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

Accelerated Learning Curve in Low Anterior Resection for Rectal Resection, a New Surgical Robot Micro Hand S Versus da Vinci, Can be Attained Simultaneously: a Single Center Experience

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Device: Micro Hand S robot and da Vinci robot; Device: da Vinci robot

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Micro Hand S robot and da Vinci robot; The surgeries are performed with the Micro Hand S robot and da Vinci robot
Active Comparator: 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	Device: da Vinci robot; The surgeries are performed with the da Vinci robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of surgical procedure	It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection	up to 1 week after operation
Operative time (min)	It was defined as the duration from skin incision to skin closure	up to 1 week after operation
Console time (min)	The console time was defined the fime that the surgeon performed the surgeon console.	up to 1 week after operation
Docking time (min)	The docking time was the time from moving robotic instruments in the surgical field to setting robotic arms into the port sites	up to 1 week after operation
Conversion	Conversion was defined as any change in strategy to open surgery	up to 1 week after operation
Bloos loss (ml)	It was defined as the amount of blood in the whole surgical time	up to 1 week after operation
Hospital stay (day)	It was defined as the length of hospital stay	up to 1 month after operation
Protective ileostomy	It was defined as ileostomy which diverted the feces to to ensure anastomotic healing	up to 1 month after operation
Retrieved lymph node	It was defined as the number of all the lymph nodes for each patient	up to 1 month after operation
Surgical failure	Surgical failure was defined as the presence of one or more of the following four parameters: conversion, the positive surgical margins, severe postoperative complications, the number of harvested lymph nodes less than 12	up to 1 month after operation
pTNM stage	It was defined as the pathological stage of the tumor according the TNM classification	up to 1 month after operation
Tumor size (cm)	It was defined as the longitudinal diameter of the tumor	up to 1 month after operation
Length of distal ressction margin (cm)	It was defined as the distance betwen the distal resection margin and the low margin of the tumor	up to 1 month after operation
Status of the surgical margin	It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope	up to 1 month after operation
Quality of specimen	The quality of the speciman was graded according to the protocol proposed by Quirke	up to 1 month after operation
Postoperative complication	It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification	up to 1 month after operation
Local recurrence	It was defined as the tumor was again found in the pelvic cavity	at least 1 years after operation
Disease free survival	It was defined as the duration between the operation and date of the tumor recurrence	at least 1 years after operation

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: April 18, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: XY3-DSRCS1507A04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No