Recovery of Short-term Renal Function in Post-transplant Patients Living Donor

Study Overview
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Brief Summary
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Objectives: To describe and analyze the perioperative and functional evolution of short-term renal graft in patients with kidney transplantation from a live donor, comparing three surgical techniques for obtaining kidney graft: open nephrectomy, laparoscopic hand-assisted nephrectomy, and pure laparoscopic nephrectomy.

Detailed Description
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Analytical cross-sectional study that will compare the three renal graft procurement techniques: open nephrectomy, laparoscopic hand-assisted nephrectomy, and pure laparoscopic nephrectomy. The investigators will analyze serum creatinine values on days 1, 5 and 28 post renal transplantation. The operative, medical and surgical morbidity will also be evaluated, considering the bleeding in the donor, times of ischemia and the need for JJ catheter placement in the recipient.

Official Title
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Recovery of Short-term Renal Function in Post-transplant Patients Living Donor: Comparison Between Graft Procurement Techniques - Open Surgery, Laparoscopic Assisted Hand and Pure Laparoscopic

Conditions
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Nephrectomy

Intervention / Treatment
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* Procedure: Open nephrectomy
* Procedure: Hand-assisted laparoscopic nephrectomy
* Procedure: Laparoscopic nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with terminal chronic kidney disease who will receive a kidney transplant in the transplant service of the National Medical Center of the West of living donor related to the means of obtaining the kidney graft by laparoscopic hand assisted or pure laparoscopic surgery. Exclusion Criteria: Patients who for some reason can not find your complete medical record. Patients obtained a kidney graft from a brain death donor.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is an analytical cross-sectional study for which patients with terminal chronic kidney disease will be taken from kidney transplanted from a related live donor in a tertiary hospital. The selection of patients will be done with a non-probabilistic sampling of consecutive cases. Kidney transplantation from a live donor will be carried out by means of kidney graft procurement techniques using open surgery, laparoscopic hand-assisted surgery or pure laparoscopic surgery. The statistical analysis will be performed with Student´s t-test and Chi-square test. To determine if the intervening variables affected the postoperative renal function, we will perform a multivariate analysis. We will consider a significant P value when it is <0.05.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open nephrectomy<br>These patients will undergo an open nephrectomy. | Procedure: Open nephrectomy<br>* The surgical technique for open nephrectomy consists of placing the donor in the lateral decubitus position and making an incision with or without rib resection that allows retroperitoneal access.<br>|
| Active Comparator: Hand-assisted laparoscopic nephrectomy<br>These patients will undergo a hand-assisted nephrectomy. | Procedure: Hand-assisted laparoscopic nephrectomy<br>* The hand-assisted technique begins with the incision for the introduction port of the hand, the renal artery and vein are divided using endoscopic staples and the graft is manually removed.<br>|
| Active Comparator: Laparoscopic nephrectomy<br>These patients will undergo a pure laparoscopic nephrectomy. | Procedure: Laparoscopic nephrectomy<br>* In the pure laparoscopic technique the patient is placed in the same position of lateral decubitus and after introducing the trocars in the abdomen, the colon is mobilized and the renal capsule is divided, the kidney is removed after performing the cut of the renal artery and vein through a suprapubic incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of medical complications in renal graft recipients through 30 day after the nephrectomy. | The investigators will evaluate the presence of surgical and medical complications in renal graft recipients obtained by open nephrectomy, hand assisted nephrectomy, and pure laparoscopic nephrectomy. | Through 30 days post surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of hospital stay | Differences in the days of hospital stay of the renal donor comparing the techniques used to obtain the graft. | 30 days after the nephrectomy. | 
| Bleeding during the nephrectomy | The investigators will measure the volume of bleeding. | Through the nephrectomy | 
| JJ catheter placement | The investigators will describe the number of patients who underwent a JJ catheter. | Perioperative (5 days post surgery) | 
| Serum creatinine | Measurement of serum creatinine in kidney transplant patients. | Days post trasplant 1, 5 and 28. | 
| Duration of the nephrectomy in minutes | The investigators will measure how long the nephrectomies lasts | Minutes from the beginning to the end of the nephrectomy | 
| Warm ischemia time in the graft | The investigators will measure the time of warm ischemia during nephrectomy | Time in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º C | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Donation, Renal Transplant, Open Nephrectomy, Laparoscopic Nephrectomy, Hand Assisted, Surgical Morbidity