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OpenTrials
Completed

NCT Number: NCT06629662

Robotic Versus Laparoscopic Sleeve Gastrectomy

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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Key information

Conditions

Robotic Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, Italy, 80131

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy

Procedure

Sleeve gastrectomy with laparoscopic or robotic approach

Primary outcomes

  1. Operative time

    Time frame: 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 outcomes

  1. Intraoperative bleeding

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

    Bleeding during the surgical procedure

  2. Postoperative bleeding

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

    Bleeding after the end of the procedure

  3. Conversion to Laparoscopy

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

    Conversion to laparoscopy

  4. Conversion to Laparotomy

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

    Conversion to laparotomy

  5. Postoperative Leak

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

    Leak from the staple line

  6. Postoperative Bowel Obstruction

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

    Bowel obstruction

  7. Postoperative nausea

    Time frame: 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)

  8. Postoperative vomit

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Naples

Other

Registry information

Official study title

Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.

Acronym: SLEEVEROBOP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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