Clinical trial NCT06201585: Exploratory Study of Single-port Robot-assisted Gastrectomy
Official title: Single-port Robot-assisted Surgery for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 10
Sex: ALL
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: 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 robot-assisted gastrectomy, and explore and evaluate the safety and efficacy of this clinical application.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old and age ≤80 years old, regardless of gender;
2. patients who met the surgical indications and were confirmed by the investigator to be in need of laparoscopic surgery.
3. patients with American Society of Anesthesiologists (ASA) physical status classification ⅰ-ⅲ.
4. Be able to cooperate with the completion of visits and related examinations specified in the protocol.
5. Subjects voluntarily participated in the clinical trial and agreed or their guardians agreed to sign an informed consent.

Exclusion Criteria:

1. patients with severe heart, lung, brain, liver, or kidney diseases can not tolerate surgery or anesthesia;
2. those who cannot tolerate pneumoperitoneum;
3. patients with serious systemic diseases that are not suitable for surgical treatment according to the judgment of the investigator;
4. 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);
5. patients with active pulmonary tuberculosis;
6. 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;
7. with epilepsy, psychiatric history or cognitive impairment;
8. pregnant and lactating women;
9. 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\&#39;s judgment Situations where there is a risk of extensive adhesion;
10. participants who participated in other interventional clinical trials within 3 months before screening;
11. other circumstances that the investigator deemed inappropriate to participate in the trial.

Primary outcomes:
measure: The rate of intraoperative complications
timeFrame: The day of surgery
measure: The rate of postoperative complications
timeFrame: Postoperative 30 days
Secondary outcomes:
Other outcomes:
measure: Intraoperative system failure rate
timeFrame: The day of surgery
measure: Surgical completion rate
timeFrame: The day of surgery
measure: Intraoperative blood loss
timeFrame: The day of surgery
measure: Operation time
timeFrame: The day of surgery
measure: Preoperative device assembly time
timeFrame: The day of surgery
measure: Intraoperative instrument operation error rate
timeFrame: The day of surgery
Locations:
city: Shijiazhuang
country: China
facility: Department of General Surgery
state: Hebei
Study officials:
References: