Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.

Exploratory Study on the Application of Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.

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

Study Overview

• Status: Recruiting
• Conditions: Gynecological Cancer
• Intervention / Treatment: Procedure: Laparoscopic surgery

Detailed Description

This clinical study adopts a prospective, single-center, single-arm exploratory design. Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.

The research process consists of three stages: the screening phase, the treatment phase and the follow-up phase. The screening phase: On the premise of meeting the inclusion and exclusion criteria, patients who voluntarily participate in robot-assisted surgery are planned to be included. Obtain written informed consent from the subjects, collect clinical data (which may include previous medical examination results), and complete relevant examinations. The treatment phase: The laparoscopic surgical system is combined with 5G network and communication technology for the surgical operation process. The follow-up phase: The physician's observational follow-up of the subjects in the study will continue up to one month post-surgery, and may be extended if necessary. During these three phases, subjects will need to undergo some medical observations or examinations to assess safety and efficacy indicators.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minhui Hua, M.D.; Phone Number: 051385052222 13773631198; Email: mh_hua@ntu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Minhui Hua; Phone Number: 86-13773631198; Email: mh_hua@ntu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who require endoscopic surgery
• Voluntarily participate in this study and sign informed consent in writing

Exclusion Criteria:

• 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
• Participated in other clinical trials in the past 1 month
• Inability to understand trial requirements, or inability to complete the study follow-up plan
• Other conditions that are considered by the investigator to be inappropriate for enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: laparoscopic surgical systems; Using the Toumai laparoscopic surgical system for gynecological surgical treatment, and combining with 5G communication technology to carry out remote surgical treatment.	Procedure: Laparoscopic surgery; The laparoscopic surgery system is applied to gynecology and 5G remote surgical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the enrollment of all subjects to one month post-surgery, assessed up to 6 months.

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: Minhui Hua, M.D., Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: gynecological; Laparoscopic Surgical; Telesurgery
• Other Study ID Numbers: huaminhui

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No