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

NCT04855448 | Completed DMC

• 1 other identifier: XY3-DSRCS1507A04
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (3)

• learning curve of console time

  It was defined the cumulative sum plot of the consloe time in the chronological order.

  up to 1 week after operation

• learning curve of docking time

  It was defined the cumulative sum plot of the docking time in the chronological order.

  up to 1 week after operation

• learning curve of surgicla failure

  It was defined the cumulative sum plot of the docking time in the chronological order.

  up to 1 week after operation

Secondary Outcomes (18)

• Type of surgical procedure

  up to 1 week after operation

• Operative time (min)

  up to 1 week after operation

• Console time (min)

  up to 1 week after operation

• Docking time (min)

  up to 1 week after operation

• Conversion

  up to 1 week after operation

Study Arms (2)

Surgeon A

EXPERIMENTAL

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

Device: Micro Hand S robot and da Vinci robot

Surgeon B

ACTIVE COMPARATOR

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

Device: da Vinci robot

Interventions

Micro Hand S robot and da Vinci robot DEVICE

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

Surgeon A

da Vinci robot DEVICE

The surgeries are performed with the da Vinci robot

Surgeon B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed rectal cancer; ASA score ≤ 3

You may not qualify if:

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

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: May 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: October 31, 2019
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)