Small Bowel ObstructionSURGI-BOWNCT06065150
Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction (SURGI-BOW)
A study testing Standard support and Early surgery proposed according to the radiological score in people with Small Bowel Obstruction, run by University Hospital, Angers at 14 sites in France.
Trial summary
For uncomplicated acute small bowel obstruction (aSBO), the "Bologna guidelines" recommend non-surgical management of 72 hours before considering surgery. This treatment is based on the placement of a nasogastric tube and the correction of hydro-electrolyte disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- Standard support and Early surgery proposed according to the radiological score
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- 14 sitesFrance
- Study dates
- 30 Jan 2024to 29 Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission for acute intestinal obstruction of the small intestine on adhesion or bridle
- Confirmation of the aSBO by a scanner
- Adult patient
- Beneficiary of a social security scheme
- Having signed an informed consent
Who cannot join
- Indication for urgent surgery (small intestine ischemia, intestinal pain, defence, hemodynamic shock, etc.)
- Pregnancy or breastfeeding
- Poor understanding of the French language
- Person deprived of liberty by judicial or administrative decision
- Person undergoing psychiatric treatment under duress
- Person subject to a legal protection measure
- Person unable to express consent
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Not yet recruiting
University Hospital of Amiens
Amiens, 80054
Jean-Marc REGIMBEAU, Pr, 3 22 08 89 00 ext. 33, regimbeau.jean-marc@chu-amiens.fr
- Recruiting
University Hospital of Angers
Angers, 49933
Aurélien VENARA, Pr, 2 41 35 49 16 ext. 33, aurelien.venara@chu-angers.fr
- Not yet recruiting
University Hospital of Brest
Brest, 29609
Bogdan BADIC, Pr, 2 98 34 72 35 ext. 33, bogdan.badic@chu-brest.fr
- Recruiting
University Hospital of Tours
Chambray-lès-Tours, 37170
Mehdi OUAISSI, Pr, 2 18 37 05 75 ext. 33, m.ouaissi@chu-tours.fr
- Not yet recruiting
Hospital of Haut Anjou
Château-Gontier, 53200
Marine SARFATI-LEBRETON, DR, 2 43 09 33 55 ext. 33, Marine.SarfatiLebreton@chu-angers.fr
- Not yet recruiting
University Hospital of Dijon Bourgogne
Dijon, 21000
Pablo ORTEGA DEBALLON, Pr, 3 80 29 37 47 ext. 33, pablo.ortega-deballon@chu-dijon.fr
- Recruiting
University Hospital of Grenoble-Alpes
Grenoble, 38043
Edouard GIRARD, Dr, 4 76 76 54 65 ext. 33, egirard1@chu-grenoble.fr
- Recruiting
Hospital of Vendée
La Roche-sur-Yon, 85925
Emeric ABET, Dr, 2 51 44 61 61 ext. 33, emeric.abet@ght85.fr
- Not yet recruiting
University Hospital of Montpellier
Montpellier, 34295
François-Régis SOUCHE, Pr, 4 67 33 70 72 ext. 33, fr-souche@chu-montpellier.fr
- Not yet recruiting
University Hospital of Nantes
Nantes, 44093
Emilie DUCHALAIS, Dr, 2 40 08 33 33 ext. 33, emilie.duchalais@chu-nantes.fr
- Not yet recruiting
University Hospital of Nice
Nice, 06000
Damien MASSALOU, Dr, 4 92 03 77 77 ext. 33, massalou.d@chu-nice.fr
- Not yet recruiting
University Hospital of Lyon
Pierre-Bénite, 69495
Guillaume PASSOT, Pr, 4 78 86 23 71 ext. 33, guillaume.passot@chu-lyon.fr
- Not yet recruiting
University Hospital of Rennes
Rennes, 35033
Fabien ROBIN, Dr, 2 99 28 90 37 ext. 33, Fabien.ROBIN@chu-rennes.fr
- Not yet recruiting
University Hospital of Strasbourg
Strasbourg, 67098
Cécile BRIGAND, Pr, 3 88 12 72 26, cecile.brigand@chru-strasbourg.fr
About this study
Official title: SURGI-BOW - Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: a Randomized Open-label Controlled Study
For uncomplicated acute small bowel obstruction (aSBO), the "Bologna guidelines" recommend non-surgical management of 72 hours before considering surgery. This treatment is based on the placement of a nasogastric tube and the correction of hydro-electrolyte disorders. Non-surgical management is only effective in 60 to 70% and surgery is therefore necessary in 30 to 40% of cases after medical treatment for at least 3 days. This therefore leads to an increase in the length of hospital stay. Some authors also point out that postponing surgery for 3 days would aggravate the morbidity and mortality of surgery. Indeed, aSBO surgery has a complication rate of 10-40% and a mortality of up to 4%.
There is a lack of studies evaluating what is the best management strategy for aSBO, especially with regard to the duration of medical treatment. Many recent studies plead in favor of early surgical treatment (<24 hours) which would reduce the morbidity and mortality rate of surgery but also the overall cost of treatment by reducing the length of stay.
Read more
This paradigm shift is linked to the improvement of anesthetic and intensive care management over the last few years, but also to the advent of laparoscopy in emergency surgery. Indeed, laparoscopy could reduce the duration of hospitalization but also the operative morbidity and mortality. However, this surgical approach is not feasible in all situations and the conversion rate is reported in 30 to 76% of cases. One of the factors favoring the feasibility of the laparoscopic approach is the performance of early surgery.
Another parameter favoring the feasibility of the laparoscopic approach is the aSBO mechanism: an aSBO on flange (SBA) is more likely to be treated effectively by laparoscopic than an aSBO on multiple adhesions (MA).
In the literature, there is little to differentiate SBAs from MAs. Advances in CT scans have made it possible to describe the signs associated with the SBA mechanism and then to propose a score making it possible to predict the SBA mechanism with good performance (sensitivity 67.6%, specificity 84.6%). This score not only has the advantage of predicting the mechanism of the occlusion but it also makes it possible to predict the failure of non-surgical treatment if the score is ≥5.
Read the detailed description
Multicentre randomized open-label controlled trial. Patients admitted to visceral surgery for aSBO are screened and the study is offered for patients who do not meet the criteria for emergency surgery.
If they accept the study, a randomization is carried out by stratification according to (i) the sex, (ii) the center (University hospital/ Peripheral center), (iii) the number of previous episodes of aSBO (0 or ≥1 ) and the value of the radiological score (< or ≥5).
Patients are cared for according to the strategy defined by randomisation (standard procedure vs early surgery proposed according to the radiological score). Demographic information, medical and surgical history, and treatments are collected on the day of admission.
A visit is made each day (from admission to discharge) to collect information on the surgery (if performed), on the medical management and its success or failure (if applicable), on the recovery of functions gastrointestinal, on perioperative management, on morbidity and mortality.
Patients have a follow-up consultation on D30 and D90 postoperative. Any morbidity, mortality or recurrence that occurred during this period is collected.
Patients are contacted by telephone after 12 months to ensure that no recurrence of aSBO has occurred.
- Conditions
- Small Bowel Obstruction
- Being tested
- Standard support, Early surgery proposed according to the radiological score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard supportProcedure or surgery
See arm/group descriptions
Early surgery proposed according to the radiological scoreProcedure or surgery
- If score ≥ 5: the risk of medical treatment failure is multiplied by 2.9 (Feuerstoss F et al, J Gastrointest Surg 2021). Early surgical treatment is proposed; that is, the procedure is performed within 24 hours of admission. The surgery is initiated by laparoscopy and converted to open surgery if necessary.
- If score < 5: the risk of medical treatment failure is reduced. Initial medical treatment is therefore offered in accordance with standard management.
| Study group | Role | What they receive |
|---|---|---|
| Standard support | Active comparator | Initial medical treatment: placement of a nasogastric tube associated with hydration and vascular filling for hypovolaemic patients. Other medical treatments for occlusive small bowel syndrome on adhesion or flange can be performed but are not systematically recommended. Their use is left to the discretion of the surgeon. Medical treatment is carried out over 72 hours from admission.
In case of resumption of a transit by gas and/or stools associated with a tolerance to the food, the exit is authorized without resorting to surgery. In the absence of a resumption of transit by gas and/or stools associated with tolerance to food, semi-urgent surgical management is proposed 72 hours from the start of management. In the event of deterioration of the clinical condition during hospitalization, urgent surgery will be proposed, according to the recommendations for use. Receives: Procedure: Standard support |
| Early surgery proposed according to the radiological score | Experimental | Patients included in the experimental arm have treatment adapted to the radiological score. The radiological score described by Berge et al. (Berge et al. Eur J Trauma Emerg Surg 2021) is calculated after patient inclusion. Receives: Procedure: Early surgery proposed according to the radiological score |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day morbidity and mortality of aSBO management using the radiological score
The main objective is to evaluate the effectiveness, in terms of 90-day morbidity and mortality, of management of uncomplicated aSBO based on the use of the radiological score as a tool to select patients eligible for early surgery. compared to standard care (medical treatment for 72 hours).
