Robotic Surgery
Conditions
Keywords
Robotic surgery, Sleeve Gastrectomy, Bariatric surgery
Brief summary
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.
Interventions
PROCEDURESleeve gastrectomy
Sleeve gastrectomy with laparoscopic or robotic approach
Sponsors
University of Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines
Exclusion criteria
* Previous bariatric or abdominal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich | Operative time in minutes (Docking plus console time for the robotic procedures) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich | Bleeding during the surgical procedure |
| Postoperative bleeding | From the end of the procedure to postoperative day 30 | Bleeding after the end of the procedure |
| Conversion to Laparoscopy | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich | Conversion to laparoscopy |
| Conversion to Laparotomy | From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich | Conversion to laparotomy |
| Postoperative Leak | From the end of the procedure to postoperative day 30 | Leak from the staple line |
| Postoperative Bowel Obstruction | From the end of the procedure to postoperative day 30 | Bowel obstruction |
| Postoperative nausea | From the end of the procedure to postoperative hour 24 | Postoperative nausea measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable nausea) |
| Postoperative vomit | From the end of the procedure to postoperative hour 24 | Postoperative vomit measured with a Visuo Analogic Scale (VAS) from 0 (no nausea) to 10 (not tolerable vomit) |
Countries
Italy
Outcome results
None listed