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NCT Number: NCT07335731

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

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.

Recruiting

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Robot Surgery Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Robot-assisted single-port bariatric surgery

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.

Primary outcomes

  1. Percentage of weight loss

    Time frame: Postoperative 1 month, 3 months, 6 months, 12months

Secondary outcomes

  1. blood pressure

    Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery

  2. operation time

    Time frame: Intraoperative

  3. Postoperative complications (postoperative bleeding, gastric leakage, anastomotic leakage, abdominal infection, incisional hernia, etc.)

    Time frame: 12 months post-surgery

  4. Physician fatigue level (Visual Analogue Scale)

    Time frame: 1 day after surgery

  5. blood sugar

    Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery

  6. body fat percentage

    Time frame: 1 month, 3 months, 6 months, and 12 months post-surgery

  7. estimated blood loss

    Time frame: 1 month after surgery

  8. conversion to laparoscopic or open surgery

    Time frame: 1 month after surgery

  9. 30-day reoperation rate

    Time frame: 1 month after surgery

  10. 30-day readmission rate

    Time frame: 1 month after surgery

  11. length of postoperative hospital stay

    Time frame: 1 month after surgery

  12. Physician satisfaction level (Net Promoter Score, NPS)

    Time frame: 1 day after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

SIQi Wang

CONTACT

[email protected]

18810315722

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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