Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic surgery.
- Who it may be relevant to
- Registry conditions: Gynecological Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploratory Study on the Application of Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.
Overview
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.
Interventions
- Procedure Laparoscopic surgery
The laparoscopic surgery system is applied to gynecology and 5G remote surgical treatment.
Primary outcome measures
- surgical complications [Time frame: From the enrollment of all subjects to one month post-surgery, assessed up to 6 months.]
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 \< 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Hospital of Nantong University — Nantong
Identifiers
NCT: NCT06676267 · huaminhui