NCT04929275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

June 25, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

September 22, 2023

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

May 29, 2021

Last Update Submit

September 21, 2023

Conditions

Small Bowel ObstructionSurgery

Outcome Measures

Primary Outcomes (1)

  • occurence rate of postoperative ileus

    within 30 postoperative days

Secondary Outcomes (7)

  • Feasibility of the enhanced recovery program after small bowel obstruction surgery

    within 30 postoperative days

  • Postoperative morbidity

    within 30 postoperative days

  • length of stay

    the day of discharge assessed up to 30 days

  • Rate of nasogastric tube replacement

    within 30 postoperative days

  • Rate of tolerance to solid food

    within 30 postoperative days

  • +2 more secondary outcomes

Study Arms (1)

Enhanced recovery program

OTHER
Procedure: Enhanced recovery program

Interventions

Enhanced recovery programPROCEDURE

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

Enhanced recovery program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adhesionnal small bowel obstruction requiring surgical management

You may not qualify if:

  • No surgery
  • Patients disagreeing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Angers

Angers, France

Location

Related Publications (1)

  • M L, G B, F F, M B, M D, E PS, Jf H, A V. Enhanced recovery programs following adhesive small bowel obstruction surgery are feasible and reduce the rate of postoperative ileus: a preliminary study. Langenbecks Arch Surg. 2024 Jun 20;409(1):191. doi: 10.1007/s00423-024-03389-7.

    PMID: 38900305DERIVED

Study Officials

  • Aurélien Venara, MD PhD

    UH Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2021

First Posted

June 18, 2021

Study Start

June 25, 2021

Primary Completion

November 3, 2022

Study Completion

December 3, 2022

Last Updated

September 22, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)