Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001237774
Ethics application status
Approved
Date submitted
5/11/2013
Date registered
12/11/2013
Date last updated
31/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evolution of surgery: kidney transplant by using key-hole surgical technique
Scientific title
Surgical technique evolution: Application of laparoscopic technique to clinical human kidney transplant.

The outcome of surgical morbidity and mortality, kidney graft function will be assessed in comparison with historical conventional open kidney transplant cohort
Secondary ID [1] 283519 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic renal failure 290440 0
Clinic human kidney transplant 290443 0
Condition category
Condition code
Surgery 290828 290828 0 0
Surgical techniques
Renal and Urogenital 290831 290831 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to apply the laparoscopic technique (key-hole surgery) to clinical human kidney transplant after successful pre-clinic experiment in the large animal pig model (RA/3/100/1040, UWA). In order to apply this laparoscopic technique safely to the human kidney transplant, The study has also being conducted on human cadaver body to define the ideal ports position. After successful application of laparoscopic technique in some cases of human kidney transplant, the randomised study will be considered in the near future to demonstrate the advantages of this new technique in clinical kidney transplant such as smaller incision, less pain, quicker recovery, shorter hospital stay, better cosmetics and equal graft function in comparison with routine open surgery.

The approval will be obtained from human research committee. Then, the details of surgical procedure for laparoscopic kidney transplant will be provided and explained to the participants. The consent form will be signed as a new procedure. The description of this new procedure is as follows:
Induction and general anaesthesia. The urethral catheter will be inserted the same as open kidney trasplant surgery.

The patient will be positioned on supine with one side elevated position. The prep and drape are as routine surgical procedure.

The small port incision (about 2 cm) will be made at lower abdomen. The balloon dilator (PDB 10mm, Auto suture) will be inserted into the port site, the peritoneum will be pushed medially by inflating the balloon under laparoscopic vision. Then, the balloon dilator will be replaced by a camera port (BTT 10 mm, Auto Suture). Two/three more ports in the lower abdomen will be inserted under vision for preparation of the pelvic vessels for kidney implantation.

A small superapubic incision (about 7 cm) is made to the extra-peritoneum space for delivery the kidney graft into the iliac fossa. Then this incision is sealed with wet pack or hand-port for preventing gas leakage durng laparoscopic surgery.

The vascular clamp will be placed at proximal and distal part of external iliac artery (EIA).

The arteriotomy on EIA will be made at the site for renal artery anastomosis.

The renal artery is anastomosed by end-to-side fashion to the EIA by 6/0 Prolene suture.

The vascular clamp will be then placed at proximal and distal part of external iliac vein (EIV). The venotomy on EIV will be made at the site for renal vein anastomosis.

The renal vein is anastomosed by end-to-side fashion to the EIV by 5/0 Prolene suture.

The kidney graft will be reperfused by releasing venous clamp first, then arterial clamp following hemostasis check at anastomotic sites.

Hemostasis checked again after kidney graft reperfused.

The ureter is then anastomosed to the bladder by 5/0 PDS suture.

The hemostasis will be checked again, the wound will be washed with warm normal saline. The proper position of the kidney graft will be checked.

The surgical drain will be placed at peri-graft area.

The laparoscopic surgery is completed and the incision and port sites will be closed in layer. The kidney graft is located at iliac fossa which is the same as current open surgery for kidney transplant.

