rectal, and stool.

Secondary Outcome Measures

Surgeon perception of bowel preparation [1 year]
Immediately after completing the surgical case, surgeons will complete a 13-item surgeon questionnaire assessing degree of surgical difficulty and how it relates to the bowel. Operative time and consultations will also be recorded as objective measures of surgical difficulty.
Return of normal bowel function [1 year]
A seven-day bowel diary will be obtained at baseline and in the first week after surgery. This log will include daily assessment of bowel frequency, type of bowel movement using the validated Bristol stool scale, degree of straining, and used of narcotics or laxatives.
Perioperative complications [1 year]
Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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