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Clinical Trials/NCT03717259
NCT03717259CompletedNot Applicable

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

Instituto Mexicano del Seguro Social0 sites508 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
508
Primary Endpoint
Rate of medical complications in renal graft recipients through 30 day after the nephrectomy.

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts 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.

Arms & Interventions

Open nephrectomy

Active Comparator

These patients will undergo an open nephrectomy.

Intervention: Open nephrectomy (Procedure)

Hand-assisted laparoscopic nephrectomy

Active Comparator

These patients will undergo a hand-assisted nephrectomy.

Intervention: Hand-assisted laparoscopic nephrectomy (Procedure)

Laparoscopic nephrectomy

Active Comparator

These patients will undergo a pure laparoscopic nephrectomy.

Intervention: Laparoscopic nephrectomy (Procedure)

Outcomes

Primary Outcomes

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

  • Duration of the nephrectomy in minutes(Minutes from the beginning to the end of the nephrectomy)
  • 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)
  • Serum creatinine(Days post trasplant 1, 5 and 28.)
  • Days of hospital stay(30 days after the nephrectomy.)
  • Bleeding during the nephrectomy(Through the nephrectomy)
  • JJ catheter placement(Perioperative (5 days post surgery))

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Alejandro Gonzalez-Ojeda

Full time surgical researcher

Instituto Mexicano del Seguro Social

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