Exploratory Study of Single-port Robot-assisted Gastrectomy

Not Applicable

Not yet recruiting

• Conditions: Gastric Cancer
• Interventions: Device: SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

• Registration Number: NCT06201585
• Lead Sponsor: Hebei Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2023-12-30
• Last Update Submitted: 2023-12-30
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Study Start: 2024-02-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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'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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-port robot-assisted gastrectomy	SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)	SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

Primary Outcome Measures

Name	Time	Method
The rate of intraoperative complications	The day of surgery	Intraoperative complications, including organ injury and vascular injury, were evaluated
The rate of postoperative complications	Postoperative 30 days	Postoperative complications, including postoperative bleeding, fever, and incisional infection, were evaluated using the Clavien-Dindo grading system to determine whether the occurrence of complications was related to the study instrument or surgery.

Trial Locations

Locations (1)

Department of General Surgery; 🇨🇳 Shijiazhuang, Hebei, China