Measured: 90 days
Secondary outcomes (6)
Morbidity and mortality at 30 days
Morbidity and mortality at 30 days of aSBO management
Measured: 30 days
Length of patient hospitalization
Time between admission and discharge from hospitalization
Measured: assessed to 2 days
Recurrence rate of aSBO
Recurrence rate of aSBO after the episode. Recurrence is defined by any admission of the patient for nausea/vomiting and absence of flatulence and stools with a CT scan showing distension of the small intestine within one year of admission.
Measured: one year
Rate of recourse to surgery for patients not operated on straight away
Recourse to surgery is defined by a surgical intervention carried out for the treatment of aSBO
Measured: One year
Surgical morbidity and mortality at 30 days of patients operated on during the first hospitalization
Surgical morbidity and mortality at 30 days of aSBO management defined as the appearance of a deviation from the normal course of expected surgical outcomes between the day of hospitalization and the 30th day. Morbi-mortality is classified according to the Dindo-Clavien scale. Morbi-mortality is collected only for surgical patients, and if the episode is secondary to surgical treatment.
Measured: 30 days
Laparoscopic surgery rate
Laparoscopic surgery rate is defined as the number of surgeries performed from incision to closure by laparoscopic approach out of the total number of surgeries. The need for conversion by laparotomy will also be collected and compared between the 2 groups
Measured: Surgery time assessed to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start30 Jan 2024
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre randomized open-label controlled trial
- Masking
- None (open label)
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Cécile Jaglin-Grimonprez, Study director, University hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065150
- Sponsor's protocol ID
- 2023-A00875-40
- Acronym
- SURGI-BOW
- Status last verified
- Jun 2024
- First submitted
- 13 Sep 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURGI-BOW - Early Surgery Versus 3 Days Non-surgical Management in Acute Small Bowel Obstruction: a Randomized Open-label Controlled Study
- ClinicalTrials.gov ID
- NCT06065150
- Acronym / sponsor ID
- SURGI-BOW / 2023-A00875-40
- Conditions
- Small Bowel Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 3 Oct 2023 (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.
For uncomplicated acute small bowel obstruction (aSBO), the "Bologna guidelines" recommend non-surgical management of 72 hours before considering surgery. This treatment is based on the placement of a nasogastric tube and the correction of hydro-electrolyte disorders. Non-surgical management is only effective in 60 to 70% and surgery is therefore necessary in 30 to 40% of cases after medical treatment for at least 3 days. This therefore leads to an increase in the length of hospital stay. Some authors also point out that postponing surgery for 3 days would aggravate the morbidity and mortality of surgery. Indeed, aSBO surgery has a complication rate of 10-40% and a mortality of up to 4%.
There is a lack of studies evaluating what is the best management strategy for aSBO, especially with regard to the duration of medical treatment. Many recent studies plead in favor of early surgical treatment (<24 hours) which would reduce the morbidity and mortality rate of surgery but also the overall cost of treatment by reducing the length of stay.
This paradigm shift is linked to the improvement of anesthetic and intensive care management over the last few years, but also to the advent of laparoscopy in emergency surgery. Indeed, laparoscopy could reduce the duration of hospitalization but also the operative morbidity and mortality. However, this surgical approach is not feasible in all situations and the conversion rate is reported in 30 to 76% of cases. One of the factors favoring the feasibility of the laparoscopic approach is the performance of early surgery.
Another parameter favoring the feasibility of the laparoscopic approach is the aSBO mechanism: an aSBO on flange (SBA) is more likely to be treated effectively by laparoscopic than an aSBO on multiple adhesions (MA).
In the literature, there is little to differentiate SBAs from MAs. Advances in CT scans have made it possible to describe the signs associated with the SBA mechanism and then to propose a score making it possible to predict the SBA mechanism with good performance (sensitivity 67.6%, specificity 84.6%). This score not only has the advantage of predicting the mechanism of the occlusion but it also makes it possible to predict the failure of non-surgical treatment if the score is ≥5.
Detailed description
Multicentre randomized open-label controlled trial. Patients admitted to visceral surgery for aSBO are screened and the study is offered for patients who do not meet the criteria for emergency surgery.
