HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy with a New Platform

HUGO-SLEEVE: Evaluating the Feasibility of Robotic Sleeve Gastrectomy with a New Platform - HUGO-SLEEVE Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040512

Enrollment

Registered

2026-06-22

Start date

2026-06-04

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E66

Interventions

Group 1: 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 mas

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 years - Body mass index (BMI) = 40 kg/m², or BMI = 35 kg/m² in the presence of at least one obesity-related comorbidity - Scheduled for elective primary sleeve gastrectomy - Ability to provide written informed consent - Sufficient language proficiency to participate in the study.

Exclusion criteria

Exclusion criteria: - Previous upper abdominal surgery - Revisional bariatric surgery - American Society of Anesthesiologists (ASA) physical status classification = IV - Oral anticoagulation therapy - Presence of a ventriculoperitoneal shunt - Severe hepatomegaly or other contraindications to a robotic surgical approach

Design outcomes

Primary

Measure	Time frame
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. The endpoint is assessed intraoperatively during surgery (T1) based on standardized operative records and the study Case Report Form (CRF).	—

Secondary

Measure	Time frame
1. Port Placement Time What: Time interval from skin incision to initiation of robotic system setup and docking. When: During surgery (T1 = day of surgery). How: Measured in minutes using intraoperative time records and documented in the Case Report Form (CRF). 2. Docking Time What: Time interval from completion of port placement to console readiness. When: During surgery (T1 = day of surgery). How: Measured in minutes using intraoperative time records and documented in the CRF. 3. Console Time What: Duration of active use of the Hugo™ robotic surgical console. When: During surgery (T1 = day of surgery). How: Measured in minutes based on system and operative records and documented in the CRF. 4. Total Operative Time What: Time interval from skin incision to skin closure (skin-to-skin time). When: During surgery (T1 = day of surgery). How: Measured in minutes using standardized operative records and documented in the CRF. 5. Intraoperative Complications What: Occurrence of intraoperative complications, such as bleeding or stapling-related issues. When: During surgery (T1 = day of surgery). How: Assessed through operative reports and documented in the CRF. 6. Postoperative Complication Rate What: Occurrence of postoperative complications. When: Within 30 days after surgery (T2 = postoperative day 30). How: Assessed according to the Clavien–Dindo Classification based on clinical follow-up and structured telephone follow-up. 7. Length of Hospital Stay What: Duration of postoperative hospital stay. When: Assessed up to postoperative day 30 (T2 = POD30). How: Measured in days based on hospital records and documented in the CRF. 8. Readmission Rate What: Hospital readmission after sleeve gastrectomy. When: Within 6 months after surgery (T4 = postoperative day 180). How: Assessed through hospital records and structured telephone follow-up. 9. Reoperation Rate What: Requirement for reoperation following sleeve gastrectomy. When: With	—

Measure

Time frame

1. Port Placement Time What: Time interval from skin incision to initiation of robotic system setup and docking. When: During surgery (T1 = day of surgery). How: Measured in minutes using intraoperative time records and documented in the Case Report Form (CRF). 2. Docking Time What: Time interval from completion of port placement to console readiness. When: During surgery (T1 = day of surgery). How: Measured in minutes using intraoperative time records and documented in the CRF. 3. Console Time What: Duration of active use of the Hugo™ robotic surgical console. When: During surgery (T1 = day of surgery). How: Measured in minutes based on system and operative records and documented in the CRF. 4. Total Operative Time What: Time interval from skin incision to skin closure (skin-to-skin time). When: During surgery (T1 = day of surgery). How: Measured in minutes using standardized operative records and documented in the CRF. 5. Intraoperative Complications What: Occurrence of intraoperative complications, such as bleeding or stapling-related issues. When: During surgery (T1 = day of surgery). How: Assessed through operative reports and documented in the CRF. 6. Postoperative Complication Rate What: Occurrence of postoperative complications. When: Within 30 days after surgery (T2 = postoperative day 30). How: Assessed according to the Clavien–Dindo Classification based on clinical follow-up and structured telephone follow-up. 7. Length of Hospital Stay What: Duration of postoperative hospital stay. When: Assessed up to postoperative day 30 (T2 = POD30). How: Measured in days based on hospital records and documented in the CRF. 8. Readmission Rate What: Hospital readmission after sleeve gastrectomy. When: Within 6 months after surgery (T4 = postoperative day 180). How: Assessed through hospital records and structured telephone follow-up. 9. Reoperation Rate What: Requirement for reoperation following sleeve gastrectomy. When: With

—

Countries

Germany

Contacts

Public ContactGabriel Plitzko

Universitätsklinikum Hamburg-Eppendorf

g.plitzko@uke.de+4915222842144

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026