Study on the Safety and Efficacy of Domestic Single-Port Robot-Assisted Metabolic Bariatric Surgery.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-10

Study Completion Date

2027-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Robot Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic surgical treatment group

Group Type EXPERIMENTAL

Robot-assisted single-port bariatric surgery

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No