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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717259
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nephrectomy Procedure: Open nephrectomy Procedure: Hand-assisted laparoscopic nephrectomy Procedure: Laparoscopic nephrectomy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 508 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Active Comparator: Open nephrectomy
These patients will undergo an open nephrectomy.
Procedure: Open nephrectomy
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.

Active Comparator: Hand-assisted laparoscopic nephrectomy
These patients will undergo a hand-assisted nephrectomy.
Procedure: Hand-assisted laparoscopic nephrectomy
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.

Active Comparator: Laparoscopic nephrectomy
These patients will undergo a pure laparoscopic nephrectomy.
Procedure: Laparoscopic nephrectomy
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.




Primary Outcome Measures :
  1. Rate of medical complications in renal graft recipients through 30 day after the nephrectomy. [ Time Frame: Through 30 days post surgery. ]
    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.


Secondary Outcome Measures :
  1. Days of hospital stay [ Time Frame: 30 days after the nephrectomy. ]
    Differences in the days of hospital stay of the renal donor comparing the techniques used to obtain the graft.

  2. Bleeding during the nephrectomy [ Time Frame: Through the nephrectomy ]
    The investigators will measure the volume of bleeding.

  3. JJ catheter placement [ Time Frame: Perioperative (5 days post surgery) ]
    The investigators will describe the number of patients who underwent a JJ catheter.

  4. Serum creatinine [ Time Frame: Days post trasplant 1, 5 and 28. ]
    Measurement of serum creatinine in kidney transplant patients.

  5. Duration of the nephrectomy in minutes [ Time Frame: Minutes from the beginning to the end of the nephrectomy ]
    The investigators will measure how long the nephrectomies lasts

  6. Warm ischemia time in the graft [ Time Frame: Time in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º C ]
    The investigators will measure the time of warm ischemia during nephrectomy



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717259


Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: José Antonio Sánchez Martínez, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Roberto Martínez De Pinillos Valverde, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Eduardo González-Espinoza, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Clotilde Fuentes Orozco, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Roberto Mares País, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Francisco José Barbosa Camacho, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Diego Andrés Gallardo Vega, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Principal Investigator: Alejandro González Ojeda, MD High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

Publications:

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Responsible Party: Alejandro Gonzalez-Ojeda, Full time surgical researcher, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT03717259    
Other Study ID Numbers: Post_transplant_2016
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social:
Renal Donation
Renal Transplant
Open Nephrectomy
Laparoscopic Nephrectomy
Hand Assisted
Surgical Morbidity