Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation
Application of the Biological Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplant
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Jalisco
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Guadalajara、Jalisco、メキシコ、44349
- Department of Transplantation. Specialties Hospital. Mexican Institute of Sociaql Security
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Guadalajara、Jalisco、メキシコ、44349
- Research Unit in Clinical Epidemiology, Specialties Hospital. Mexican Institute of Social Security
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients candidates to renal transplantation
Exclusion Criteria:
- Patients with known allergy to products of fibrin seal
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし:Control
Patients fron this group do not receive the fibrin sealant
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アクティブコンパレータ:Fibrin group
Patients from this group will receive the fibrin sealant
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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.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Postoperative Complications
時間枠:1 year
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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.
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1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Vascular Postoperative Complications
時間枠:1 year
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Identifying the different possible vascular postoperative complications:
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1 year
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Urological System Complication of Procedure
時間枠:1 year
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Identifying the different possible urological postoperative complications:
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1 year
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Lymphocele
時間枠:1 year
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Identifying the different possible lymphatic postoperative complications:
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1 year
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Postoperative Infection
時間枠:1 year
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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. |
1 year
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Alejandro Gonzalez-Ojeda, PhD、Instituto Mexicano del Seguro Social
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Fibrin Glueの臨床試験
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Cambridgeshire Community Services NHS TrustCambridge University Hospitals NHS Foundation Trustわからない
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Mashhad University of Medical Sciences募集