Clinical Trial: Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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
Sponsor: Alejandro Gonzalez-Ojeda

Current Primary Outcome: Postoperative Complications [ Time Frame: 1 year ]

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. Identifying any kind of complication derived from the surgical procedure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Vascular Postoperative Complications [ Time Frame: 1 year ]

    Identifying the different possible vascular postoperative complications:

    • Renal artery stenosis: The narrowing of the light by 30% diagnosed by Doppler ecosonography and corroborated by arteriography.
    • Renal vein stenosis: The narrowing of light> 40% of the renal vein Doppler and confirmed by venography ecosonography graft.
    • Arterial thrombosis: The total occlusion of the renal artery lumen by a thrombus, which prevents blood perfusion of the kidney, diagnosed by Doppler and arteriography of the graft.
  • Urological System Complication of Procedure [ Time Frame: 1 year ]

    Identifying the different possible urological postoperative complications:

    • Urinary Fistula: The loss of continuity of the ureterovesical anastomosis with formation of a journey outward, allowing the escape of urine into the preperitoneal region at the site of graft placement.
    • Ureteral obstruction: Stopping or reducing the passage of urine into the bladder through the ureter at the ureterovesical anastomosis, which is given by hyperplasia at the site.
    • Ureteral necrosis: devitalization of the ureter as a result of devascularization, with loss of functionality and feasibility.
  • Lymphocele [ Time Frame: 1 year ]

    Identifying the different possible lymphatic postoperative complications:

    • Lymphocele: encapsulated collection of lymphatic fluid in postoperative graft site.
    • Lymphatic fistula: Leakage of lymph fluid with formation of a journey to the outside of the surgical wound.
  • Postoperative Infection [ Time Frame: 1 year ]

    Identifying the different possible infectious postoperative complications:

    *Surgical wound infection: Signs of wound infection, like redness, heat, increased local temperature and swelling of the wound. If the drain or treat this is limited, the subcutaneous tissue infection was considered superficial infection of the surgical site, if any collection of pus in the thickness of wound without involvement of the surgical wound abscess be known. If there is necrosis necrotizing myofasciitis be called.



Original Secondary Outcome: Same as current

Information By: Instituto Mexicano del Seguro Social

Dates:
Date Received: June 27, 2012
Date Started: May 2010
Date Completion:
Last Updated: March 23, 2015
Last Verified: March 2015