Enhanced Recovery Programs and Small Bowel Obstruction

Surgery Clinical Trial

— RACO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929275
• Other study ID #: 2021-A01015-36
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: December 3, 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 3, 2022
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adhesionnal small bowel obstruction requiring surgical management

Exclusion Criteria:

• No surgery

• Patients disagreeing to participate

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction
• Surgery

Intervention

Procedure:
• Enhanced recovery program
12 items of program (preoperative, peroperative postoperative) according to the enhanced recovery after surgery society

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurence rate of postoperative ileus		within 30 postoperative days
Secondary	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	within 30 postoperative days
Secondary	Postoperative morbidity		within 30 postoperative days
Secondary	length of stay		the day of discharge assessed up to 30 days
Secondary	Rate of nasogastric tube replacement		within 30 postoperative days
Secondary	Rate of tolerance to solid food		within 30 postoperative days
Secondary	Time to GI function recovery		within 30 postoperative days
Secondary	acceptability toward the enhanced recovery program	The acceptability will be assessed through 2 qualitative questions and a 1-10 satisfaction scale	the day of discharge up to 30 days