Domestic Surgical Robot Clinical Study

NCT02752698 | Unknown DMC

• 1 other identifier: XY3-DSRCS1507A01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• functional outcomes

  at least12 months after operation

• recurrence

  at least 12 months after operation

• survival

  at least 12 months yesra after operation

• change of blood and biochemiacl

  within 1 month after operation

Study Arms (3)

Micro Hand S robotic group

EXPERIMENTAL

Micro Hand S robotic surgery group

Procedure: Micro Hand S robotic surgery

laparoscopic surgery

OTHER

laparoscopic surgery group

Procedure: laparoscopic surgery

da Vinci robotic group

OTHER

da Vinci robotic robotic group

Procedure: da Vinci robotic surgery

Interventions

Micro Hand S robotic surgery PROCEDURE

20-70 patients undergo Micro Hand S robotic surgeries

Micro Hand S robotic group

laparoscopic surgery PROCEDURE

20-70 patients undergo laparoscopic surgeries

laparoscopic surgery

da Vinci robotic surgery PROCEDURE

20-70 patients undergo da Vinci robotic surgeries

da Vinci robotic group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively
• years\<age\<65years
• male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (2)

• Lei Y, Jiang J, Zhu S, Yi B, Li J. Comparison of the short-term efficacy of two types of robotic total mesorectal excision for rectal cancer. Tech Coloproctol. 2022 Jan;26(1):19-28. doi: 10.1007/s10151-021-02546-0. Epub 2021 Nov 30.

  PMID: 34846614 DERIVED

• Zeng Y, Wang G, Li Z, Lin H, Zhu S, Yi B. The Micro Hand S vs. da Vinci Surgical Robot-Assisted Surgery on Total Mesorectal Excision: Short-Term Outcomes Using Propensity Score Matching Analysis. Front Surg. 2021 May 11;8:656270. doi: 10.3389/fsurg.2021.656270. eCollection 2021.

  PMID: 34046424 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Cholecystolithiasis; Appendicitis; Stomach Neoplasms; Rectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Cholelithiasis; Biliary Tract Diseases; Gallbladder Diseases; Intraabdominal Infections; Infections; Gastroenteritis; Cecal Diseases; Stomach Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• shaihong zhu, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: April 27, 2016
• Study Start: January 1, 2015
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)