Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

Central South University

Status: Completed

Conditions: Rectal Cancer

Treatments: Device: Laparoscope; Device: Micro Hand S robot

Study type: Interventional

Funder types: Other

Identifiers

NCT04836741

XY3-DSRCS1507A02

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, compared with minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy for rectal cancer are unclear. Therefore, the investigators conduct this retrospective study to focus on this concern.

Enrollment: 105 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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105 participants in 2 patient groups

Micro Hand S robot-assisted surgery

Experimental group

Description:

This group is consisted of 40 cases performed using the Micro Hand S robot by one single surgeon for rectal cancer

Treatment:

Device: Micro Hand S robot

Laparoscopic surgery

Active Comparator group

Description:

This group is consisted of 65 cases performed using the laparoscope by one single surgeon for rectal cancer

Treatment:

Device: Laparoscope