Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation
Condition: Vascular Postoperative Complications; Urological System Complication of Procedure; Lymphocele; Postoperative Infection
MeSH terms: Lymphocele; Postoperative Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      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.

      The aim of the study is to assess whether application of fibrin seal prevents postoperative
      complications in patients undergoing kidney transplantation.

      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.
    

Detailed description: 
      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.
    

Intervention name(s): Fibrin Glue
Intervention type(s): Biological
Intervention description(s): 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.
Other intervention name(s): Tissucol 10 ml (Baxter)
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fibrin sealant; renal transplantation; surgical complication