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OpenTrials
Completed

NCT Number: NCT03717259

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

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.

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Key information

Conditions

Nephrectomy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open nephrectomy

Procedure

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.

Hand-assisted laparoscopic nephrectomy

Procedure

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.

Laparoscopic nephrectomy

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2018
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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