Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse; Prolapse
• Intervention / Treatment: Other: Bowel preparation; Other: No bowel preparation

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAC-SYM	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgeon perception of bowel preparation	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.	1 year
Return of normal bowel function	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.	1 year
Perioperative complications	Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions.	1 year

Collaborators and Investigators

• Sponsor: Halina M Zyczynski, MD
• Investigators: Principal Investigator: Kelly L Kantartzis, MD, University of Pittsburgh; Principal Investigator: Halina M Zyczynski, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: March 1, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (ESTIMATE): March 6, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pelvic organ prolapse; Prolapse; Cathartics; Mechanical bowel preparation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Gastrointestinal Agents; Cathartics; Magnesium citrate
• Other Study ID Numbers: PRO12020453