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

NCT03717259 | Completed DMC

• 1 other identifier: Post_transplant_2016
• Study Type: interventional
• Target: 508
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nephrectomy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Through 30 days post surgery.

Secondary Outcomes (6)

• Days of hospital stay

  30 days after the nephrectomy.

• Bleeding during the nephrectomy

  Through the nephrectomy

• JJ catheter placement

  Perioperative (5 days post surgery)

• Serum creatinine

  Days post trasplant 1, 5 and 28.

• Duration of the nephrectomy in minutes

  Minutes from the beginning to the end of the nephrectomy

Study Arms (3)

Open nephrectomy

ACTIVE COMPARATOR

These patients will undergo an open nephrectomy.

Procedure: Open nephrectomy

Hand-assisted laparoscopic nephrectomy

ACTIVE COMPARATOR

These patients will undergo a hand-assisted nephrectomy.

Procedure: Hand-assisted laparoscopic nephrectomy

Laparoscopic nephrectomy

ACTIVE COMPARATOR

These patients will undergo a pure laparoscopic nephrectomy.

Procedure: Laparoscopic nephrectomy

Interventions

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.

Open nephrectomy

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.

Hand-assisted laparoscopic nephrectomy

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.

Laparoscopic nephrectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who for some reason can not find your complete medical record.
• Patients obtained a kidney graft from a brain death donor.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Related Publications (26)

• Villeda-Sandoval CI, Rodriguez-Covarrubias F, Cortes-Aguilar G, Alberu-Gomez J, Vilatoba-Chapa M, Sotomayor M, Feria-Bernal G, Gabilondo F, Gabilondo-Pliego B. Hand-assisted laparoscopic versus open donor nephrectomy: a retrospective comparison of perioperative and functional results in a tertiary care center in Mexico. Transplant Proc. 2013 Nov;45(9):3220-4. doi: 10.1016/j.transproceed.2013.03.055.

  PMID: 24182788 BACKGROUND

• Altinel M, Akinci S, Gunes ZE, Olcucuoglu E, Gonenc F, Yazicioglu AH. Open versus laparoscopic donor nephrectomy: perioperative parameters and graft functions. Transplant Proc. 2011 Apr;43(3):781-6. doi: 10.1016/j.transproceed.2011.01.113.

  PMID: 21486597 BACKGROUND

• Chin EH, Hazzan D, Edye M, Wisnivesky JP, Herron DM, Ames SA, Palese M, Pomp A, Gagner M, Bromberg JS. The first decade of a laparoscopic donor nephrectomy program: effect of surgeon and institution experience with 512 cases from 1996 to 2006. J Am Coll Surg. 2009 Jul;209(1):106-13. doi: 10.1016/j.jamcollsurg.2009.02.060. Epub 2009 May 1.

  PMID: 19651070 BACKGROUND

• Rojas-Manjarrez MA, Fernandez-Diaz OF, Sandoval-Sandoval MJ, Valdespino-Mejia C, Monteon-Ramos F, Gonzalez-Ojeda A. [Urological complications after kidney transplantation]. Cir Cir. 2008 Mar-Apr;76(2):133-7. Spanish.

  PMID: 18492434 BACKGROUND

• Perez Fentes DA, Blanco Parra M, Toucedo Caamano V, Romero Burgos R, Punal Rodriguez JA, Varo Perez E. [Surgical complications after kidney transplantation. Research based on 185 cases]. Actas Urol Esp. 2005 Jun;29(6):578-86. doi: 10.1016/s0210-4806(05)73300-3. Spanish.

  PMID: 16092682 BACKGROUND

• Wolf JS Jr, Tchetgen MB, Merion RM. Hand-assisted laparoscopic live donor nephrectomy. Urology. 1998 Nov;52(5):885-7. doi: 10.1016/s0090-4295(98)00389-6.

  PMID: 9801121 BACKGROUND

• Kalble T, Lucan M, Nicita G, Sells R, Burgos Revilla FJ, Wiesel M; European Association of Urology. EAU guidelines on renal transplantation. Eur Urol. 2005 Feb;47(2):156-66. doi: 10.1016/j.eururo.2004.02.009.

  PMID: 15661409 BACKGROUND

• Emery DL, Rothel JS, Wood PR. Influence of antigens and adjuvants on the production of gamma-interferon and antibody by ovine lymphocytes. Immunol Cell Biol. 1990 Apr;68 ( Pt 2):127-36. doi: 10.1038/icb.1990.18.

  PMID: 2116995 BACKGROUND

• Stifelman MD, Hull D, Sosa RE, Su LM, Hyman M, Stubenbord W, Shichman S. Hand assisted laparoscopic donor nephrectomy: a comparison with the open approach. J Urol. 2001 Aug;166(2):444-8. doi: 10.1016/s0022-5347(05)65960-5.

  PMID: 11458044 BACKGROUND

• Nogueira JM, Cangro CB, Fink JC, Schweitzer E, Wiland A, Klassen DK, Gardner J, Flowers J, Jacobs S, Cho E, Philosophe B, Bartlett ST, Weir MR. A comparison of recipient renal outcomes with laparoscopic versus open live donor nephrectomy. Transplantation. 1999 Mar 15;67(5):722-8. doi: 10.1097/00007890-199903150-00014.

