An interventional study of Sleeve Gastrectomy using Hugo RAS platform in Obesity (BMI > 35), Obesity (BMI > 35) and Diabetes Mellitus and Obesity (BMI > 35) and Dyslipemia, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
Severe obesity is a chronic condition that can lead to a range of serious health problems. One common treatment option is sleeve gastrectomy, a weight-loss operation in which the size of the stomach is reduced. These procedures are increasingly being performed with the support of robotic surgical systems. However, there is still limited clinical experience with the Hugo™ Robotic-Assisted Surgery System for this type of operation.
The aim of this study is to evaluate whether sleeve gastrectomy can be performed safely and reliably using the Hugo™ system. In particular, the study will assess whether the operation can be completed as planned with the robotic system and will examine outcomes during and after surgery.
The study will include 50 adults with severe obesity who are scheduled to undergo sleeve gastrectomy. Information will be collected during the operation, including the duration of different surgical steps and the occurrence of any complications. Participants will be followed for six months after surgery. During this period, information on pain, complications, hospital stays, readmissions, and quality of life will be collected. The study aims to provide important information about the safe introduction and use of the Hugo™ system for this established weight-loss procedure.
The HUGO-SLEEVE Trial is a prospective, single-center, single-arm interventional study designed to evaluate the feasibility and safety of robotic sleeve gastrectomy using the Hugo™ Robotic-Assisted Surgery System, including the LigaSure™ RAS vessel sealing device, during the early phase of clinical implementation. The study investigates whether the procedure can be performed safely and reliably.
The primary endpoint is the proportion of procedures completed without conversion. Secondary endpoints include intraoperative parameters (port placement time, docking time, console time, total operative time, and intraoperative complications) as well as postoperative outcomes (complications, length of hospital stay, readmissions, reoperations, postoperative pain, time to oral intake and mobilization, and changes in SF-Bari Score).
A total of 50 consecutive patients with a body mass index (BMI) ≥ 40 kg/m² or a BMI ≥ 35 kg/m² in the presence of at least one obesity-related comorbidity who are scheduled to undergo elective primary sleeve gastrectomy will be enrolled. Postoperative follow-up assessments will be performed on postoperative days 1, 2, 3, 30, 90, and 180.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 50 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
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Exclusion Criteria:
Elective primary sleeve gastrectomy performed using the Hugo™ Robotic-Assisted Surgery (RAS) system, including the LigaSure™ RAS vessel-sealing system, in patients with obesity and a body mass index (BMI) ≥ 40 kg/m² or a BMI ≥ 35 kg/m² in combination with at least one obesity-related comorbidity.
Device: Sleeve Gastrectomy using Hugo RAS platform
Elective primary sleeve gastrectomy performed using the Hugo™ Robotic-Assisted Surgery (RAS) system, including the LigaSure™ RAS vessel-sealing system, in patients with obesity and a body mass index (BMI) ≥ 40 kg/m² or a BMI ≥ 35 kg/m² in combination with at least one obesity-related comorbidity.
Proportion of robotic sleeve gastrectomy procedures successfully completed using the Hugo™ Robotic-Assisted Surgery (RAS) system including LigaSure™ RAS without intraoperative conversion to conventional laparoscopy or open surgery.
Time frame: From beginning to the end of the Procedure
Port Placement Time
Time interval from skin incision to initiation of robotic system setup and docking
Time frame: During surgery
Docking Time
Time interval from completion of port placement to console readiness
Time frame: During surgery
Console Time
Duration of active use of the Hugo™ robotic surgical console
Time frame: During surgery
Total Operative Time
Time interval from skin incision to skin closure (skin-to-skin time)
Time frame: During surgery
Intraoperative Complications
Occurrence of intraoperative complications, such as bleeding or stapling-related issues
Time frame: During surgery
Postoperative Complication Rate
Occurrence of postoperative complications
Time frame: Within 30 days after surgery
Length of Hospital Stay
Duration of postoperative hospital stay
Time frame: Assessed up to postoperative day 30
Readmission Rate
Hospital readmission after sleeve gastrectomy
Time frame: Within 6 months after surgery
Reoperation Rate
Requirement for reoperation following sleeve gastrectomy
Time frame: Within 6 months after surgery
Postoperative Pain
Patient-reported postoperative pain intensity
Time frame: Postoperative day 1, postoperative day 2, and postoperative day 3
Time to Oral Intake and Mobilization
Time to first oral intake and independent mobilization after surgery
Time frame: Postoperative day 1, postoperative day 2, and postoperative day 3
Health-Related Quality of Life
Change in health-related quality of life following bariatric surgery
Time frame: 3 months and 6 months after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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