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

Not Applicable

Completed

• Conditions: Nephrectomy
• Interventions: Procedure: Open nephrectomy; Procedure: Hand-assisted laparoscopic nephrectomy; Procedure: Laparoscopic nephrectomy

• Registration Number: NCT03717259
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-30
• Study First Submitted: 2018-06-26
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-21
• Last Update Submitted: 2018-10-21
• Study First Posted: 2018-10-24
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Open nephrectomy	Open nephrectomy	These patients will undergo an open nephrectomy.
Hand-assisted laparoscopic nephrectomy	Hand-assisted laparoscopic nephrectomy	These patients will undergo a hand-assisted nephrectomy.
Laparoscopic nephrectomy	Laparoscopic nephrectomy	These patients will undergo a pure laparoscopic nephrectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Days of hospital stay	30 days after the nephrectomy.	Differences in the days of hospital stay of the renal donor comparing the techniques used to obtain the graft.
Bleeding during the nephrectomy	Through the nephrectomy	The investigators will measure the volume of bleeding.
JJ catheter placement	Perioperative (5 days post surgery)	The investigators will describe the number of patients who underwent a JJ catheter.
Serum creatinine	Days post trasplant 1, 5 and 28.	Measurement of serum creatinine in kidney transplant patients.
Duration of the nephrectomy in minutes	Minutes from the beginning to the end of the nephrectomy	The investigators will measure how long the nephrectomies lasts
Warm ischemia time in the graft	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