Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717259
Enrollment
508
Registered
2018-10-24
Start date
2016-01-01
Completion date
2017-12-30
Last updated
2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrectomy

Keywords

Renal Donation, Renal Transplant, Open Nephrectomy, Laparoscopic Nephrectomy, Hand Assisted, Surgical Morbidity

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.

Interventions

PROCEDUREOpen 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.

PROCEDUREHand-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.

PROCEDURELaparoscopic 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.

Sponsors

Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of medical complications in renal graft recipients through 30 day after the nephrectomy.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

MeasureTime frameDescription
Bleeding during the nephrectomyThrough the nephrectomyThe investigators will measure the volume of bleeding.
JJ catheter placementPerioperative (5 days post surgery)The investigators will describe the number of patients who underwent a JJ catheter.
Days of hospital stay30 days after the nephrectomy.Differences in the days of hospital stay of the renal donor comparing the techniques used to obtain the graft.
Duration of the nephrectomy in minutesMinutes from the beginning to the end of the nephrectomyThe investigators will measure how long the nephrectomies lasts
Warm ischemia time in the graftTime in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º CThe investigators will measure the time of warm ischemia during nephrectomy
Serum creatinineDays post trasplant 1, 5 and 28.Measurement of serum creatinine in kidney transplant patients.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026