Morbid ObesityBOUSTNCT02937649
Bougie Sleeve Trial
A study testing Laparoscopic sleeve gastrectomy using 48-Fr bougie in people with Morbid Obesity, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
Trial summary
Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Laparoscopic sleeve gastrectomy using 48-Fr bougie
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,658 participants
- Where
- 12 sitesFrance
- Study dates
- 8 Oct 2020to 8 Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 70 years
- Sleeve gastrectomy as a primary bariatric procedure
- Body Mass Index (BMI) > 40 kg/m² or > 35 kg/m² associated with at least one comorbidity susceptible to improve after surgery (including arterial hypertension, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, incapacitating osteo-articular disorders, non alcoholic steatohepatitis)
- Decision for intervention after multidisciplinary discussion
- Written informed consent
Who cannot join
- Previous upper abdominal surgery (cholecystectomy excepted)
- ASA (American Society of Anesthesiologists) score > 3
- Ongoing pregnancy or breast feeding
- Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures)
- Coagulation disorder
- Patient not covered by social security service and patient on AME
Show all 9Show fewer
- Patient under legal guardianship and trusteeship
- Patient with known silicon allergy (calibration bougie contains medical silicon)
- More generally, all other contraindications to the use of esophageal bougie MID-TUBE that have been the subject of a scientific paper or have been identified by the practitioner or practitioners
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 6 recruiting
- Suspended
Hôpital Ambroise Paré
Boulogne-Billancourt, 92104
- Withdrawn
Hôpital Côte de Nacre CHU de Caen
Caen, 14033
- Recruiting
CHU Antoine Béclère
Clamart, 92140
Hadrien TRANCHART, Dr, hadrien.tranchart@aphp.fr
- Withdrawn
Centre hospitalier Intercommunal de Créteil
Créteil, 94010
- Withdrawn
Hôpital MICHALLON, CHU de Grenoble
La Tronche, 38700
- Withdrawn
Hôpital Dupuytren - Limoges
Limoges, 87042
- Recruiting
Clinique de l'Yvette
Longjumeau, 91120
Aziz KARAA, Dr
- Recruiting
Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat
Paris, 75018
Tigran POGHOSYAN, Dr
- Recruiting
CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye
Poissy, 78300
Antonio D'ALESSANDRO, Dr
- Recruiting
CH Saint-Denis
Saint-Denis, 93200
Jean-Marc CATHELINE
- Withdrawn
Clinique Mutualiste Chirurgicale
Saint-Etienne, 42100
- Recruiting
Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500
Laurent BRUNAUD, Dr
About this study
Official title: Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate
Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.
Read the detailed description
Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.
The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss.
- Conditions
- Morbid Obesity
- Being tested
- Laparoscopic sleeve gastrectomy using 48-Fr bougie, Laparoscopic sleeve gastrectomy using standard care bougie
- Keywords
- Obesity, Bariatric surgery, Sleeve gastrectomy, Staple-line Leak, Bougie, Calibration
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomy using 48-Fr bougieProcedure or surgery
After gastric mobilization, the 48-Fr bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
Laparoscopic sleeve gastrectomy using standard care bougieProcedure or surgery
After gastric mobilization, the standard care bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sleeve gastrectomy using 48-Fr bougie | Experimental | Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie Receives: Procedure: Laparoscopic sleeve gastrectomy using 48-Fr bougie |
| Laparoscopic sleeve gastrectomy using standard care bougie | Active comparator | Patients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr) Receives: Procedure: Laparoscopic sleeve gastrectomy using standard care bougie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative gastric leak rate
Postoperative gastric leak rate during the first month following the procedure will be proven either on:
- Morphologic examination (with contrast ingestion)
- Blue dye test during surgical reintervention or postoperative course
- Contrast opacification during endoscopy
Measured: 30 days following the procedure
Secondary outcomes (4)
Postoperative morbidity rate
Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure.
Measured: 90 days following the procedure
Short-term weight loss
Short-term weight loss will be assessed by calculation of excess weight loss at 3 and 6 months after the procedure.
Measured: At 3 and 6 months after the procedure
Mid-term weight loss
Mid-term weight loss will be assessed by calculation of excess weight loss at 1 and 2 years after the procedure.
Measured: At 1 and 2 years after the procedure
Quality of life related to health
Quality of life related to health will be assessed at 3 months, 6 months, 1 year and 2 years after the procedure with the validated GIQLI scale (Gastro Intestinal Quality of Life Index)
Measured: At 3 months, 6 months, 1 year and 2 years after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start8 Oct 2020
- Primary completion8 Jun 2025 (estimated)
- Study completion8 Sep 2027 (estimated)
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 Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadrien TRANCHART, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937649
- Sponsor's protocol ID
- P150933
- Acronym
- BOUST
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2016
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaillard M, Lainas P, Agostini H, Dagher I, Tranchart H. Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial. Trials. 2021 Nov 15;22(1):806. doi: 10.1186/s13063-021-05734-3.
PubMed 34781991
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate
- ClinicalTrials.gov ID
- NCT02937649
- Acronym / sponsor ID
- BOUST / P150933
- Conditions
- Morbid Obesity
- Keywords
- Obesity, Bariatric surgery, Sleeve gastrectomy, Staple-line Leak, Bougie, Calibration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,658 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 8 Jun 2025 (estimated)
- Study completion
- 8 Sep 2027 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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.
Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.
Detailed description
Laparoscopic sleeve gastrectomy (LSG) has become an increasing bariatric procedure. The most common complication is gastric leak from the staple line, observed in approximately 3% of cases, and can result in long and incapacitating treatment. The diameter of the bougie used to calibrate the remnant stomach could impact the rate of gastric leak, a higher diameter being correlated with a lower risk of leak, without lowering long-term weight loss.
The aim of this prospective randomized trial is to compare the outcomes of LSG according to the use of a standard care bougie calibre or 48-Fr on postoperative gastric leak and mid-term weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sleeve gastrectomy using 48-Fr bougie | Experimental | Procedure: Laparoscopic sleeve gastrectomy using 48-Fr bougiePatients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) bougie |
| Laparoscopic sleeve gastrectomy using standard care bougie | Active comparator | Procedure: Laparoscopic sleeve gastrectomy using standard care bougiePatients will undergo laparoscopic sleeve gastrectomy with a standard care bougie (34, 36 or 38-Fr) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients between 18 and 70 years
- Sleeve gastrectomy as a primary bariatric procedure
- Body Mass Index (BMI) > 40 kg/m² or > 35 kg/m² associated with at least one comorbidity susceptible to improve after surgery (including arterial hypertension, obstructive sleep apnea syndrome and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes, incapacitating osteo-articular disorders, non alcoholic steatohepatitis)
- Decision for intervention after multidisciplinary discussion
- Written informed consent
Key exclusion criteria (9 listed)
- Previous upper abdominal surgery (cholecystectomy excepted)
- ASA (American Society of Anesthesiologists) score > 3
- Ongoing pregnancy or breast feeding
- Esophagus pathology or disorder (esophageal varices, esophageal diverticula, esophageal tumors, esophageal strictures)
- Coagulation disorder
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 |
|---|---|---|
| Laparoscopic sleeve gastrectomy using 48-Fr bougieAfter gastric mobilization, the 48-Fr bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie. | Procedure or surgery | Laparoscopic sleeve gastrectomy using 48-Fr bougie |
| Laparoscopic sleeve gastrectomy using standard care bougieAfter gastric mobilization, the standard care bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie. | Procedure or surgery | Laparoscopic sleeve gastrectomy using standard care bougie |
Primary outcome
Postoperative gastric leak rate
Time frame: 30 days following the procedure
Postoperative gastric leak rate during the first month following the procedure will be proven either on: * Morphologic examination (with contrast ingestion) * Blue dye test during surgical reintervention or postoperative course * Contrast opacification during endoscopy
4 secondary outcomes
Postoperative morbidity rate
Time frame: 90 days following the procedure
Short-term weight loss
Time frame: At 3 and 6 months after the procedure
Mid-term weight loss
Time frame: At 1 and 2 years after the procedure
Quality of life related to health
Time frame: At 3 months, 6 months, 1 year and 2 years after the procedure
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 6 Apr 2025.
- Derived from this study: PubMed 34781991Gaillard M, Lainas P, Agostini H, Dagher I, Tranchart H. Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial. Trials. 2021 Nov 15;22(1):806. doi: 10.1186/s13063-021-05734-3.
- 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.
Hadrien TRANCHART, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sleeve gastrectomy using 48-Fr bougie in people with Morbid Obesity, run by Assistance Publique - Hôpitaux de Paris at 12 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 9 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 Hadrien TRANCHART, Dr ((+33)145374037, hadrien.tranchart@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative gastric leak rate (time frame: 30 days following the procedure). 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 NCT02937649, 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 6 Apr 2025.