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Solo-Surgeon Pure Laparoscopic Living Donor Nephrectomy Using Camera Holder: A Pilot Study

Status Approved

First Submitted Date

2018/10/24
Registered Date

2019/01/30
Last Updated Date

2020/02/03

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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	KCT0003458
Unique Protocol ID	2018-0864
Public/Brief Title	Solo-Surgeon Pure Laparoscopic Living Donor Nephrectomy Using Camera Holder: A Pilot Study
Scientific Title	Solo-Surgeon Pure Laparoscopic Living Donor Nephrectomy Using Camera Holder: A Pilot Study
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	2018-0864
Approval Date	2018-07-23
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

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	Dalsan You
Title	Associste Professor
Telephone	+82-2-3010-3979
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Dong Hyeon An
Title	Resident
Telephone	+82-2-3010-0257
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Dong Hyeon An
Title	Resident
Telephone	+82-2-3010-0257
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of 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	Completed
Date of First Enrollment	2018-11-05 Actual
Target Number of Participant	40
Primary Completion Date	2019-11-26 , Actual
Study Completion Date	2019-12-31 , Actual
Name of Study	Asan Medical Center
Recruitment Status	Completed
Date of First Enrollment	2018-11-05 ,

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	Asan Medical Center
Organization Type	Medical Institute
Project ID	2018-0864

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The purpose of this study is to determine feasibility and safety of pure laparoscopic donor nephrectomy using a camera holder. For stable surgery during laparoscopic surgery the assistant who holds the camera should keep the image stable, pose the surgical site in the center of the monitor, and provide an unrotated image. However, since the assistant who holds the camera is mostly a resident, it is difficult to accumulate experience by maintaining a stable technique continuously. Even experienced assistants suffer from the difficulty of maintaining stable images because fatigue accumulates. Through the use of a camera holder, a surgeon alone can perform surgery without the aid of an assistant during laparoscopic surgery, which is called a solo-surgery. Solo-surgery is divided into complete solo-surgery which is performed alone from the skin incision to wound closure and partial solo-surgery which only laparoscopic operation is performed alone. In addition to the advantages mentioned above, the solo-surgery also has the advantage of reducing labor costs. However, because the surgeon should adjust the camera position, the operation time may become longer. And it may take time until a medical team arrives to help when an unexpected emergency occurs. In addition, fixed cameras may interfere with surgery and have the disadvantage of losing the opportunity to provide appropriate training for residents. Therefore, it is necessary to demonstrate the feasibility and safety of pure laparoscopic donor nephrectomy performed performed by the surgeon alone.

Study Summary Information

Lay Summary

The purpose of this study is to determine feasibility and safety of pure laparoscopic donor nephrectomy using a camera holder.
For stable surgery during laparoscopic surgery the assistant who holds the camera should keep the image stable, pose the surgical site in the center of the monitor, and provide an unrotated image. However, since the assistant who holds the camera is mostly a resident, it is difficult to accumulate experience by maintaining a stable technique continuously. Even experienced assistants suffer from the difficulty of maintaining stable images because fatigue accumulates.
Through the use of a camera holder, a surgeon alone can perform surgery without the aid of an assistant during laparoscopic surgery, which is called a solo-surgery. Solo-surgery is divided into complete solo-surgery which is performed alone from the skin incision to wound closure and partial solo-surgery which only laparoscopic operation is performed alone.
In addition to the advantages mentioned above, the solo-surgery also has the advantage of reducing labor costs. However, because the surgeon should adjust the camera position, the operation time may become longer. And it may take time until a medical team arrives to help when an unexpected emergency occurs. In addition, fixed cameras may interfere with surgery and have the disadvantage of losing the opportunity to provide appropriate training for residents.
Therefore, it is necessary to demonstrate the feasibility and safety of pure laparoscopic donor nephrectomy performed performed by the surgeon alone.

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	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	/Procedure/Surgery
Intervention Description	The camera assistant is replaced as the camera holder (Passive camera holder, FISSO). This is confined from the time of laparoscopic port placement until the time of hemostasis. The skin incision to port placement and wound closure are performed together with the assistant.
Number of Arms	1
Arm 1	Arm Label Solo-surgeon pure laparoscopic living donor nephrectomy
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description The camera assistant is replaced as the camera holder (Passive camera holder, FISSO). This is confined from the time of laparoscopic port placement until the time of hemostasis. The skin incision to port placement and wound closure are performed together with the assistant.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Medical equipment Kidney; Transplant Donor Site
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 10Year~79Year
	Description Living kidney donors aged ≥18 and <80 years who can speak in Korean language
Exclusion Criteria	Donors unable to undergo pure laparoscopic donor nephrectomy due to previous abdominal surgery Donors to be unwilling to participate in the study Donors to be inappropriate to participate in the study according to the investigator
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
Outcome	Feasibility, Intraoperative complication, Postoperative complication
Timepoint	During surgery, During surgery, Until postoperative 90 days
Secondary Outcome(s) 1
Outcome	Operative parameters, Convalescence parameters, Early graft outcomes
Timepoint	During surgery, Until discharge, Until postoperative 7 days

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	Yes
Time of Sharing	2020. 3
Way of Sharing	Available on Request (dalsanyou@amc.seoul.kr)

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