Clinical trial NCT03717259: Recovery of Short-term Renal Function in Post-transplant Patients Living Donor
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrectomy
Keywords: Renal Donation
Renal Transplant
Open Nephrectomy
Laparoscopic Nephrectomy
Hand Assisted
Surgical Morbidity
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2018-10-24
Enrollment: 508
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of medical complications in renal graft recipients through 30 day after the nephrectomy.
timeFrame: Through 30 days post surgery.
Secondary outcomes:
measure: Days of hospital stay
timeFrame: 30 days after the nephrectomy.
measure: Bleeding during the nephrectomy
timeFrame: Through the nephrectomy
measure: JJ catheter placement
timeFrame: Perioperative (5 days post surgery)
measure: Serum creatinine
timeFrame: Days post trasplant 1, 5 and 28.
measure: Duration of the nephrectomy in minutes
timeFrame: Minutes from the beginning to the end of the nephrectomy
measure: Warm ischemia time in the graft
timeFrame: Time in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º C
Other outcomes:
Locations:
Study officials:
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: José Antonio Sánchez Martínez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Roberto Martínez De Pinillos Valverde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Eduardo González-Espinoza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Clotilde Fuentes Orozco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Roberto Mares País, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Francisco José Barbosa Camacho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Diego Andrés Gallardo Vega, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
name: Alejandro González Ojeda, MD
role: PRINCIPAL_INVESTIGATOR
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