Domestic Surgical Robot Clinical Study

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. Recently, as the domestic surgical robot research project's main section, 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.

Detailed Description
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One surgeon perform these surgical trials using the robot Micro Hand S. All of the patients were followed for 12 months, and pre- and postoperative changes in blood route test and hepatorenal function examination, surgery duration, hospital stay, total robotic setup time, total robotic operation time, intraoperative blood loss, total postoperative drainage amount, duration of bearing drainage tubes were recorded. In addition, the pre- and postoperative changes in the pathological and functional outcomes were measured.

Official Title
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Safety and Feasible Study of Domestic Surgical Robot That Had Been Authorized to Enter the Clinical Trial Stage

Conditions
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Gastric Ulcer With Perforation But Without Obstruction, Colon Cancer, Cholecystolithiasis, Appendicitis, Sleeve Gastrectomy, Gastric Bypass, Gastric Cancer, Rectal Cancer

Intervention / Treatment
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* Procedure: Micro Hand S robotic surgery
* Procedure: laparoscopic surgery
* Procedure: da Vinci robotic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively 18years<age<65years male or female Exclusion Criteria: patients with a history of open abdominal surgery unstable psychiatric illness an inability or reluctance to cooperate during long-term follow-up alcohol or drug addiction or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study

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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micro Hand S robotic group<br>Micro Hand S robotic surgery group | Procedure: Micro Hand S robotic surgery<br>* 20-70 patients undergo Micro Hand S robotic surgeries<br>|
| Other: laparoscopic surgery<br>laparoscopic surgery group | Procedure: laparoscopic surgery<br>* 20-70 patients undergo laparoscopic surgeries<br>|
| Other: da Vinci robotic group<br>da Vinci robotic robotic group | Procedure: da Vinci robotic surgery<br>* 20-70 patients undergo da Vinci robotic surgeries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative outcomes | surgical procedure/operative time/console time/blood loss/conversion | up to 1 week after operation | 
| postoperative outcomes | Time to first flatus/intake/hospital stay | up to 1 month after operation | 
| pathological outcomes | resection margin/harvested lymph node/mesorectal grade | up to 1 month after operation | 
| complication | type of complication/grade of complication | within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional outcomes | wexner/ipss/iief score | at least12 months after operation | 
| recurrence | local recurrence and metastasis | at least 12 months after operation | 
| survival | disease free survival/overall survival | at least 12 months yesra after operation | 
| change of blood and biochemiacl | wbc/hgb/albumin/cea | within 1 month after operation |