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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Device: Micro Hand S robot and da Vinci robot
* Device: da Vinci robot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgeon A<br>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<br>* The surgeries are performed with the Micro Hand S robot and da Vinci robot<br>|
| Active Comparator: Surgeon B<br>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<br>* The surgeries are performed with the da Vinci robot<br>|

What is the study measuring?
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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 |