Recruiting NCT07335731
Study on the Safety and Efficacy of Domestic Single-Port Robot-Assisted Metabolic Bariatric Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-assisted single-port bariatric surgery.
- Who it may be relevant to
- Registry conditions: Obesity, Robot Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to obtain short-term clinical results on the safety and efficacy of single-port robot-assisted metabolic weight loss surgery, and to provide further evidence for the clinical promotion of single-port robot systems.
Interventions
- Device Robot-assisted single-port bariatric surgery
For overweight or obese patients (BMI≥27.5kg/m2) who meet the indications for metabolic surgery, single-port robot-assisted sleeve gastrectomy or gastric bypass surgery is performed.
Primary outcome measures
- Percentage of weight loss [Time frame: Postoperative 1 month, 3 months, 6 months, 12months]
Secondary outcome measures (12)
- blood pressure [Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery]
- operation time [Time frame: Intraoperative]
- Postoperative complications (postoperative bleeding, gastric leakage, anastomotic leakage, abdominal infection, incisional hernia, etc.) [Time frame: 12 months post-surgery]
- Physician fatigue level (Visual Analogue Scale) [Time frame: 1 day after surgery]
- blood sugar [Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery]
- body fat percentage [Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery]
- estimated blood loss [Time frame: 1 month after surgery]
- conversion to laparoscopic or open surgery [Time frame: 1 month after surgery]
- 30-day reoperation rate [Time frame: 1 month after surgery]
- 30-day readmission rate [Time frame: 1 month after surgery]
- length of postoperative hospital stay [Time frame: 1 month after surgery]
- Physician satisfaction level (Net Promoter Score, NPS) [Time frame: 1 day after surgery]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT07335731 · 2025-HX-177