Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation
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.
|Vascular Postoperative Complications Urological System Complication of Procedure Lymphocele Postoperative Infection||Biological: Fibrin Glue||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Application of the Biological Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplant|
- 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.
- 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.
|Study Start Date:||May 2010|
|Study Completion Date:||March 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control
Patients fron this group do not receive the fibrin sealant
Active Comparator: Fibrin group
Patients from this group will receive the fibrin sealant
Biological: Fibrin Glue
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 Name: Tissucol 10 ml (Baxter)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01631448
|Department of Transplantation. Specialties Hospital. Mexican Institute of Sociaql Security|
|Guadalajara, Jalisco, Mexico, 44349|
|Research Unit in Clinical Epidemiology, Specialties Hospital. Mexican Institute of Social Security|
|Guadalajara, Jalisco, Mexico, 44349|
|Study Director:||Alejandro Gonzalez-Ojeda, PhD||Instituto Mexicano del Seguro Social|