Small Bowel ObstructionRACONCT04929275
Enhanced Recovery Programs and Small Bowel Obstruction
A study testing Enhanced recovery program in people with Small Bowel Obstruction and Surgery, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction, Surgery
- What is being tested?
- Enhanced recovery program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2021to 3 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adhesionnal small bowel obstruction requiring surgical management
Who cannot join
- No surgery
- Patients disagreeing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Small Bowel Obstruction, Surgery
- Being tested
- Enhanced recovery program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery programProcedure or surgery
12 items of program (preoperative, peroperative postoperative) according to the enhanced recovery after surgery society
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery program | Other | Not described Receives: Procedure: Enhanced recovery program |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence rate of postoperative ileus
Measured: within 30 postoperative days
Secondary outcomes (7)
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
Measured: within 30 postoperative days
Postoperative morbidity
Measured: within 30 postoperative days
length of stay
Measured: the day of discharge assessed up to 30 days
Rate of nasogastric tube replacement
Measured: within 30 postoperative days
Rate of tolerance to solid food
Measured: within 30 postoperative days
Time to GI function recovery
Measured: within 30 postoperative days
acceptability toward the enhanced recovery program
The acceptability will be assessed through 2 qualitative questions and a 1-10 satisfaction scale
Measured: the day of discharge up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start25 Jun 2021
- Primary completion3 Nov 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aurélien Venara, MD PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929275
- Sponsor's protocol ID
- 2021-A01015-36
- Acronym
- RACO
- Status last verified
- May 2021
- First submitted
- 29 May 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38900305
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasability and Impact of Enhanced Recovery Programs After Surgery for Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT04929275
- Acronym / sponsor ID
- RACO / 2021-A01015-36
- Conditions
- Small Bowel Obstruction, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery program | Other | Procedure: Enhanced recovery program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adhesionnal small bowel obstruction requiring surgical management
Key exclusion criteria (2 listed)
- No surgery
- Patients disagreeing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery program12 items of program (preoperative, peroperative postoperative) according to the enhanced recovery after surgery society | Procedure or surgery | Enhanced recovery program |
Primary outcome
occurence rate of postoperative ileus
Time frame: within 30 postoperative days
7 secondary outcomes
Feasibility of the enhanced recovery program after small bowel obstruction surgery
Time frame: within 30 postoperative days
Postoperative morbidity
Time frame: within 30 postoperative days
length of stay
Time frame: the day of discharge assessed up to 30 days
Rate of nasogastric tube replacement
Time frame: within 30 postoperative days
Rate of tolerance to solid food
Time frame: within 30 postoperative days
Time to GI function recovery
Time frame: within 30 postoperative days
acceptability toward the enhanced recovery program
Time frame: the day of discharge up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 38900305M 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien Venara, MD PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery program in people with Small Bowel Obstruction and Surgery, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence rate of postoperative ileus (time frame: within 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.