Small Bowel Obstruction AdhesionBOWNTINCT06347120
Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction
A study testing nasogastric tube and NOM without NGT insertion in people with Small Bowel Obstruction Adhesion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Small Bowel Obstruction Adhesion
- What is being tested?
- nasogastric tube and NOM without NGT insertion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of an obstruction believed to be secondary to adhesions (abdominal pain and distention, nausea and/or vomiting, no gas and/or stool).
- Uncomplicated presentation (no signs of strangulation or peritonitis).
- IV CT scan of the abdomen consistent with an uncomplicated ASBO, (performed with a pillow to raise slightly the patient.
- Aged 18 or older.
- Provision of written, informed consent.
- Patient covered by French national health insurance.
Who cannot join
- An incarcerated and/or strangulated incisional hernia, colonic obstruction.
- No previous abdominal operation.
- Obstruction within 4 weeks after a recent operation.
- Gastrointestinal neoplasm in progress.
- Inflammatory bowel disease in progress.
- Abdominal radiotherapy in the last 6 months.
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- Contraindication to intravenous contrast enhancement for the CT scan, pre-existing risks factors for pneumonitis.
- Antecedent of aspiration pneumonia.
- Age > 85 years.
- Orientation disturbance.
- Bedridden.
- Chronic cerebrovascular disease (cerebral infarction sequelae, Parkinson disease etc).
- Dementia.
- Gastroesophageal disorder (gastroesophageal reflux)
- Pregnancy or breastfeeding.
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
- Patients unable to provide informed consent.
- Age <18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens Universitary Hospital
Amiens
jean marc Regimbeau, Pr, +33 3 22 08 89 05, regimbeau.jean-marc@chu-amiens.fr
charles sabbagh, Pr
About this study
Official title: Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction : a Randomized Open-label Non-inferiority Trial
Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.
The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) :
Read more
- OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours;
- NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.
NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM.
However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia.
Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.
To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO.
- Conditions
- Small Bowel Obstruction Adhesion
- Being tested
- nasogastric tube, NOM without NGT insertion
- Keywords
- Small Bowel Obstruction Adhesion, nasogastric tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasogastric tubeProcedure or surgery
nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.
NOM without NGT insertionOther
intravenous administration of fluids, nill per os, analgesic, antiemetic treatment, and clinical and biochemical monitoring for 72h
| Study group | Role | What they receive |
|---|---|---|
| Control group (NGT+ group) | Active comparator | Patients treated with standard NOM (NGT, intravenous administration of fluids, nill per os, analgesic, antiemetic treatment, and clinical and biochemical monitoring for 72h) Receives: Procedure: nasogastric tube |
| Experimental group (NGT- group) | Experimental | Patients treated with NOM without NGT insertion (intravenous administration of fluids, nill per os, analgesic, antiemetic treatment, and clinical and biochemical monitoring for 72h) Receives: Other: NOM without NGT insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of complication rate in patient without NGT group compared to control group
Decrease of complication rate in patient without NGT group compared to control group
Measured: 3 years
Secondary outcomes (1)
aspiration pneumonia rate in both patient groups
aspiration pneumonia rate in both patient groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Apr 2024
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel Obstruction AdhesionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais, CHU de Rouen - Accueil, Hospital Avicenne, Centre Hospitalier Universitaire Dijon, University Hospital, Limoges, Saint Antoine University Hospital, Centre Hospitalier Universitaire de Besancon, Hôpital Cochin, University Hospital, Toulouse, Abbeville Hospital Center, University Hospital, Angers
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347120
- Sponsor's protocol ID
- PI2024_843_0011
- Acronym
- BOWNTI
- Status last verified
- May 2024
- First submitted
- 19 Mar 2024
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction : a Randomized Open-label Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06347120
- Acronym / sponsor ID
- BOWNTI / PI2024_843_0011
- Conditions
- Small Bowel Obstruction Adhesion
- Keywords
- Small Bowel Obstruction Adhesion, nasogastric tube
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais, CHU de Rouen - Accueil, Hospital Avicenne, Centre Hospitalier Universitaire Dijon, University Hospital, Limoges, Saint Antoine University Hospital, Centre Hospitalier Universitaire de Besancon, Hôpital Cochin, University Hospital, Toulouse, Abbeville Hospital Center, University Hospital, Angers
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Apr 2024 (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.
Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.
The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) :
- OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours;
- NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.
NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM.
However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia.
Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.
To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (NGT+ group) | Active comparator | Procedure: nasogastric tubePatients treated with standard NOM (NGT, intravenous administration of fluids, nill per os, analgesic, antiemetic treatment, and clinical and biochemical monitoring for 72h) |
| Experimental group (NGT- group) | Experimental | Other: NOM without NGT insertionPatients treated with NOM without NGT insertion (intravenous administration of fluids, nill per os, analgesic, antiemetic treatment, and clinical and biochemical monitoring for 72h) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of an obstruction believed to be secondary to adhesions (abdominal pain and distention, nausea and/or vomiting, no gas and/or stool).
- Uncomplicated presentation (no signs of strangulation or peritonitis).
- IV CT scan of the abdomen consistent with an uncomplicated ASBO, (performed with a pillow to raise slightly the patient.
- Aged 18 or older.
- Provision of written, informed consent.
Key exclusion criteria (18 listed)
- An incarcerated and/or strangulated incisional hernia, colonic obstruction.
- No previous abdominal operation.
- Obstruction within 4 weeks after a recent operation.
- Gastrointestinal neoplasm in progress.
- Inflammatory bowel disease in progress.
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 tubenasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h. | Procedure or surgery | Control group (NGT+ group) |
| NOM without NGT insertionintravenous administration of fluids, nill per os, analgesic, antiemetic treatment, and clinical and biochemical monitoring for 72h | Other | Experimental group (NGT- group) |
Primary outcome
Decrease of complication rate in patient without NGT group compared to control group
Time frame: 3 years
Decrease of complication rate in patient without NGT group compared to control group
1 secondary outcome
aspiration pneumonia rate in both patient groups
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasogastric tube and NOM without NGT insertion in people with Small Bowel Obstruction Adhesion, run by Centre Hospitalier Universitaire, Amiens 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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 16 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Marc Regimbeau, Pr (322 088 897, regimbeau.jean-marc@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of complication rate in patient without NGT group compared to control group (time frame: 3 years). 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 16 May 2024.