Robotic Versus Laparoscopic Sleeve Gastrectomy
ConditionRobotic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Naples
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines
Disqualifiers
Previous bariatric or abdominal surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Sleeve gastrectomy
Procedure/SurgerySleeve gastrectomy with laparoscopic or robotic approach
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Laparoscopic sleeve gastrectomyActive comparator 1 intervention
Group B: Robotic sleeve gastrectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Operative time
Operative time in minutes (Docking plus console time for the robotic procedures)
Time frame
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stichSecondary outcomes
1
Intraoperative bleeding
Bleeding during the surgical procedure
Time frame
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich2
Postoperative bleeding
Bleeding after the end of the procedure
Time frame
From the end of the procedure to postoperative day 303
Conversion to Laparoscopy
Conversion to laparoscopy
Time frame
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich4
Conversion to Laparotomy
Conversion to laparotomy
Time frame
From the Veress needle insertion at the beginning of the surgical intervention to the last skin stichSponsors and contacts
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Source ClinicalTrials.gov