Status:
UNKNOWN
Exploratory Study of Single-port Robot-assisted Gastrectomy
Lead Sponsor:
Hebei Medical University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This clinical study was a prospective, single-center, single-arm exploratory study. Subjects who meet the inclusion criteria will be enrolled in this study, where surgeons will perform single-port rob...
Eligibility Criteria
Inclusion
- Age ≥18 years old and age ≤80 years old, regardless of gender;
- patients who met the surgical indications and were confirmed by the investigator to be in need of laparoscopic surgery.
- patients with American Society of Anesthesiologists (ASA) physical status classification ⅰ-ⅲ.
- Be able to cooperate with the completion of visits and related examinations specified in the protocol.
- Subjects voluntarily participated in the clinical trial and agreed or their guardians agreed to sign an informed consent.
Exclusion
- patients with severe heart, lung, brain, liver, or kidney diseases can not tolerate surgery or anesthesia;
- those who cannot tolerate pneumoperitoneum;
- patients with serious systemic diseases that are not suitable for surgical treatment according to the judgment of the investigator;
- patients with a history of severe bleeding disease, hematopoietic dysfunction or coagulation dysfunction, who are not suitable for surgical treatment according to the judgment of the investigator, and long-term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were discontinued less than 1 week before surgery);
- patients with active pulmonary tuberculosis;
- HIV antibody positive; Hepatitis B surface antigen (HbsAg) positive and hepatitis B virus DNA (HBV-DNA) copy number higher than the detection limit or normal range; Hepatitis C virus (HCV) antibody positive; Patients with positive treponema pallidum antibody and high risk of infection judged by the researcher;
- with epilepsy, psychiatric history or cognitive impairment;
- pregnant and lactating women;
- Extensive and severe adhesion in the abdominal cavity caused the inability to perform puncture to establish pneumoperitoneum, and it was difficult to isolate and expose the lesion; A history of major abdominal surgery and abdominal radiotherapy were included, according to the investigator\'s judgment Situations where there is a risk of extensive adhesion;
- participants who participated in other interventional clinical trials within 3 months before screening;
- other circumstances that the investigator deemed inappropriate to participate in the trial.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06201585
Start Date
February 1 2024
End Date
August 1 2024
Last Update
January 11 2024
Active Locations (1)
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1
Department of General Surgery
Shijiazhuang, Hebei, China, 050011