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NCT Number: NCT06676267

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location status: Recruiting

Location contact

Minhui Hua

CONTACT

[email protected]

86-13773631198

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Laparoscopic surgery

Procedure

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

Primary outcomes

  1. surgical complications

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

    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.

Study contacts

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

Minhui Hua, M.D.

CONTACT

[email protected]

13773631198 ext. 051385052222

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 6, 2024
Registry last updated
Jan 28, 2025

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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