Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Micro Hand S robot and da Vinci robot
da Vinci robot
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
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
Sites / Locations
- The Third Xiangya Hospital of Central South University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surgeon A
Surgeon B
Arm 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
This group is consisted of 56 cases performed using the da Vinci robot by one single surgeon in low anterior resection for rectal cancer
Outcomes
Primary Outcome Measures
learning curve of console time
It was defined the cumulative sum plot of the consloe time in the chronological order.
learning curve of docking time
It was defined the cumulative sum plot of the docking time in the chronological order.
learning curve of surgicla failure
It was defined the cumulative sum plot of the docking time in the chronological order.
Secondary Outcome Measures
Type of surgical procedure
It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
Operative time (min)
It was defined as the duration from skin incision to skin closure
Console time (min)
The console time was defined the fime that the surgeon performed the surgeon console.
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
Conversion
Conversion was defined as any change in strategy to open surgery
Bloos loss (ml)
It was defined as the amount of blood in the whole surgical time
Hospital stay (day)
It was defined as the length of hospital stay
Protective ileostomy
It was defined as ileostomy which diverted the feces to to ensure anastomotic healing
Retrieved lymph node
It was defined as the number of all the lymph nodes for each patient
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
pTNM stage
It was defined as the pathological stage of the tumor according the TNM classification
Tumor size (cm)
It was defined as the longitudinal diameter of the tumor
Length of distal ressction margin (cm)
It was defined as the distance betwen the distal resection margin and the low margin of the tumor
Status of the surgical margin
It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope
Quality of specimen
The quality of the speciman was graded according to the protocol proposed by Quirke
Postoperative complication
It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification
Local recurrence
It was defined as the tumor was again found in the pelvic cavity
Disease free survival
It was defined as the duration between the operation and date of the tumor recurrence
Full Information
NCT ID
NCT04855448
First Posted
April 18, 2021
Last Updated
April 18, 2021
Sponsor
The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04855448
Brief Title
Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgeon A
Arm Type
Experimental
Arm 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
Arm Title
Surgeon B
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Micro Hand S robot and da Vinci robot
Intervention Description
The surgeries are performed with the Micro Hand S robot and da Vinci robot
Intervention Type
Device
Intervention Name(s)
da Vinci robot
Intervention Description
The surgeries are performed with the da Vinci robot
Primary Outcome Measure Information:
Title
learning curve of console time
Description
It was defined the cumulative sum plot of the consloe time in the chronological order.
Time Frame
up to 1 week after operation
Title
learning curve of docking time
Description
It was defined the cumulative sum plot of the docking time in the chronological order.
Time Frame
up to 1 week after operation
Title
learning curve of surgicla failure
Description
It was defined the cumulative sum plot of the docking time in the chronological order.
Time Frame
up to 1 week after operation
Secondary Outcome Measure Information:
Title
Type of surgical procedure
Description
It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
Time Frame
up to 1 week after operation
Title
Operative time (min)
Description
It was defined as the duration from skin incision to skin closure
Time Frame
up to 1 week after operation
Title
Console time (min)
Description
The console time was defined the fime that the surgeon performed the surgeon console.
Time Frame
up to 1 week after operation
Title
Docking time (min)
Description
The docking time was the time from moving robotic instruments in the surgical field to setting robotic arms into the port sites
Time Frame
up to 1 week after operation
Title
Conversion
Description
Conversion was defined as any change in strategy to open surgery
Time Frame
up to 1 week after operation
Title
Bloos loss (ml)
Description
It was defined as the amount of blood in the whole surgical time
Time Frame
up to 1 week after operation
Title
Hospital stay (day)
Description
It was defined as the length of hospital stay
Time Frame
up to 1 month after operation
Title
Protective ileostomy
Description
It was defined as ileostomy which diverted the feces to to ensure anastomotic healing
Time Frame
up to 1 month after operation
Title
Retrieved lymph node
Description
It was defined as the number of all the lymph nodes for each patient
Time Frame
up to 1 month after operation
Title
Surgical failure
Description
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
Time Frame
up to 1 month after operation
Title
pTNM stage
Description
It was defined as the pathological stage of the tumor according the TNM classification
Time Frame
up to 1 month after operation
Title
Tumor size (cm)
Description
It was defined as the longitudinal diameter of the tumor
Time Frame
up to 1 month after operation
Title
Length of distal ressction margin (cm)
Description
It was defined as the distance betwen the distal resection margin and the low margin of the tumor
Time Frame
up to 1 month after operation
Title
Status of the surgical margin
Description
It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope
Time Frame
up to 1 month after operation
Title
Quality of specimen
Description
The quality of the speciman was graded according to the protocol proposed by Quirke
Time Frame
up to 1 month after operation
Title
Postoperative complication
Description
It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification
Time Frame
up to 1 month after operation
Title
Local recurrence
Description
It was defined as the tumor was again found in the pelvic cavity
Time Frame
at least 1 years after operation
Title
Disease free survival
Description
It was defined as the duration between the operation and date of the tumor recurrence
Time Frame
at least 1 years after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots
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