Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Primary Purpose
Pelvic Organ Prolapse, Prolapse
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bowel preparation
No bowel preparation
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Prolapse, Cathartics, Mechanical bowel preparation
Eligibility Criteria
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
Sites / Locations
- University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Bowel Preparation
No bowel preparation
Arm Description
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.
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01805310
Brief Title
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Official Title
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Halina M Zyczynski, MD
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Prolapse
Keywords
Pelvic organ prolapse, Prolapse, Cathartics, Mechanical bowel preparation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bowel Preparation
Arm Type
Other
Arm Description
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.
Arm Title
No bowel preparation
Arm Type
Other
Arm Description
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
Intervention Type
Other
Intervention Name(s)
Bowel preparation
Other Intervention Name(s)
Magnesium citrate
Intervention Description
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
Intervention Name(s)
No bowel preparation
Intervention Description
Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
Primary Outcome Measure Information:
Title
PAC-SYM
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Surgeon perception of bowel preparation
Description
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.
Time Frame
1 year
Title
Return of normal bowel function
Description
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.
Time Frame
1 year
Title
Perioperative complications
Description
Complications occurring in both groups will be recorded. These include, but are not limited to infections, bowel obstructions, visceral organ injuries, and readmissions.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly L Kantartzis, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halina M Zyczynski, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pre-operative Bowel Preparation Prior to Minimally Invasive Sacral Colpopexy
We'll reach out to this number within 24 hrs