Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04122261
Other study ID # SDWG-NST600S-CT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2019
Est. completion date October 1, 2021

Study information

Verified date October 2021
Source The Third Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multi-center, randomized, single-blind, parallel-controlled clinical trial to evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.


Description:

To evaluate the safety and efficacy of the Chinese domestic endoscopic instrument control system in clinical treatment.This clinical trial is a prospective, multi-center, randomized, single-blind, parallel-controlled study. The system used in the experimental group is the endoscopic instrument control system developed by WEGO Surgical Robot Co., Ltd., and the system used in the control group is the da Vinci endoscopic instrument control system developed by Intuitive Surgical. Before patients are enrolled in this clinical study, the researchers will do a detailed screening of the subjects based on the inclusion criteria and the exclusion criteria to determine if the patients are appropriate for the clinical study. Patients who meet the conditions of the study will be required to sign an informed consent form. Then they will be randomly assigned to the experimental group or the control group. To evaluate the primary outcome measures and secondary outcome measures and to observe the incidence of organ and vascular injury. Finally, we evaluate the safety and efficacy of the test product through the comparison of the data obtained from the experimental group and the control group during the treatment.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Device:
the MicroHand S endoscopic instrument control system
Using the MicroHand S endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.
the da Vinci endoscopic instrument control system
Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in minimal invasive surgery.

Locations

Country Name City State
China The Third Xiangya Hospital of Central South University Changsha Hunan

Sponsors (2)

Lead Sponsor Collaborator
The Third Xiangya Hospital of Central South University The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary surgical success rate The surgical success rate is defined as the proportion of successfully operative subjects in the experimental group or the control group. within 24 hours after operation
Secondary The breakage rate of gallbladder The breakage rate of gallbladder is defined as the proportion of the subjects in the experimental group or the control group with specimen breakage. within 12 hours after operation
Secondary Comprehensive Complication Index (CCI) CCI is calculated using online tools provided by http://cci.assessurgery.com. Based on the Clavien-Dindo complications grade system (appendix.1), all complications and adverse events after surgical intervention are taken into consideration. The overall incidence is measured on a scale ranging from 0 (no complication) to 100 (death). an average of 5 days after operation
Secondary Operative time The length of time from the beginning of the operation after the robot installation to the end of the suture of the incision. within 12 hours after operation
Secondary Intraoperative bleeding The total bleeding volume from the beginning of the operation to the end of the suture of the incision. It can be calculated by measuring the blood volume in the vacuum suction device and weighing the gauze after using them to wipe the bleeding. within 12 hours after operation
Secondary Postoperative pain Postoperative pain is assessed by visual analogue scale (VAS) 24-26 hours after the operation, ranging from 0 (no pain) to 10 (maximum pain). within 24 hours after operation
Secondary Time to first flatus The time from the end of the operation to the subject's first flatus after surgery. an average of 2 days after operation
Secondary Surgeon's satisfaction After the operation, surgeons fill a questionnaire to score the flexibility, intuition and stability of the products, as well as their sense of delay and fatigue when using the products. Each question in the score ranges from 1 to 5 points and the total score is 100. within 12 hours after operation
Secondary Installation time The time from the power-on of the products to the end of the connection between trocars and the operative arms. preoperation
Secondary Hospital stay The total hospital days of subjects from admission to discharge. an average of 5 days after operation
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03636841 - Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis N/A
Completed NCT02379780 - Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy N/A
Completed NCT01937104 - ONSD According to the Position During Laparoscopy N/A
Completed NCT02461147 - Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Completed NCT02264444 - Establishing Visualization Grading Scale on LESS Cholecystectomy N/A
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT00940264 - Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. N/A
Completed NCT00746850 - Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis N/A
Completed NCT00370344 - Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Phase 2/Phase 3
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT02858986 - 3D Versus 4K Laparoscopic Cholecystectomy N/A
Completed NCT04602156 - US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy N/A
Completed NCT04942665 - Low Dose ICG for Biliary Tract and Tumor Imaging Phase 2
Completed NCT02547064 - Effect of Modified Stylet Angulation on the Intubation With GlideScope® N/A
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Completed NCT04716166 - Incentive Spirometry and Upper Abdominal Laparoscopic Surgery N/A
Completed NCT01476319 - Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department N/A
Withdrawn NCT02225418 - Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy N/A
Suspended NCT04306939 - Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
Completed NCT02782832 - No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery