Acute Small Intestine ObstructionNCT03826251
Small Bowel Obstruction and Surgery
An observational study of Acute Small Intestine Obstruction, run by University Hospital, Angers.
Trial summary
Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Small Intestine Obstruction
- What is being tested?
- Nasogastric tube removal
- Type of treatment
- Surgery or procedure
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jun 2018
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers between January 1, 2014 and December 31, 2017
Who may be able to join
- Surgical management of Small bowel obstruction due to adhesions
Who cannot join
- obstruction not caused by single band adhesion
- matted adhesions, or if they were less than 18 years old
About this study
Official title: Nasogastric Tube After Small Bowel Obstruction Surgery is Not Mandatory: a Retrospective Cohort Study
Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs).
In elective surgery, ERPs have shown a significant benefit for the patient but this is not performed routinely in emergency surgery due to the difficulty to avoid postoperative nasogastric tube.
The aim was to identify risk factors for postoperative morbidity and for nasogastric tube (NGT) replacement after SBO surgery.
- Conditions
- Acute Small Intestine Obstruction
- Being tested
- Nasogastric tube removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric tube removalProcedure or surgery
Nasogastric tube was removed immediately after surgery
| Study group | Role | What they receive |
|---|---|---|
| systematic nasogastric tube | NGT was left systematically after surgery and removed after the first flattus | |
| Non systematic nasogastric tube | Nasogastric tube was removed immediately after surgery and was replaced in case of vomiting Receives: Procedure: Nasogastric tube removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morbidity
morbidity classified according to Dindo Clavien classification
Measured: within 30 days
Secondary outcomes (1)
Nasogastric tube replacement
nasogastric tube replacement after removal
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Small Intestine 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826251
- Sponsor's protocol ID
- UH Angers 2018/75
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasogastric Tube After Small Bowel Obstruction Surgery is Not Mandatory: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03826251
- Acronym / sponsor ID
- UH Angers 2018/75
- Conditions
- Acute Small Intestine Obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 1 Feb 2019 (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.
Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs).
In elective surgery, ERPs have shown a significant benefit for the patient but this is not performed routinely in emergency surgery due to the difficulty to avoid postoperative nasogastric tube.
The aim was to identify risk factors for postoperative morbidity and for nasogastric tube (NGT) replacement after SBO surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systematic nasogastric tube | – | –NGT was left systematically after surgery and removed after the first flattus |
| Non systematic nasogastric tube | – | Procedure: Nasogastric tube removalNasogastric tube was removed immediately after surgery and was replaced in case of vomiting |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers between January 1, 2014 and December 31, 2017
Key inclusion criteria (1 listed)
- Surgical management of Small bowel obstruction due to adhesions
Key exclusion criteria (2 listed)
- obstruction not caused by single band adhesion
- matted adhesions, or if they were less than 18 years old
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 |
|---|---|---|
| Nasogastric tube removalNasogastric tube was removed immediately after surgery | Procedure or surgery | Non systematic nasogastric tube |
Primary outcome
postoperative morbidity
Time frame: within 30 days
morbidity classified according to Dindo Clavien classification
1 secondary outcome
Nasogastric tube replacement
Time frame: within 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 1 Feb 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Small Intestine Obstruction, run by University Hospital, Angers.
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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
postoperative morbidity (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019; AzTrials last refreshed its copy on 27 Oct 2026.