Safety and effectiveness of single-port robot-assisted weight-loss surgery
Study on the Safety and Efficacy of Domestic Single-Port Robot-Assisted Metabolic Bariatric Surgery.
NA · China-Japan Friendship Hospital · NCT07335731
This trial will test whether single-port robot-assisted weight-loss surgery is safe and effective for adults with obesity who meet criteria for metabolic surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital (other) |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07335731 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study at China-Japan Friendship Hospital will perform single-port robot-assisted metabolic (bariatric) operations and collect short-term clinical outcomes on safety and effectiveness. Eligible patients are adults with BMI ≥27.5 kg/m2 who meet local criteria for metabolic weight-loss surgery, can tolerate general anesthesia, and provide informed consent. The study will record intraoperative metrics, complication rates, early weight loss, and recovery measures during the immediate postoperative follow-up. Results are intended to provide further evidence to support clinical adoption of domestic single-port robotic systems.
Who should consider this trial
Good fit: Adults with obesity who meet metabolic surgery criteria (BMI ≥27.5 kg/m2), can tolerate general anesthesia, and agree to sign informed consent are ideal candidates.
Not a fit: Patients who are pregnant, have severe heart, lung, or liver dysfunction, serious coagulation disorders, active tumors, extensive abdominal adhesions, or are otherwise judged unsuitable (including BMI >50 kg/m2 as a relative contraindication) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the procedure could provide a less invasive option with similar weight-loss results while potentially reducing complications and speeding recovery.
How similar studies have performed: Robotic and single-incision laparoscopic bariatric procedures have shown feasibility and acceptable short-term outcomes in small series, but single-port robotic systems are relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ①Overweight or obese patients who meet the criteria for metabolic weight loss surgery, with a BMI ≥ 27.5 kg/m2; ② Patients who understand the purpose of the trial, voluntarily participate in the trial, and sign an informed consent form. Exclusion Criteria: * ① Patients who cannot tolerate general anesthesia, such as those with severe heart, lung, or liver dysfunction; ② Patients with severe coagulation disorders; ③ Pregnant patients; ④ Patients with concurrent tumors; ⑤ Patients with extensive and severe abdominal adhesions that prevent the establishment of pneumoperitoneum; ⑥ A BMI \> 50 kg/m² is a relative contraindication; ⑦ Patients deemed unsuitable for participation in this trial by any other investigator.
Where this trial is running
Beijing
- China-Japan Friendship Hospital — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: SIQi Wang
- Email: menghuade@hotmail.com
- Phone: 18810315722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Robot Surgery