Robotic Versus Laparoscopic Sleeve Gastrectomy

University of Naples50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Robotic Surgery

Interventions

Sleeve gastrectomyPROCEDURE

Sleeve gastrectomy with laparoscopic or robotic approach

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Naples Federico II

Naples, Italy, Italy

RECRUITING

Outcomes

Primary Outcomes

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 stich

Secondary Outcomes

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 stich

Postoperative bleeding

Bleeding after the end of the procedure

Time frame: From the end of the procedure to postoperative day 30

Conversion to Laparoscopy

Conversion to laparoscopy

Time frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich

Conversion to Laparotomy

Conversion to laparotomy

Time frame: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich

Postoperative Leak

Leak from the staple line

Time frame: From the end of the procedure to postoperative day 30

Postoperative Bowel Obstruction

Bowel obstruction

Time frame: 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)

Central Contacts

Antonio Vitiello, MD PhD

CONTACT

0039 0817462792 antoniovitiello_@hotmail.it

Data from ClinicalTrials.gov

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