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临床试验/NCT01631448
NCT01631448已完成3 期

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

Alejandro Gonzalez-Ojeda4 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
152
试验地点
4
主要终点
Postoperative Complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients candidates to renal transplantation

排除标准

  • Patients with known allergy to products of fibrin seal

研究组 & 干预措施

Control

No Intervention

Patients fron this group do not receive the fibrin sealant

结局指标

主要结局

Postoperative Complications

时间窗: 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.

次要结局

  • Postoperative Infection(1 year)
  • Vascular Postoperative Complications(1 year)
  • Urological System Complication of Procedure(1 year)
  • Lymphocele(1 year)

研究者

发起方
Alejandro Gonzalez-Ojeda
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Alejandro Gonzalez-Ojeda

PhD

Instituto Mexicano del Seguro Social

研究点 (4)

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