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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05585437
Other study ID # FUGES-026
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 11, 2021
Est. completion date December 25, 2021

Study information

Verified date October 2022
Source Fujian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To prospectively evaluate the effect of the gastric cancer specialist training program of Fujian Medical University Union Hospital on laparoscopic gastric cancer surgery.


Description:

Laparoscopic gastric cancer surgery has the advantages of less trauma, quick postoperative recovery, less postoperative pain symptoms, less postoperative complications, and shorter average hospital stay. In addition, the surgical safety and oncological efficacy of laparoscopic radical gastrectomy for gastric cancer have been obtained. Confirmed by numerous clinical studies. However, due to the difficult operation, complex anatomy and high technical requirements of laparoscopic gastric cancer surgery, the operator needs to have rich experience in laparotomy, skilled laparoscopic operation skills, and the ability to actively prevent and deal with complications after surgery. Therefore, at this stage, laparoscopic radical gastrectomy for gastric cancer is only suitable for large hospitals with certain conditions, and it should be gradually carried out on the basis of chief surgeons with rich clinical experience in radical gastrectomy and skilled laparoscopic technical experience. The gastric cancer specialist training program (STP-LRG-1) of Fujian Medical University Affiliated Union Hospital (STP-LRG-1) has more than 9 years of trainee training experience. The effectiveness of STP-LRG-1 has not been prospectively evaluated, so this study aimed to prospectively evaluate whether STP-LRG-1 can improve the surgical skills of trainees and ultimately improve short-term outcomes for patients during and after surgery


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date December 25, 2021
Est. primary completion date December 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. The title of fellow physician or above, with experience in performing laparoscopic radical gastrectomy for gastric cancer independently or under supervision; 2. The hardware facilities and staffing of the operating room support the completion of laparoscopic gastric cancer surgery; 3. Surgical videos of laparoscopic radical gastrectomy before and after the training required for this study can be provided; 4. Clinicopathological data, intraoperative and postoperative short-term outcome data of the patients operated by the surgeon before and after training can be provided; 5. Informed consent Exclusion Criteria: 1. Refuse to carry out laparoscopic gastric cancer surgery; 2. Due to the limitations of equipment or policies, the unit cannot routinely carry out laparoscopic gastric cancer surgery; 3. Those who have not performed laparoscopic gastric cancer surgery within 1 month before participating in the training and cannot provide video; 4. Those who are not expected to perform laparoscopic gastric cancer surgery within 1 month after participating in the training; 5. Participate in other clinical investigators during the same period.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
gastric cancer specialist training program
The gastric cancer specialist training program includes technical training and non-technical training. The technical training includes 1. The whole process of laparoscopic gastric cancer surgery technical teaching 2. Operation practice 3. Operation video review, non-technical training includes 1. Difficult case discussion 2. Specialists Session 3. Lymph node sorting training.

Locations

Country Name City State
China Fujian Medical University Union Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient complication rate Rate of reduction in surgical patient complications after trainee training one year
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