Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy
Primary Purpose
Constipation, Post-Op Complication
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Polyethylene Glycol Powder
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures
Exclusion Criteria:
- Age under 18 or over 90
- Planned laparotomy
- Planned posterior colporrhaphy
- Regular pre-operative use of stool softeners/laxatives
- Presence of colostomy
- Inability to give informed consent
- Inability to take medication by mouth
- Chronic kidney disease (Cr > 1.2)
- Esophageal strictures
- Persistent nausea and vomiting
- Bowel obstruction
- Inflammatory bowel disease
Sites / Locations
- South Shore University Hospital Northwell Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
The control group will not be given any intervention preoperatively.
Outcomes
Primary Outcome Measures
First bowel movement
Time to first post-operative bowel movement will be evaluated.
Secondary Outcome Measures
Post operative pain as measured by the VAS scale.
Patients will record their daily pain levels using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.
Post operative pain with first bowel movement as measured by the VAS scale
Patients will record their pain level with their first post-operative bowel movement using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.
Stool consistency of first bowel movement as measure by the Bristol Stool Scale
Patients will record the stool consistency with their first bowel movement post-operatively using the Bristol Stool Scale. The scale is composed of stool types 1-7 with 1 being hard and lumpy stool and 7 being completely liquid.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04197869
Brief Title
Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy
Official Title
Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
June 21, 2023 (Actual)
Study Completion Date
June 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
Detailed Description
In order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. The patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. Patients will record if they are taking their Miralax as prescribed daily. They will also record their bowel movements and pain levels during evacuation. Prior to surgery, in the pre-operative area, medication compliance will be assessed once again. Post operatively all patients will take polyethylene glycol for seven days, once a day. They will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. The primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Post-Op Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will not be given any intervention preoperatively.
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol Powder
Intervention Description
Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration. Polyethylene glycol is a high molecular weight, water soluble polymer which can form hydrogen bonds with water molecules. It is an osmotic laxative solution which stimulates bowel movements by increasing the amount of water absorbed in the GI tract. It decreases feces consistency and increases their volume by promoting peristalsis and evacuation. The side effects of polyethylene glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 hours and after 18 hours the concentration declines to non-quantifiable levels.
Primary Outcome Measure Information:
Title
First bowel movement
Description
Time to first post-operative bowel movement will be evaluated.
Time Frame
7 days post-operatively
Secondary Outcome Measure Information:
Title
Post operative pain as measured by the VAS scale.
Description
Patients will record their daily pain levels using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.
Time Frame
7 days post-operatively
Title
Post operative pain with first bowel movement as measured by the VAS scale
Description
Patients will record their pain level with their first post-operative bowel movement using the Visual Analogue Scale (VAS) pain scale. The scale is numbered 0 through 10, with 0 being no pain and 10 being worst possible pain.
Time Frame
7 days post-operatively
Title
Stool consistency of first bowel movement as measure by the Bristol Stool Scale
Description
Patients will record the stool consistency with their first bowel movement post-operatively using the Bristol Stool Scale. The scale is composed of stool types 1-7 with 1 being hard and lumpy stool and 7 being completely liquid.
Time Frame
7 days post-operatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing a robotic assisted sacrocolpopexy with or without hysterectomy and with or without anti-incontinence procedures
Exclusion Criteria:
Age under 18 or over 90
Planned laparotomy
Planned posterior colporrhaphy
Regular pre-operative use of stool softeners/laxatives
Presence of colostomy
Inability to give informed consent
Inability to take medication by mouth
Chronic kidney disease (Cr > 1.2)
Esophageal strictures
Persistent nausea and vomiting
Bowel obstruction
Inflammatory bowel disease
Facility Information:
Facility Name
South Shore University Hospital Northwell Health
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy
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