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Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.
Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic sleeve gastrectomy | Active Comparator | Patients undergoing traditional sleeve gastrectomy |
|
| Robotic sleeve gastrectomy | Active Comparator | Sleeve gastrectomy with DaVinci robot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve gastrectomy | Procedure | Sleeve gastrectomy with laparoscopic or robotic approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time in minutes (Docking plus console time for the robotic procedures) | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding | Bleeding during the surgical procedure | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich |
| Postoperative bleeding | Bleeding after the end of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Naples | Italy | 80131 | Italy |
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| From the end of the procedure to postoperative day 30 |
| Conversion to Laparoscopy | Conversion to laparoscopy | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich |
| Conversion to Laparotomy | Conversion to laparotomy | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich |
| Postoperative Leak | Leak from the staple line | From the end of the procedure to postoperative day 30 |
| Postoperative Bowel Obstruction | Bowel obstruction | From the end of the procedure to postoperative day 30 |
| Postoperative nausea | Postoperative nausea measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable nausea) | From the end of the procedure to postoperative hour 24 |
| Postoperative vomit | Postoperative vomit measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable vomit) | From the end of the procedure to postoperative hour 24 |