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The objective of this randomized controlled trial is to compare perioperative outcomes between laparoscopic and robotic approaches in patients with severe obesity who are candidates for RYGB. The trial aims to address the following key questions:
To evaluate the difference between the two procedures in terms of postoperative complications.
To assess intraoperative complications, conversion rate, mortality, operative times, postoperative hospital stay, and cost analysis for both approaches.
In summary, the researchers will compare the laparoscopic and robotic approaches to determine which one leads to better perioperative outcomes
Treating patients with pathological obesity has always posed a challenge for bariatric surgeons due to their increased risk of post-operative complications and varying short-term outcomes depending on the chosen procedure. Currently, there are no established guidelines to dictate which procedure is optimal for a given clinical presentation. Surgeons typically make this decision based on their expertise and the patient's characteristics. The most frequently performed procedures worldwide are sleeve gastrectomy and Roux-en-Y gastric bypass, with the latter validated by numerous long-term studies as a safe and effective bariatric and metabolic option for patients with a BMI <50 kg/m2. However, the complexity of Roux-en-Y gastric bypass, which requires the creation of two anastomoses during the reconstruction phase, which might be challenging when performed laparoscopically, may be facilitated by a robotic approach. Although some studies suggest that these approaches have equivalent safety and efficacy profiles, conclusive evidence evaluating their economic impact remains elusive. Consequently, the objective of the present study is to compare morbidity between the laparoscopic and robotic approach in patients undergoing Roux-en-Y gastric bypass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic RYGB | Active Comparator | Patients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed laparoscopically. |
|
| Robotic RYGB | Experimental | Patients undergoing Roux-en-Y gastric bypass (RYGB) surgery performed using the DaVinci robotic platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic and robotic (DaVinci) RYGB | Device | Laparoscopic and robotic (DaVinci) Roux-en-Y Gastric Bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early complications rate | The percentage or proportion of individuals who experience adverse events or negative outcomes within a 30th day of time after hospital discharge | 30 Days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications rate | The percentage or proportion of individuals who experience adverse events or negative outcomes during surgical procedure. | From the beginning to the end of the surgical procedure |
| Conversions rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Pennestrì, Dr. | Contact | +393280244528 | francesco.pennestri@policlinicogemelli.it | |
| Marco Raffaelli, Prof. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Marco Raffaelli | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The percentage of individuals who start out undergoing a minimally invasive procedure but end up requiring a conversion to a more invasive procedure.
| From the beginning to the end of the surgical procedure |
| mortality rate | The percentage or proportion of individuals who die within a 30th day of time after hospital discharge | 30 days after hospital discharge |
| Operative time | The length of time a patient spends in the operating room undergoing a surgical procedure, from the start of the surgery to the completion of the procedure | From the beginning to the end of the surgical procedure |
| Length of hospital stay | The amount of time a patient spends in the hospital or medical facility after a surgical procedure has been performed. | up to 1 week |
| Costs of hospitalization and surgery | the expenses associated with medical care provided during a patient's stay in a hospital or medical facility, including surgical procedures. | up to 1 week |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |