Health TrialsbyHealthPanel

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

ConditionsObesityRobot Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina-Japan Friendship Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Robotic surgical treatment groupExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
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