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Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Micro Hand S robot
Laparoscope
Sponsored by
The Third Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Third Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Micro Hand S robot-assisted surgery

Laparoscopic surgery

Arm Description

This group is consisted of 40 cases performed using the Micro Hand S robot by one single surgeon for rectal cancer

This group is consisted of 65 cases performed using the laparoscope by one single surgeon for rectal cancer

Outcomes

Primary Outcome Measures

Type of surgical procedure
It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
Operative time (min)
It was defined as the duration from skin incision to skin closure
Conversion
Conversion was defined as any change in strategy to open surgery
Bloos loss (ml)
It was defined as the amount of blood in the whole surgical time
Protective ileostomy
It was defined as ileostomy which diverted the feces to To ensure anastomotic healing
Hospital stay (day)
It was defined as the length of hospital stay
Tumor size (cm)
It was defined as the longitudinal diameter of the tumor
Retrieved lymph node
It was defined as the number of all the lymph nodes for each patien
pTNM stage
It was defined as the pathological stage of the tumor according the TNM classification
Length of distal ressction margin (cm)
It was defined as the distance betwen the distal resection margin and the low margin of the tumor
Status of the surgical margin
It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope
Quality of specimen
The quality of the speciman was graded according to the protocol proposed by Quirke
Postoperative complication
It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification
International Prostate Symptom Score
It assessed the urination with 7 items
International Index of Erectile Function
It assessed erectile function with 5 items
Local recurrence
It was defined as the tumor was again found in the pelvic cavity
Disease free survival
It was defined as the duration between the operation and date of the tumor recurrence

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
April 5, 2021
Sponsor
The Third Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04836741
Brief Title
Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer
Official Title
Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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, compared with minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy for rectal cancer are unclear. Therefore, the investigators conduct this retrospective study to focus on this concern.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micro Hand S robot-assisted surgery
Arm Type
Experimental
Arm Description
This group is consisted of 40 cases performed using the Micro Hand S robot by one single surgeon for rectal cancer
Arm Title
Laparoscopic surgery
Arm Type
Active Comparator
Arm Description
This group is consisted of 65 cases performed using the laparoscope by one single surgeon for rectal cancer
Intervention Type
Device
Intervention Name(s)
Micro Hand S robot
Intervention Description
The surgeries are performed with the Micro Hand S robot
Intervention Type
Device
Intervention Name(s)
Laparoscope
Intervention Description
The surgeries are performed with the laparoscope
Primary Outcome Measure Information:
Title
Type of surgical procedure
Description
It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
Time Frame
up to 1 week after operation
Title
Operative time (min)
Description
It was defined as the duration from skin incision to skin closure
Time Frame
up to 1 week after operation
Title
Conversion
Description
Conversion was defined as any change in strategy to open surgery
Time Frame
up to 1 week after operation
Title
Bloos loss (ml)
Description
It was defined as the amount of blood in the whole surgical time
Time Frame
up to 1 week after operation
Title
Protective ileostomy
Description
It was defined as ileostomy which diverted the feces to To ensure anastomotic healing
Time Frame
up to 1 month after operation
Title
Hospital stay (day)
Description
It was defined as the length of hospital stay
Time Frame
up to 1 month after operation
Title
Tumor size (cm)
Description
It was defined as the longitudinal diameter of the tumor
Time Frame
up to 1 month after operation
Title
Retrieved lymph node
Description
It was defined as the number of all the lymph nodes for each patien
Time Frame
up to 1 month after operation
Title
pTNM stage
Description
It was defined as the pathological stage of the tumor according the TNM classification
Time Frame
up to 1 month after operation
Title
Length of distal ressction margin (cm)
Description
It was defined as the distance betwen the distal resection margin and the low margin of the tumor
Time Frame
up to 1 month after operation
Title
Status of the surgical margin
Description
It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope
Time Frame
up to 1 month after operation
Title
Quality of specimen
Description
The quality of the speciman was graded according to the protocol proposed by Quirke
Time Frame
up to 1 month after operation
Title
Postoperative complication
Description
It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification
Time Frame
up to 1 month after operation
Title
International Prostate Symptom Score
Description
It assessed the urination with 7 items
Time Frame
at least12 months after operation
Title
International Index of Erectile Function
Description
It assessed erectile function with 5 items
Time Frame
at least 12 months after operation
Title
Local recurrence
Description
It was defined as the tumor was again found in the pelvic cavity
Time Frame
at least 1 years after operation
Title
Disease free survival
Description
It was defined as the duration between the operation and date of the tumor recurrence
Time Frame
at least 1 years after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34098897
Citation
Wang Y, Wang G, Li Z, Ling H, Yi B, Zhu S. Comparison of the operative outcomes and learning curves between laparoscopic and "Micro Hand S" robot-assisted total mesorectal excision for rectal cancer: a retrospective study. BMC Gastroenterol. 2021 Jun 7;21(1):251. doi: 10.1186/s12876-021-01834-1.
Results Reference
derived

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Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

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