Exploratory Study of Single-port Robot-assisted Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Single-port Robot-assisted Surgery for Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06201585
• Other study ID #: FUTURE-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2023
• Source: Hebei Medical University
• Contact: Yuan Tian
• Phone: 800-555-5555
• Email: tangy0767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?-?.

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)
SHURUI Endoscopic Surgical Robotic System (SR-ENS-600)

Locations

Country	Name	City	State
China	Department of General Surgery	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraoperative system failure rate		The day of surgery
Other	Surgical completion rate		The day of surgery
Other	Intraoperative blood loss		The day of surgery
Other	Operation time		The day of surgery
Other	Preoperative device assembly time		The day of surgery
Other	Intraoperative instrument operation error rate		The day of surgery
Primary	The rate of intraoperative complications	Intraoperative complications, including organ injury and vascular injury, were evaluated	The day of surgery
Primary	The rate of postoperative complications	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.	Postoperative 30 days