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A Prospective Randomized Comparison of Pure Laparoscopic and Laparoendoscopic Single-site Plus One Trocar Donor Nephrectomy.

Status Approved

First Submitted Date

2017/03/02
Registered Date

2017/05/23
Last Updated Date

2017/04/06

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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	KCT0002336
Unique Protocol ID	KC15EISI0015
Public/Brief Title	A Prospective Randomized Comparison of two techniques for minimally invasive surgery in donor nephrectomy
Scientific Title	A Prospective Randomized Comparison of Pure Laparoscopic and Laparoendoscopic Single-site Plus One Trocar Donor Nephrectomy.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC15EISI0015
Approval Date	2015-02-26
Institutional Review Board Name	Seoul St.Mary`s hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
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	Hyuk Jin Cho
Title	assistant professor
Telephone	+82-2-2258-1401
Affiliation	The Catholic University of Korea
Address	Seoul St Mary’s hospital, 222, Banpo-daero, Seocho-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Hyuk Jin Cho
Title	assistant professor
Telephone	+82-2-2258-1401
Affiliation	The Catholic University of Korea
Address	Seoul St Mary’s hospital, 222, Banpo-daero, Seocho-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Hyuk Jin Cho
Title	assistant professor
Telephone	+82-2-2258-1401
Affiliation	The Catholic University of Korea
Address	Seoul St Mary’s hospital, 222, Banpo-daero, Seocho-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	2015-03-25 Actual
Target Number of Participant	52
Primary Completion Date	2017-02-01 , Actual
Study Completion Date	2017-02-10 , Actual
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2015-03-25 ,

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	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute
Project ID	KC15EISI0015

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Kidney transplantation is an effective treatment option for patients with irreversible chronic kidney failure. Studies based on large series have demonstrated that graft survival is longer in living donor transplantation than deceased donor transplantation. However, concerns about perioperative morbidities and long-term complications, which can negatively impact quality of life (QoL), may prevent people from becoming kidney donors. Since its introduction in 1995, the laparoscopic approach has become an established method for living donor nephrectomy. Recently, efforts to improve donor QoL have led to the development of more minimally invasive donor nephrectomy techniques, such as laparoendoscopic single-site surgery donor nephrectomy (LESS-DN). LESS-DN facilitates early recovery and offers improved cosmesis for kidney donors, but is not yet a standard technique for living donor nephrectomy. This is because LESS is technically challenging due to intra/extracorporeal clashing of instruments and limited triangulation and may require specialized instruments. Furthermore, to gain adequate access or counter-traction and to manage intraoperative complications such as uncontrolled bleeding, conversion to conventional laparoscopy or open surgery is often necessary during LESS surgery. One additional port placement at the beginning of the procedure can help overcome the limitations of LESS-DN. In a previous retrospective study, we concluded that laparoendoscopic single-site plus one-port donor nephrectomy (LESSOP-DN) is a good alternative to LESS-DN. Another technique that can reduce perioperative morbidity and improve cosmetic outcome is the mini-LDN (MLDN) technique, which is a modification of standard LDN. A Pfannenstiel incision is made as the extraction site of the kidney and is utilized as a large instrument insertion site to minimize the size of the other trocars. In the present study, we report the results of a randomized prospective comparison of LESSOP-DN and MLDN.

Study Summary Information

Lay Summary

Kidney transplantation is an effective treatment option for patients with irreversible chronic kidney failure. Studies based on large series have demonstrated that graft survival is longer in living donor transplantation than deceased donor transplantation. However, concerns about perioperative morbidities and long-term complications, which can negatively impact quality of life (QoL), may prevent people from becoming kidney donors.
Since its introduction in 1995, the laparoscopic approach has become an established method for living donor nephrectomy. Recently, efforts to improve donor QoL have led to the development of more minimally invasive donor nephrectomy techniques, such as laparoendoscopic single-site surgery donor nephrectomy (LESS-DN). LESS-DN facilitates early recovery and offers improved cosmesis for kidney donors, but is not yet a standard technique for living donor nephrectomy. This is because LESS is technically challenging due to intra/extracorporeal clashing of instruments and limited triangulation and may require specialized instruments. Furthermore, to gain adequate access or counter-traction and to manage intraoperative complications such as uncontrolled bleeding, conversion to conventional laparoscopy or open surgery is often necessary during LESS surgery.
One additional port placement at the beginning of the procedure can help overcome the limitations of LESS-DN. In a previous retrospective study, we concluded that laparoendoscopic single-site plus one-port donor nephrectomy (LESSOP-DN) is a good alternative to LESS-DN.
Another technique that can reduce perioperative morbidity and improve cosmetic outcome is the mini-LDN (MLDN) technique, which is a modification of standard LDN. A Pfannenstiel incision is made as the extraction site of the kidney and is utilized as a large instrument insertion site to minimize the size of the other trocars.
In the present study, we report the results of a randomized prospective comparison of LESSOP-DN and MLDN.

