Obesity, Robot Surgery
Conditions
Brief summary
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
DEVICERobot-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.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of weight loss | Postoperative 1 month, 3 months, 6 months, 12months |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure | 1 month, 3 months, 6 months, and 12 months post-surgery |
| operation time | Intraoperative |
| Postoperative complications (postoperative bleeding, gastric leakage, anastomotic leakage, abdominal infection, incisional hernia, etc.) | 12 months post-surgery |
| Physician fatigue level (Visual Analogue Scale) | 1 day after surgery |
| blood sugar | 1 month, 3 months, 6 months, and 12 months post-surgery |
| body fat percentage | 1 month, 3 months, 6 months, and 12 months post-surgery |
| estimated blood loss | 1 month after surgery |
| conversion to laparoscopic or open surgery | 1 month after surgery |
| 30-day reoperation rate | 1 month after surgery |
| 30-day readmission rate | 1 month after surgery |
| length of postoperative hospital stay | 1 month after surgery |
| Physician satisfaction level (Net Promoter Score, NPS) | 1 day after surgery |
Countries
China
Contacts
CONTACTSIQi Wang
Outcome results
None listed