Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic sleeve gastrectomy using 48-Fr bougie | Experimental | Patients will undergo laparoscopic sleeve gastrectomy with a 48-Fr (16 mm) 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic sleeve gastrectomy using 48-Fr bougie | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative gastric leak rate | Postoperative gastric leak rate during the first month following the procedure will be proven either on:
| 30 days following the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity rate | Postoperative morbidity rate will be calculated regarding any complication occurring 90 days following the procedure. | 90 days following the procedure |
| Short-term weight loss |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadrien TRANCHART, Dr | Contact | (+33)145374037 | hadrien.tranchart@aphp.fr | |
| Ibrahim DAGHER, Pr | Contact | (+33)145374143 | ibrahim.dagher@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hadrien TRANCHART, Dr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Ambroise Paré | Suspended | Boulogne-Billancourt | 92104 | France | ||
| Hôpital Côte de Nacre CHU de Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34781991 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Laparoscopic sleeve gastrectomy using standard care bougie | Procedure | 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. |
|
Short-term weight loss will be assessed by calculation of excess weight loss at 3 and 6 months after the procedure.
| 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. | 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) | At 3 months, 6 months, 1 year and 2 years after the procedure |
| Withdrawn |
| Caen |
| 14033 |
| France |
| CHU Antoine Béclère | Recruiting | Clamart | 92140 | France |
|
| Centre hospitalier Intercommunal de Créteil | Withdrawn | Créteil | 94010 | France |
| Hôpital MICHALLON, CHU de Grenoble | Withdrawn | La Tronche | 38700 | France |
| Hôpital Dupuytren - Limoges | Withdrawn | Limoges | 87042 | France |
| Clinique de l'Yvette | Recruiting | Longjumeau | 91120 | France |
|
| Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat | Recruiting | Paris | 75018 | France |
|
| CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye | Recruiting | Poissy | 78300 | France |
|
| CH Saint-Denis | Recruiting | Saint-Denis | 93200 | France |
|
| Clinique Mutualiste Chirurgicale | Withdrawn | Saint-Etienne | 42100 | France |
| Hôpitaux de Brabois | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |