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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04855448
Other study ID # XY3-DSRCS1507A04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date October 31, 2019

Study information

Verified date April 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

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. 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. The Micro Hand S robot is safe and feasible in the preliminary study. However, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.


Description:

The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The safey and feasibility has been evaluated. However, the learning curve of this procedure is unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously are unclear.Therefore, this srudy is conducted to evaluate the learning curve of the two robots in low anterior resection.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date October 31, 2019
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - histologically confirmed rectal cancer; ASA score = 3 Exclusion Criteria: - palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Micro Hand S robot and da Vinci robot
The surgeries are performed with the Micro Hand S robot and da Vinci robot
da Vinci robot
The surgeries are performed with the da Vinci robot

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary learning curve of console time It was defined the cumulative sum plot of the consloe time in the chronological order. up to 1 week after operation
Primary learning curve of docking time It was defined the cumulative sum plot of the docking time in the chronological order. up to 1 week after operation
Primary learning curve of surgicla failure It was defined the cumulative sum plot of the docking time in the chronological order. up to 1 week after operation
Secondary Type of surgical procedure It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection up to 1 week after operation
Secondary Operative time (min) It was defined as the duration from skin incision to skin closure up to 1 week after operation
Secondary Console time (min) The console time was defined the fime that the surgeon performed the surgeon console. up to 1 week after operation
Secondary Docking time (min) The docking time was the time from moving robotic instruments in the surgical field to setting robotic arms into the port sites up to 1 week after operation
Secondary Conversion Conversion was defined as any change in strategy to open surgery up to 1 week after operation
Secondary Bloos loss (ml) It was defined as the amount of blood in the whole surgical time up to 1 week after operation
Secondary Hospital stay (day) It was defined as the length of hospital stay up to 1 month after operation
Secondary Protective ileostomy It was defined as ileostomy which diverted the feces to to ensure anastomotic healing up to 1 month after operation
Secondary Retrieved lymph node It was defined as the number of all the lymph nodes for each patient up to 1 month after operation
Secondary Surgical failure Surgical failure was defined as the presence of one or more of the following four parameters: conversion, the positive surgical margins, severe postoperative complications, the number of harvested lymph nodes less than 12 up to 1 month after operation
Secondary pTNM stage It was defined as the pathological stage of the tumor according the TNM classification up to 1 month after operation
Secondary Tumor size (cm) It was defined as the longitudinal diameter of the tumor up to 1 month after operation
Secondary Length of distal ressction margin (cm) It was defined as the distance betwen the distal resection margin and the low margin of the tumor up to 1 month after operation
Secondary Status of the surgical margin It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope up to 1 month after operation
Secondary Quality of specimen The quality of the speciman was graded according to the protocol proposed by Quirke up to 1 month after operation
Secondary Postoperative complication It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification up to 1 month after operation
Secondary Local recurrence It was defined as the tumor was again found in the pelvic cavity at least 1 years after operation
Secondary Disease free survival It was defined as the duration between the operation and date of the tumor recurrence at least 1 years after operation
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