Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorAffiliated Hospital of Nantong University

About this trial

Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who require endoscopic surgery

Voluntarily participate in this study and sign informed consent in writing

Disqualifiers

Patients with malignant tumors with clinical stage IV

Those who require emergency surgery

Presence of active bleeding, severe abnormal coagulopathy (prothrombin time (PT) or international normalized ratio (INR) greater than 1.5 times the upper limit of normal), or platelet count < 80×10^9/L

Patient has severe cardiovascular or circulatory disease and cannot tolerate surgery

Trial design

Design model

Single group

Treatments tested in this trial

  • Laparoscopic surgery

    Procedure/Surgery

    The laparoscopic surgery system is applied to gynecology and 5G remote surgical treatment.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: laparoscopic surgical systemsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

surgical complications

The Satava classification system is used to evaluate intraoperative complications: Level Ⅰ: No impact on the patient, no treatment required or only conservative treatment is needed. Level Ⅱ: The mistake is immediately recognized and corrected, with no serious consequences. Level Ⅲ: The mistake is not recognized, leading to serious consequences. The Clavien-Dindo classification system is used to assess postoperative complications: Grade Ⅰ: Abnormal situations that do not require drug treatment or surgical, endoscopic, or radiologic intervention. Grade Ⅱ: Complications requiring drug treatment, but not requiring surgery, endoscopy, or radiologic intervention. Grade Ⅲ: Complications requiring surgical, endoscopic, or radiologic intervention, with Ⅲa not requiring general anesthesia and Ⅲb requiring general anesthesia. Grade Ⅳ: Life-threatening complications requiring ICU management, with Ⅳa for single-organ dysfunction and Ⅳb for multiple organ dysfunction. Grade Ⅴ: Death.

Time frame
From the enrollment of all subjects to one month post-surgery, assessed up to 6 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

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