Domestic Surgical Robot Clinical Study

Not Applicable

• Conditions: Rectal Cancer; Cholecystolithiasis; Appendicitis; Gastric Bypass; Gastric Ulcer With Perforation But Without Obstruction; Colon Cancer; Sleeve Gastrectomy; Gastric Cancer
• Interventions: Procedure: Micro Hand S robotic surgery; Procedure: laparoscopic surgery; Procedure: da Vinci robotic surgery

• Registration Number: NCT02752698
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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. 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

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.

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micro Hand S robotic group	Micro Hand S robotic surgery	Micro Hand S robotic surgery group
laparoscopic surgery	laparoscopic surgery	laparoscopic surgery group
da Vinci robotic group	da Vinci robotic surgery	da Vinci robotic robotic group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China