Clinical trial NCT06676267: Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.
Official title: Exploratory Study on the Application of Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecological Cancer
Keywords: Laparoscopic Surgical
gynecological
Telesurgery
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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 \&lt; 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

Primary outcomes:
measure: surgical complications
timeFrame: From the enrollment of all subjects to one month post-surgery, assessed up to 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Minhui Hua, M.D.
role: PRINCIPAL_INVESTIGATOR
References: