Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots

Rectal Cancer Clinical Trial

Official title:

Accelerated Learning Curve in Low Anterior Resection for Rectal Resection, a New Surgical Robot Micro Hand S Versus da Vinci, Can be Attained Simultaneously: a Single Center Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04855448
• Other study ID #: XY3-DSRCS1507A04
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

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