For the safety of the patient as a new major procedure, the study patients will be kept under the nursing special observation for about 48 hours after the kidney transplant before changing to routine ward care. (Usually, the patient was placed in the general ward G63 after open kidney transplant.)
Immediate post-operative care
The patient will be transferred to main recovery room after completion of surgery where immediate post-operative recovery will be closely monitored. The nursing staff in recovery room will be educated for this new procedure prior to commence of study
Follow the protocol in recovery room for immediate post-operative observation
The vital signs will be recorded on the provided chart every 15 minutes
The urine output will be recorded every 30 minutes
The would drainage will be observed closely
Analgesia as per protocol in recovery room
Care on transplant ward.
The patient will be transferred to transplant ward G 63 following satisfactory recovery from immediate post-operative period in recovery room. The patient will be kept under the nursing special observation for about 48 hours after the kidney transplant, then changing to routine care. At any time, if any concerns arise, the care nurse will contact the surgeon immediately. The surgeon will be available 24 hours every day.
Special observation for the first 48 hours on the ward
The vital signs will be observed and recorded hourly
The wound drainage will be closed monitored. The surgeon will be notified at any time if there
is any fresh blood draining.
The urine output will be recorded hourly
The patients can commence clear fluids in the first 24 hours then light diet on day 2 as the
patient can tolerate.
The patient will be examined twice a day by doctor during the period of close observation.
The daily blood test including full blood count (FBC), electrolytes, urea and creatinine level
(EUC) will be performed as the same as to the routine practice after kidney transplant.
The Doppler US of kidney graft will be performed to confirm the adequate perfusion of graft
The nuclear scan of kidney graft will be done as routine to open kidney transplant to examine
the kidney graft perfusion
The patients will be changing to routine ward care after 48 hours of close observation.
The physiotherapy will be involved for routine post-operative recovery.
The renal team will attend the ward round for medical care such as administration of
immunosuppressive agents as the same as post-operative management after open kidney transplant
surgery.
The other associated care will be also provided subject to individual patient needs.
Subcutaneous injection of Heparin 5000 IU twice daily for prophylaxis of DVT/PE.
Routine ward care
The patient will be changing to routine ward care after satisfactory special observation during
first 48 hours.
The vital signs will be observed and recorded twice a day
The patient will be examined once a day by doctor during the ward round.
The daily blood test including full blood count (FBC), electrolytes, urea and creatinine level
(EUC) will be performed as the same as to the routine practice after kidney transplant.
The physiotherapy will be involved for routine post-operative recovery.
The renal team will attend the ward round for medical care in terms of administration of
immunosuppressive agents as the same as post-operative management after open kidney transplant
surgery.
The other associated care will be also provided subject to individual patient needs.
Subcutaneous injection of Heparin 5000 IU bid for prophylaxis of DVT/PE.
The drain tube will be removed on ward after 48 hours
The urethral catheter will be removed between day 5 - day 7 post transplant surgery.
The patient will be considered for discharge after 5-7 days hospitalisation if there are no
surgical and medical concerns with satisfactory recovery of kidney graft function.
Discharge and Follow Up
After discharge, the patient will be followed-up as renal transplant protocol for monitoring kidney graft function and the drug level. During week 1 post transplant, usually the patient is hospitalised for 5-7 days, the daily blood test will be done. During week 2, most of the patients will be discharged and followed up in renal transplant clinic on daily basis with full blood test to monitor kidney graft function and the drug level. During week 3, the patients will be seen in renal transplant clinic 3 times a week and during week 4 the patient will be seen twice a week. From the second to six month the patient will be followed up in transplant clinic once a week. Then the patient will be reviewed monthly up to 12 months. After that the renal transplant patient will be seen by the renal physician 3 monthly for life-long time. However, the follow-up schedule will be individualised based on the patient well-being and the stability of kidney graft function. The patient will have surgical review in clinic between 4 -6 weeks after surgery to ensure there is no surgical complications. The final surgical review will be at 12 month after transplant. However, surgeons are available to review the patient whenever the concerns arise during renal transplant clinic follow-up.
Each follow-up session after a participant has been discharged will take approximately 30 minutes.
Intervention code [1] 288223 0
Treatment: Surgery
Comparator / control treatment
Conventional open kidney transplants from Jan 2012-update in the same institute
Control group
Historical

Outcomes
Primary outcome [1] 290823 0
Surgical time: on record form from the knife to skin to the skin closure completed
Timepoint [1] 290823 0
Immediate post-operation
Primary outcome [2] 290828 0
Graft function: by blood test of serum creatinine level.
Timepoint [2] 290828 0
From Day1 post-operation to the week 4 post-surgery. The daily blood test will be done in the first 5 days post-operation. Then, blood test 1-3 times a week from week 2-week 4.
Primary outcome [3] 290829 0
Dosage of Analgesia: by calculate of the analgesia drug chart.
Timepoint [3] 290829 0
The pain will be monitored on hourly basis from Immediate post-surgery to 48 hours of Post-surgery.
Secondary outcome [1] 305370 0
Surgical morbidity and Mortality.

The surgical morbidity will be analysed at the surgical clinic 4 weeks post-operation.