If they accept the study, a randomization is carried out by stratification according to (i) the sex, (ii) the center (University hospital/ Peripheral center), (iii) the number of previous episodes of aSBO (0 or ≥1 ) and the value of the radiological score (< or ≥5).
Patients are cared for according to the strategy defined by randomisation (standard procedure vs early surgery proposed according to the radiological score). Demographic information, medical and surgical history, and treatments are collected on the day of admission.
A visit is made each day (from admission to discharge) to collect information on the surgery (if performed), on the medical management and its success or failure (if applicable), on the recovery of functions gastrointestinal, on perioperative management, on morbidity and mortality.
Patients have a follow-up consultation on D30 and D90 postoperative. Any morbidity, mortality or recurrence that occurred during this period is collected.
Patients are contacted by telephone after 12 months to ensure that no recurrence of aSBO has occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre randomized open-label controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard support | Active comparator | Procedure: Standard supportInitial medical treatment: placement of a nasogastric tube associated with hydration and vascular filling for hypovolaemic patients. Other medical treatments for occlusive small bowel syndrome on adhesion or flange can be performed but are not systematically recommended. Their use is left to the discretion of the surgeon. Medical treatment is carried out over 72 hours from admission. In case of resumption of a transit by gas and/or stools associated with a tolerance to the food, the exit is authorized without resorting to surgery. In the absence of a resumption of transit by gas and/or stools associated with tolerance to food, semi-urgent surgical management is proposed 72 hours from the start of management. In the event of deterioration of the clinical condition during hospitalization, urgent surgery will be proposed, according to the recommendations for use. |
| Early surgery proposed according to the radiological score | Experimental | Procedure: Early surgery proposed according to the radiological scorePatients included in the experimental arm have treatment adapted to the radiological score. The radiological score described by Berge et al. (Berge et al. Eur J Trauma Emerg Surg 2021) is calculated after patient inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission for acute intestinal obstruction of the small intestine on adhesion or bridle
- Confirmation of the aSBO by a scanner
- Adult patient
- Beneficiary of a social security scheme
- Having signed an informed consent
Key exclusion criteria (7 listed)
- Indication for urgent surgery (small intestine ischemia, intestinal pain, defence, hemodynamic shock, etc.)
- Pregnancy or breastfeeding
- Poor understanding of the French language
- Person deprived of liberty by judicial or administrative decision
- Person undergoing psychiatric treatment under duress
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 |
|---|---|---|
| Standard supportSee arm/group descriptions | Procedure or surgery | Standard support |
| Early surgery proposed according to the radiological score* If score ≥ 5: the risk of medical treatment failure is multiplied by 2.9 (Feuerstoss F et al, J Gastrointest Surg 2021). Early surgical treatment is proposed; that is, the procedure is performed within 24 hours of admission. The surgery is initiated by laparoscopy and converted to open surgery if necessary. * If score < 5: the risk of medical treatment failure is reduced. Initial medical treatment is therefore offered in accordance with standard management. | Procedure or surgery | Early surgery proposed according to the radiological score |
Primary outcome
90-day morbidity and mortality of aSBO management using the radiological score
Time frame: 90 days
The main objective is to evaluate the effectiveness, in terms of 90-day morbidity and mortality, of management of uncomplicated aSBO based on the use of the radiological score as a tool to select patients eligible for early surgery. compared to standard care (medical treatment for 72 hours).
6 secondary outcomes
Morbidity and mortality at 30 days
Time frame: 30 days
Length of patient hospitalization
Time frame: assessed to 2 days
Recurrence rate of aSBO
Time frame: one year
Rate of recourse to surgery for patients not operated on straight away
Time frame: One year
Surgical morbidity and mortality at 30 days of patients operated on during the first hospitalization
Time frame: 30 days
Laparoscopic surgery rate
Time frame: Surgery time assessed to 1 hour
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 13 Jun 2024.
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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.
Cécile Jaglin-Grimonprez study director
University hospital of Angers
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard support and Early surgery proposed according to the radiological score in people with Small Bowel Obstruction, run by University Hospital, Angers at 14 sites 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 5 inclusion and 7 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 Paul Le Naoures, Dr ((0)2 41 35 49 16 ext. 33, Paul.LeNaoures@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day morbidity and mortality of aSBO management using the radiological score (time frame: 90 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 13 Jun 2024.