Robotic Versus Laparoscopic Sleeve Gastrectomy

Not Applicable

Recruiting

• Conditions: Robotic Surgery
• Interventions: Procedure: Sleeve gastrectomy

• Registration Number: NCT06629662
• Lead Sponsor: University of Naples

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Submitted: 2025-03-29
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic sleeve gastrectomy	Sleeve gastrectomy	Patients undergoing traditional sleeve gastrectomy
Robotic sleeve gastrectomy	Sleeve gastrectomy	Sleeve gastrectomy with DaVinci robot

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy