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

NCT ID: NCT04855448

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-10-31

Brief Summary

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.

Detailed 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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgeon A

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

Group Type: EXPERIMENTAL

Micro Hand S robot and da Vinci robot

Intervention Type: DEVICE

The surgeries are performed with the Micro Hand S robot and da Vinci robot

Surgeon B

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

Group Type: ACTIVE_COMPARATOR

da Vinci robot

Intervention Type: DEVICE

The surgeries are performed with the da Vinci robot

Interventions

Micro Hand S robot and da Vinci robot

The surgeries are performed with the Micro Hand S robot and da Vinci robot

Intervention Type: DEVICE

da Vinci robot

The surgeries are performed with the da Vinci robot

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

XY3-DSRCS1507A04

Identifier Type: -

Identifier Source: org_study_id