임상연구정보서비스

Search: Search

Single-port (SP) Versus Multiport Robotic Rectal Resection for Rectal Cancer: Randomised Clinical Trial

Status Approved

First Submitted Date

2021/03/14
Registered Date

2021/03/16
Last Updated Date

2021/03/14

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006007
Unique Protocol ID	KNUCH2020-10-014-001
Public/Brief Title	Single-port (SP) Versus Multiport Robotic Rectal Resection
Scientific Title	Single-port (SP) Versus Multiport Robotic Rectal Resection for Rectal Cancer: Randomised Clinical Trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KNUCH2020-10-014-001
Approval Date	2020-12-04
Institutional Review Board Name	Institutional Review Board, Kyungpook National University Chilgok Hospital
Institutional Review Board Address	807, Hoguk-ro, Buk-gu, Daegu
Institutional Review Board Telephone	053-200-2162
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Gyu-Seog Choi
Title	Dr
Telephone	+82-53-200-2166
Affiliation	Kyungpook National University Medical Center
Address	807, Hoguk-ro, Buk-gu, Daegu 41404, KOREA
Contact Person for Public Queries
Name	Hye Jin Kim
Title	Dr
Telephone	+82-53-200-2166
Affiliation	Kyungpook National University Medical Center
Address	807, Hoguk-ro, Buk-gu, Daegu 41404, KOREA
Contact Person for Updating Information
Name	Seung Ho Song
Title	Dr
Telephone	+82-53-200-2166
Affiliation	Kyungpook National University Medical Center
Address	807, Hoguk-ro, Buk-gu, Daegu 41404, KOREA

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-03-14 Anticipated
Target Number of Participant	80
Primary Completion Date	2022-03-14 , Anticipated
Study Completion Date	2024-07-14 , Anticipated
Name of Study	Kyungpook National University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2021-03-14 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kyungpook National University Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyungpook National University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Minimally invasive surgery is currently accepted as the standard treatment for rectal surgery. Fast recovery after surgery, less pain, shorter hospital stay, and less blood loss are known advantages of minimally invasive surgery. In 2008, single-port laparoscopic surgery was introduced. However, single-port surgery requires difficult skills, and several clinical studies have not yet revealed clear benefits. Nonetheless, there are some studies showing that there are cosmetic benefits, pain relief, and quick recovery in single-port surgery. The research team has already performed more than 20 single-port robotic surgery since July 2020, and clinically confirmed that there are no significant complications. Based on the experience of laparoscopy and robotic surgery over the past 20 years, we want to confirm the clinical effectiveness of the new device (single-port robot) by comparing the clinical results with the multiport robotic surgery for rectal cancer.

Study Summary Information

Lay Summary

Minimally invasive surgery is currently accepted as the standard treatment for rectal surgery.
Fast recovery after surgery, less pain, shorter hospital stay, and less blood loss are known advantages of minimally invasive surgery.
In 2008, single-port laparoscopic surgery was introduced.
However, single-port surgery requires difficult skills, and several clinical studies have not yet revealed clear benefits.
Nonetheless, there are some studies showing that there are cosmetic benefits, pain relief, and quick recovery in single-port surgery.
The research team has already performed more than 20 single-port robotic surgery since July 2020, and clinically confirmed that there are no significant complications.
Based on the experience of laparoscopy and robotic surgery over the past 20 years, we want to confirm the clinical effectiveness of the new device (single-port robot) by comparing the clinical results with the multiport robotic surgery for rectal cancer.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	For rectal resection in patients with rectal cancer, a single-port robot was used for the experimental group and a multiport robot was used for the control group.
Number of Arms	2
Arm 1	Arm Label single-port robot
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Single-port robotic rectal resection for rectal cancer
Arm 2	Arm Label multiport robot
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description Multiport robotic rectal resection for rectal cancer

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C20)Malignant neoplasm of rectum Rectal Neoplasms
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description 1. Adults 18 years of age or older 2. ECOG (Eastern Cooperative Oncology Group) performance status 0-3 3. Rectal cancer located less than 10cm from the anal verge, confirmed histologically 4. Pathological type: adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma 5. Patients who received preoperative chemoradiation therapy are selected.
Exclusion Criteria	1. Patients with difficulty in anal preservation surgery (cancer invasion to levator ani) 2. Distant metastasis is confirmed by imaging or histology (cTanyNanyM1) 3. Familial Adenomatous polyposis 4. Hereditary non-polyposis colorectal cancer 5. Central nerve system disorders or mental illness, Patients with evidence of central nervous system metastasis 6. Pregnancy or lactating women 7. Unhealed wound, fracture, peptic ulcer, intra-abdominal abscess 8. Active gastrointestinal bleeding 9. Acute infection requiring intravenous antibiotics 10. Emergency operation
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Hospital stay
Timepoint	At discharge
Secondary Outcome(s) 1
Outcome	Intraoperative complication
Timepoint	Operative day
Secondary Outcome(s) 2
Outcome	Operative time
Timepoint	Operative day
Secondary Outcome(s) 3
Outcome	Blood loss during surgery
Timepoint	Operative day
Secondary Outcome(s) 4
Outcome	Wound length
Timepoint	Operative day
Secondary Outcome(s) 5
Outcome	Pain score after surgery
Timepoint	24, 48, 72 hours after surgery
Secondary Outcome(s) 6
Outcome	Harvested lymph nodes
Timepoint	28 days after surgery
Secondary Outcome(s) 7
Outcome	Circumferential resection margin involvement
Timepoint	28 days after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top