Back to resultsEnhanced Recovery Programs and Small Bowel Obstruction (RACO)
Primary Purpose
Small Bowel Obstruction, Surgery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Enhanced recovery program
Sponsored by
About this trial
This is an interventional treatment trial for Small Bowel Obstruction
Eligibility Criteria
Inclusion Criteria:
- Adhesionnal small bowel obstruction requiring surgical management
Exclusion Criteria:
- No surgery
- Patients disagreeing to participate
Sites / Locations
- UH Angers
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Enhanced recovery program
Arm Description
Outcomes
Primary Outcome Measures
occurence rate of postoperative ileus
Secondary Outcome Measures
Feasibility of the enhanced recovery program after small bowel obstruction surgery
The feasibility of the enhanced recovery program will be assessed by using the ratio: number of items of the programs followed/ number of items in the programs
Postoperative morbidity
length of stay
Rate of nasogastric tube replacement
Rate of tolerance to solid food
Time to GI function recovery
acceptability toward the enhanced recovery program
The acceptability will be assessed through 2 qualitative questions and a 1-10 satisfaction scale
Full Information
NCT ID
NCT04929275
First Posted
May 29, 2021
Last Updated
September 21, 2023
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT04929275
Brief Title
Enhanced Recovery Programs and Small Bowel Obstruction
Acronym
RACO
Official Title
Feasability and Impact of Enhanced Recovery Programs After Surgery for Small Bowel Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
November 3, 2022 (Actual)
Study Completion Date
December 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Small bowel obstruction surgery is frequent and would benefit from enhanced recovery programs. While some studies advocate for their feasibility, it has never been proved and prospective studies are required to confirm the feasibility of such program and the impact on postoperative outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced recovery program
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Enhanced recovery program
Intervention Description
12 items of program (preoperative, peroperative postoperative) according to the enhanced recovery after surgery society
Primary Outcome Measure Information:
Title
occurence rate of postoperative ileus
Time Frame
within 30 postoperative days
Secondary Outcome Measure Information:
Title
Feasibility of the enhanced recovery program after small bowel obstruction surgery
Description
The feasibility of the enhanced recovery program will be assessed by using the ratio: number of items of the programs followed/ number of items in the programs
Time Frame
within 30 postoperative days
Title
Postoperative morbidity
Time Frame
within 30 postoperative days
Title
length of stay
Time Frame
the day of discharge assessed up to 30 days
Title
Rate of nasogastric tube replacement
Time Frame
within 30 postoperative days
Title
Rate of tolerance to solid food
Time Frame
within 30 postoperative days
Title
Time to GI function recovery
Time Frame
within 30 postoperative days
Title
acceptability toward the enhanced recovery program
Description
The acceptability will be assessed through 2 qualitative questions and a 1-10 satisfaction scale
Time Frame
the day of discharge up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adhesionnal small bowel obstruction requiring surgical management
Exclusion Criteria:
No surgery
Patients disagreeing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélien Venara, MD PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Angers
City
Angers
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Enhanced Recovery Programs and Small Bowel Obstruction
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