Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

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, compared with minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy for rectal cancer are unclear. Therefore, the investigators conduct this retrospective study to focus on this concern.

Official Title
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Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot Micro Hand S, Laparoscope

Conditions
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Rectal Cancer

Intervention / Treatment
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* Device: Micro Hand S robot
* Device: Laparoscope


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: Micro Hand S robot-assisted surgery<br>This group is consisted of 40 cases performed using the Micro Hand S robot by one single surgeon for rectal cancer | Device: Micro Hand S robot<br>* The surgeries are performed with the Micro Hand S robot<br>|
| Active Comparator: Laparoscopic surgery<br>This group is consisted of 65 cases performed using the laparoscope by one single surgeon for rectal cancer | Device: Laparoscope<br>* The surgeries are performed with the laparoscope<br>|

What is the study measuring?
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Primary 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 | 
| 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 | 
| Protective ileostomy | It was defined as ileostomy which diverted the feces to To ensure anastomotic healing | up to 1 month after operation | 
| Hospital stay (day) | It was defined as the length of hospital stay | 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 | 
| Retrieved lymph node | It was defined as the number of all the lymph nodes for each patien | 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 | 
| 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 | 
| International Prostate Symptom Score | It assessed the urination with 7 items | at least12 months after operation | 
| International Index of Erectile Function | It assessed erectile function with 5 items | at least 12 months 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 |