None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.