Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
The laparoscopic surgery system is applied to gynecology and 5G remote surgical treatment.
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGsurgical 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.
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