Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.

NCT06676267 | Recruiting

• 1 other identifier: huaminhui
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gynecological Cancer

Keywords

Laparoscopic Surgical; gynecological; Telesurgery

Outcome Measures

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.

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

Study Arms (1)

laparoscopic surgical systems

EXPERIMENTAL

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

Interventions

Laparoscopic surgery PROCEDURE

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

laparoscopic surgical systems

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Minhui Hua, M.D.

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minhui Hua, M.D.

CONTACT

13773631198; mh_hua@ntu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: November 6, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2024-08

Locations

CN (1)