Trial Information

Application of the Biological Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplant

INTRODUCTION:

Globally there have been about 45,000 kidney transplants last year. Currently, the overall
survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major
challenge to overcome by the renal transplant surgeons, are surgical complications which may
impact on patient morbidity and mortality, as well as graft function.

Since 2000 to date the specialties Hospital from the Western Medical Center of the Mexican
Institute of Social Security, is the hospital where the greatest number of kidney
transplants are performed, reporting to December 2005 a total of 990 cases, with an average
of 200 transplants annually.

Since the completion of the first kidney transplants, there has emerged the presence of
complications related to the surgical procedure, which have influenced the morbidity and
mortality in transplant patients. Several factors are attributed to the occurrence of
postoperative complications, such as the patient's nutritional status, ischemic time,
presence of comorbidities, organ preservation, surgical technique, experience and skills of
the surgeon and the postoperative care.

The main causes of complications in the kidney transplants are: urological complications
such as urinary fistula, ureteral obstruction and ureteral necrosis (less than 7% of all
kidney transplants). Ischemia is the most common probable cause of urological complications
secondary to donor kidney extraction, anastomotic technique, variations in vascular supply,
rejection or medication. Vascular complications as early arterial thrombosis, renal vein
thrombosis and renal artery stenosis, are almost always due to a technical complication, or
are accompanied by twisting or bending of blood vessels during placement of the transplanted
kidney. Technical difficulties may be secondary to atherosclerotic disease in the donor or
receptor, or interact with multiple arteries. Lymphatic complications as lymphocele and
lymphatic fistula, after renal transplantation accumulation of lymphatic fluid
postoperatively are up to 15% of the patients. It is believed that the origin of the lymph
is in the destruction of perivascular normal lymph ducts during dissection, or destruction
of the hilar lymph.

Decreasing the incidence of surgical wound infection after renal transplantation is
multifactorial and is related to advances in the treatment of anemia, uremia, and general
health of patients with end-stage renal disease.

The seals are partly fibrin blood products and pharmacological agents. Their specific use is
as an adjunct to hemostasis as tissue adhesive. Seals are also developed as fibrin vehicle
to provide antimicrobial pharmacological agents, chemotherapeutic agents and growth factors.

They have the advantage of being products of human origin without tissue toxicity, which
promotes rapid fibrin seal. The seal is normally reabsorbed in days, promoting local tissue
growth and repair without increasing perioperative development of adhesions.

OBJECTIVE:

Assess whether application of fibrin seal prevents postoperative complications in patients
undergoing kidney transplantation.

MATERIAL AND METHODS:

Controlled clinical trial with single-blind evaluation in patients surgically intervened
kidney transplantation. It will include all patients undergoing renal transplantation in
this Medical Center, any gender and over than 16 years and under 60 years. Patients will be
excluded with allergy to the fibrin glue components. All the transplant procedure will be
made for the same surgical team.

The receptor site preparation will be done by addressing the retroperitoneal region of the
right lower quadrant of the abdomen with an incision Gibson type.

The patients are going to be distributed into two groups: Group 1: fibrin, Group 2: Control.
Complication weather vascular, urological, lymphatic, infectious, hospital stay and graft
loss will be assessed.

The receptor site preparation will be done by addressing the retroperitoneal region of the
right lower quadrant of the abdomen with an incision Gibson type.

The dissection of great vessels will be performed to achieve hemostasis of the blood vessels
and nodes, with electrocoagulation and ligation gauge nonabsorbable 3-0.

The vascular anastomosis will be made to the external iliac vessels of the receptor in
shaped end-side way, the suture material in size 6-0, in continuous sutures type with
nonabsorbable monofilament. The new ureteral anastomosis will be performed with the modified
technique of Leriche-Gregoire.

The new ureter will be tunneled and anastomosed to the mucosa with absorbable suture
material 4-0 (polyglactin). The biological adhesive will be applied to the study group, with
the spray technique in two atmospheres of pressure in a total amount of 10 ml. No biological
adhesive, placebo or simulated technique will be performed to the control group.

There will be placed a continuous suction drainage of closed silicone type, and the
abdominal wall will be closed with absorbable material in both groups.

Patients will be followed from the immediate postoperative period until discharge, and at
follow up every week the first month, then every 15 days the second month, and monthly until
one year follow up. During this follow-up, patients will be assessed through laboratory
tests that include complete blood count, blood chemistry with serial measurements of serum
creatinine, glomerular filtration rate, serum electrolytes and blood levels of
immunosuppressants. Also patients will be followed from the clinical point of view and if
there is any suspect for a complication, laboratory exams will be conducted such as crops,
urinalysis, determination of creatinine, noninvasive imaging studies such as Doppler
ultrasound, computed tomography, angiography if suspect on vascular complications.

STATISTICAL ANALYSIS:

Nominal variables were analyzed using percentage frequencies, X2 test or Fisher exact test.
Numeric variables using Student's t test for independent samples and ANOVA with post hoc
Scheffe test. U Mann Whitney and Kruskal Wallis tests will be used as long as data do not
conform to normal distribution.