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	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Patient selection This prospective, randomized trial was approved by Institutional Review Board of Catholic Medical Center. (protocol # KC15EISI0015) All surgeries were performed by a single surgeon (H.J.C.) at a single center. Eligible donors underwent preoperative medical and psychological evaluations and met the usual criteria for kidney donation. Donors who were chosen for right-sided donor nephrectomy determined by renal function (more than 10% difference in function) were excluded. After informed consent was obtained, the study coordinator randomized the subject to LESSOP-DN or MLDN according to computer generated list. Surgical technique All procedures in both groups were performed with the patient in a modified flank position for a transperitoneal approach. LESSOP-DN was performed through a single periumbilical incision measuring 3-3.5 cm using a GelPOINTTM (Applied Medical Rancho Santa Margarita, CA) platform, with an additional 12-mm port for the other working channel at the lateral abdominal wall. A 12-mm trocar for the operating instrument and an 11-mm trocar for the camera were placed within the GelPOINTTM. For the MLDN procedure, a Pfannenstiel incision measuring 4-5 cm was made, and a SurgiTractor (SurgiCore Co., Ltd., Ansan, Korea) was placed. Then, one 11-mm umbilical trocar for the camera and two 5-mm trocars for operating instruments were placed. Large instruments such as a right-angle forceps, Endo RetractTM II 10 mm (Covidien, Norwalk, CT, USA), Multifire Endo GIATM stapling device (Covidien, Norwalk, CT, USA), and LapBag (Sejong Medical, Seoul, Korea) could be accessed via the SurgiTractor. Both procedures used the same laparoscopic instruments, including a conventional 10-mm laparoscope; no articulating or specialized laparoscopic instruments were needed. After port insertion, the surgical steps were similar in both groups. Two temporary retraction sutures were used to provide traction of the kidney and the colon to expose the renal hilum.13 Once the hilar structures were ready to be ligated, the renal allograft was placed in a LapBag, and then the string of the LapBag was pulled out through the abdominal wall and grasped by a Carter Thompson needle. By pulling the pre-bagged kidney toward the abdominal wall, the renal hilum was exposed, and the vessels could be easily ligated. After dividing the renal vessels, the kidney was extracted via the periumbilical incision in LESSOP-DN or the Pfannenstiel incision in MLDN. The surgical technique has been described in detail previously.13 Postoperatively, all patients received patient-controlled analgesia (PCA), and rescue analgesia was provided for uncontrolled pain. Patients were usually discharged when they could ambulate, eat an adequate diet, and control their pain by oral analgesia.
Number of Arms	2
Arm 1	Arm Label laparoendoscopic single-site plus one-port donor nephrectomy
	Target Number of Participant 26
	Arm Type Experimental
	Arm Description LESSOP-DN was performed through a single periumbilical incision measuring 3-3.5 cm using a GelPOINTTM (Applied Medical Rancho Santa Margarita, CA) platform, with an additional 12-mm port for the other working channel at the lateral abdominal wall. A 12-mm trocar for the operating instrument and an 11-mm trocar for the camera were placed within the GelPOINTTM.
Arm 2	Arm Label mini laparoscopic donor nephrectomy
	Target Number of Participant 26
	Arm Type Active comparator
	Arm Description A Pfannenstiel incision measuring 4-5 cm was made, and a SurgiTractor (SurgiCore Co., Ltd., Ansan, Korea) was placed. Then, one 11-mm umbilical trocar for the camera and two 5-mm trocars for operating instruments were placed. Large instruments such as a right-angle forceps, Endo RetractTM II 10 mm (Covidien, Norwalk, CT, USA), Multifire Endo GIATM stapling device (Covidien, Norwalk, CT, USA), and LapBag (Sejong Medical, Seoul, Korea) could be accessed via the SurgiTractor.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (Z00-Z99)Factors influencing health status and contact with health services (Z52.6)Liver donor
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description Eligible donors underwent preoperative medical and psychological evaluations and met the usual criteria for kidney donation.
Exclusion Criteria	previous operation history right-sided donor nephrectomy co-operation (ex: cholecystectomy)
Healthy Volunteers	Yes

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	Efficacy
Outcome	cosmetic outcome
Timepoint	postoperative 1 month, 6 month
Secondary Outcome(s) 1
Outcome	operative time
Timepoint	perioperative
Secondary Outcome(s) 2
Outcome	estimated blood loss
Timepoint	perioperative
Secondary Outcome(s) 3
Outcome	warm ischemic time
Timepoint	perioperative
Secondary Outcome(s) 4
Outcome	transfusion
Timepoint	perioperative
Secondary Outcome(s) 5
Outcome	conversion rate
Timepoint	perioperative

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

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

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