Enhanced Recovery Programs and Small Bowel Obstruction (RACO)

September 21, 2023 updated by: University Hospital, Angers

Feasability and Impact of Enhanced Recovery Programs After Surgery for Small Bowel Obstruction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Uh Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adhesionnal small bowel obstruction requiring surgical management

Exclusion Criteria:

  • No surgery
  • Patients disagreeing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enhanced recovery program
Procedure: Enhanced recovery program
12 items of program (preoperative, peroperative postoperative) according to the enhanced recovery after surgery society

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
occurence rate of postoperative ileus
Time Frame: within 30 postoperative days
within 30 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of the enhanced recovery program after small bowel obstruction surgery
Time Frame: within 30 postoperative days
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
within 30 postoperative days
Postoperative morbidity
Time Frame: within 30 postoperative days
within 30 postoperative days
length of stay
Time Frame: the day of discharge assessed up to 30 days
the day of discharge assessed up to 30 days
Rate of nasogastric tube replacement
Time Frame: within 30 postoperative days
within 30 postoperative days
Rate of tolerance to solid food
Time Frame: within 30 postoperative days
within 30 postoperative days
Time to GI function recovery
Time Frame: within 30 postoperative days
within 30 postoperative days
acceptability toward the enhanced recovery program
Time Frame: the day of discharge up to 30 days
The acceptability will be assessed through 2 qualitative questions and a 1-10 satisfaction scale
the day of discharge up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Aurélien Venara, MD PhD, Uh Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2021

Primary Completion (Actual)

November 3, 2022

Study Completion (Actual)

December 3, 2022

Study Registration Dates

First Submitted

May 29, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01015-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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