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Table 1 Trial Monitoring Committee Surgical accreditation criteria

From: Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol

Number

Description of Criteria

1

The participating surgeon is a qualified gynecologic oncologists accredited by the Korean Society of Gynecologic Oncology

2

The participating surgeon performs a minimum of 10 documented major oncologic surgeries (cervix, endometrial, ovarian, or vulvar cancer) as the main surgeon per year.

3

The participating surgeon performs a minimum of 10 documented laparoscopic/robotic type B2 or C radical hysterectomy cases as the main surgeon per year.

4

The participating surgeon has attended the endoscopic surgical stapling device seminar with the hands-on workshop.

5

The participating surgeon has performed a minimum of 10 documented successful use of laparoscopic surgical stapling device as the main surgeon.

6

The participating surgeon submitted at least 1 unedited surgical video and the relevant operation record for approval by the TMC

- Surgical technique and tissue handling

- Competency in identification of proper anatomical structures and adequate dissection of pelvic spaces

- Surgical technique with respect to blood loss and prevention of intraoperative injury

- Appropriate and timely decision making based on intraoperative findings

- Appropriate use and selection of instrumentation for all parts of the procedure