Surgical audit for mortality.
Timepoint [1] 305370 0
one month post-operation
Secondary outcome [2] 305402 0
Length of hospital stay by checking medical record.
Timepoint [2] 305402 0
one month post-operation
Secondary outcome [3] 305403 0
Long-term kidney graft function by recording creatinine level on blood test. The blood test will be done once a month when the kidney graft function stablised.
Timepoint [3] 305403 0
12 months post-operation

Eligibility
Key inclusion criteria
1. Kidney transplant recipients, medical assessment suitability for kidney transplant is completed prior to be listed.
2. Aged 18-60 years, BMI less than 32.5
3. Males or females
4. No history of significant abdominal surgery at lower abdomen.
5. All participants must read the participant information sheet and understand the potential risks and complications of the procedure.
6. Patient must be willing to sign informed consent form
7. Must be able to attend clinic visits.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unwilling or unable to sign informed consent form
2. Evidence of or history of bleeding disorder
3. Age over 60 years old or under 18 years old
4. The history of significant abdominal surgery such as inguinal hernia repair, large bowel resection etc.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2013
Actual
6/05/2013
Date of last participant enrolment
Anticipated
28/03/2019
Actual
Date of last data collection
Anticipated
28/03/2020
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288219 0
Hospital
Name [1] 288219 0
Sir Charles Gairdner Hospital
Country [1] 288219 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue, Nedlands, 6009, WA
Country
Australia
Secondary sponsor category [1] 286942 0
None
Name [1] 286942 0
Address [1] 286942 0
Country [1] 286942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290128 0
Human research ethic committee, Sir Charles Gairdner Hospital
Ethics committee address [1] 290128 0
Hospital Avenue, Nedlands, 6009, WA
Ethics committee country [1] 290128 0
Australia
Date submitted for ethics approval [1] 290128 0
29/05/2012
Approval date [1] 290128 0
28/03/2013
Ethics approval number [1] 290128 0
2012-099

Summary
Brief summary
The aim of this study is to apply the laparoscopic technique (key-hole surgery) to clinical human kidney transplant after successful pre-clinic experiment in the large animal pig model (RA/3/100/1040, UWA). In order to apply this laparoscopic technique safely to the human kidney transplant, The study has also being conducted on human cadaver body to define the ideal ports position. After successful application of laparoscopic technique in some cases of human kidney transplant, the randomised study will be considered in the near future to demonstrate the advantages of this new technique in clinical kidney transplant such as smaller incision, less pain, quicker recovery, shorter hospital stay, better cosmetics and equal graft function in comparison with routine open surgery.
Trial website
Trial related presentations / publications
1. He B et al. Establishment of training model on human cadaver body for laparoscopic kidney transplant. Exp Clin Transplant: (accepted in press).

2. He B et al. update of Laparoscopic/Robotic kidney transplant-literature review.
Transplant Research and Risk Management 2013; 5: 33-39.

3. He B et al. Laparoscopic surgery for orthotopic kidney transplant in the pig model. Journal of Surgical Research 2013; 184: 1096-1101.

4. He B, Mou L, Waneck G, Delriviere L. Laparoscopic Kidney Orthotopic Transplant: Pre-Clinic Study in Pig Model. Transplant Proceedings 2013; 45: 1776-1779.

5. He B, Musk G, Mou L, Waneck G, Delriviere L. Orthotopic kidney transplant by laparoscopic technique in the pig model. JSLS. 2013; Jan-March 17 (1): 126-31.
Public notes

Contacts
Principal investigator
Name 44102 0
A/Prof Bulang He
Address 44102 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands 6009, WA
Country 44102 0
Australia
Phone 44102 0
+61-8-9346 4055
Fax 44102 0
Email 44102 0
[email protected]
Contact person for public queries
Name 44103 0
A/Prof Bulang He
Address 44103 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands 6009, WA
Country 44103 0
Australia
Phone 44103 0
+61-8-9346-4055
Fax 44103 0
Email 44103 0
[email protected]
Contact person for scientific queries
Name 44104 0
A/Prof Bulang He
Address 44104 0
Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands 6009, WA
Country 44104 0
Australia
Phone 44104 0
+61-8-9346 4055
Fax 44104 0
Email 44104 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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