Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy

NCT01805310 | Completed Phase 4

• 1 other identifier: PRO12020453
• Study Type: interventional
• Actual enrollment (reported): 95
• Locations: 1 country
• Sites: 1
• Date type not reported: Study Start
• Actual (reported): Primary Completion
• Actual (reported): Study Completion

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.

Conditions

Pelvic Organ Prolapse; Prolapse

Keywords

Pelvic organ prolapse; Prolapse; Cathartics; Mechanical bowel preparation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Surgeon perception of bowel preparation

  1 year

• Return of normal bowel function

  1 year

• Perioperative complications

  1 year

Study Arms (2)

Bowel Preparation

OTHER

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

No bowel preparation

OTHER

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

Other: No bowel preparation

Interventions

Bowel preparation 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.

Also known as: Magnesium citrate

Bowel Preparation

No bowel preparation OTHER

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

No bowel preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Halina M Zyczynski, MD: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Interventions

Cathartics; magnesium citrate

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Kelly L Kantartzis, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Halina M Zyczynski, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Enrollment

95 participants — actual enrollment reported by the registry.

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 6, 2013
• Last Updated: January 9, 2018

Study Start

February 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2017

Actual (reported)

Study Completion

August 2017

Actual (reported)

Record last verified: 2018-01

Locations

US (1)