Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots

Central South University

Status: Completed

Conditions: Rectal Cancer

Treatments: Device: Micro Hand S robot and da Vinci robot; Device: da Vinci robot

Study type: Interventional

Funder types: Other

Identifiers

NCT04855448

XY3-DSRCS1507A04

Details and patient eligibility

About

Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The Micro Hand S robot is safe and feasible in the preliminary study. However, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.

Full description

The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The safey and feasibility has been evaluated. However, the learning curve of this procedure is unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously are unclear.Therefore, this srudy is conducted to evaluate the learning curve of the two robots in low anterior resection.

Enrollment: 112 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed rectal cancer; ASA score ≤ 3

Exclusion criteria

• palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

Surgeon A

Experimental group

Description:

This group is consisted of 56 cases performed using the Micro Hand S robot and da Vinci robot by one single surgeon in low anterior resection for rectal cancer

Treatment:

Device: Micro Hand S robot and da Vinci robot

Surgeon B

Active Comparator group

Description:

This group is consisted of 56 cases performed using the da Vinci robot by one single surgeon in low anterior resection for rectal cancer

Treatment:

Device: da Vinci robot