Domestic Surgical Robot Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-12-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Micro Hand S robotic group

Micro Hand S robotic surgery group

Group Type EXPERIMENTAL

Micro Hand S robotic surgery

Intervention Type PROCEDURE

20-70 patients undergo Micro Hand S robotic surgeries

laparoscopic surgery

laparoscopic surgery group

Group Type OTHER

laparoscopic surgery

Intervention Type PROCEDURE

20-70 patients undergo laparoscopic surgeries

da Vinci robotic group

da Vinci robotic robotic group

Group Type OTHER

da Vinci robotic surgery

Intervention Type PROCEDURE

20-70 patients undergo da Vinci robotic surgeries

Interventions

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Micro Hand S robotic surgery

20-70 patients undergo Micro Hand S robotic surgeries

Intervention Type PROCEDURE

laparoscopic surgery

20-70 patients undergo laparoscopic surgeries

Intervention Type PROCEDURE

da Vinci robotic surgery

20-70 patients undergo da Vinci robotic surgeries

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No