  PMID: 10096529 BACKGROUND

• Meyer F, Nichele SA, Adamy A, Santos LS, Machado C. Early outcomes of laparoscopic donor nephrectomy with multiple renal arteries. Int Braz J Urol. 2012 Jul-Aug;38(4):496-503. doi: 10.1590/s1677-55382012000400009.

  PMID: 22951178 BACKGROUND

• Simforoosh N, Basiri A, Tabibi A, Shakhssalim N, Hosseini Moghaddam SM. Comparison of laparoscopic and open donor nephrectomy: a randomized controlled trial. BJU Int. 2005 Apr;95(6):851-5. doi: 10.1111/j.1464-410X.2005.05415.x.

  PMID: 15794797 BACKGROUND

• Hoda MR, Hamza A, Greco F, Wagner S, Fischer K, Fornara P. Early and late graft function after laparoscopic hand-assisted donor nephrectomy for living kidney transplantation: comparison with open donor nephrectomy. Urol Int. 2010;84(1):61-6. doi: 10.1159/000273468. Epub 2010 Feb 17.

  PMID: 20173371 BACKGROUND

• Fonouni H, Mehrabi A, Golriz M, Zeier M, Muller-Stich BP, Schemmer P, Werner J. Comparison of the laparoscopic versus open live donor nephrectomy: an overview of surgical complications and outcome. Langenbecks Arch Surg. 2014 Jun;399(5):543-51. doi: 10.1007/s00423-014-1196-4. Epub 2014 Apr 28.

  PMID: 24770877 BACKGROUND

• Nanidis TG, Antcliffe D, Kokkinos C, Borysiewicz CA, Darzi AW, Tekkis PP, Papalois VE. Laparoscopic versus open live donor nephrectomy in renal transplantation: a meta-analysis. Ann Surg. 2008 Jan;247(1):58-70. doi: 10.1097/SLA.0b013e318153fd13.

  PMID: 18156924 BACKGROUND

• Ungbhakorn P, Kongchareonsombat W, Leenanupan C, Kijvikai K, Wisetsingh W, Patcharatrakul S, Jirasiritam S. Comparative outcomes of open nephrectomy, hand-assisted laparoscopic nephrectomy, and full laparoscopic nephrectomy for living donors. Transplant Proc. 2012 Jan;44(1):22-5. doi: 10.1016/j.transproceed.2011.12.026.

  PMID: 22310568 BACKGROUND

• Jacobsson A, Nedergaard J, Cannon B. alpha- and beta-adrenergic control of thermogenin mRNA expression in brown adipose tissue. Biosci Rep. 1986 Jul;6(7):621-31. doi: 10.1007/BF01114756.

  PMID: 3022838 BACKGROUND

• Garcia-Garcia G, Renoirte-Lopez K, Marquez-Magana I. Disparities in renal care in Jalisco, Mexico. Semin Nephrol. 2010 Jan;30(1):3-7. doi: 10.1016/j.semnephrol.2009.10.001.

  PMID: 20116641 BACKGROUND

• Mallafre Sala JM. [Living donor nephrectomy for kidney transplantation]. Arch Esp Urol. 2005 Jul-Aug;58(6):517-20. doi: 10.4321/s0004-06142005000600008. Spanish.

  PMID: 16138763 BACKGROUND

• Fabian JF, Mancilla E, Aburto JS, Kasep J, Lopez JO, Almaguer F, Basilio CI, Garcia HB, Arcos AG. Hand-Assisted Laparoscopic Nephrectomy for Live Donor Kidney Transplantation. Transplant Proc. 2016 Mar;48(2):568-71. doi: 10.1016/j.transproceed.2016.02.020.

  PMID: 27110004 BACKGROUND

• Greco F, Hoda MR, Alcaraz A, Bachmann A, Hakenberg OW, Fornara P. Laparoscopic living-donor nephrectomy: analysis of the existing literature. Eur Urol. 2010 Oct;58(4):498-509. doi: 10.1016/j.eururo.2010.04.003. Epub 2010 Apr 18.

  PMID: 20417024 BACKGROUND

• Alfonzo JP. Four decades of kidney transplantation in Cuba. MEDICC Rev. 2013 Jan;15(1):23-8. doi: 10.37757/MR2013V15.N1.6.

  PMID: 23396238 BACKGROUND

• Matevossian E, Kern H, Huser N, Doll D, Snopok Y, Nahrig J, Altomonte J, Sinicina I, Friess H, Thorban S. Surgeon Yurii Voronoy (1895-1961) - a pioneer in the history of clinical transplantation: in memoriam at the 75th anniversary of the first human kidney transplantation. Transpl Int. 2009 Dec;22(12):1132-9. doi: 10.1111/j.1432-2277.2009.00986.x. No abstract available.

  PMID: 19874569 BACKGROUND

• Barker CF, Markmann JF. Historical overview of transplantation. Cold Spring Harb Perspect Med. 2013 Apr 1;3(4):a014977. doi: 10.1101/cshperspect.a014977.

  PMID: 23545575 BACKGROUND

• Wilson CH, Sanni A, Rix DA, Soomro NA. Laparoscopic versus open nephrectomy for live kidney donors. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD006124. doi: 10.1002/14651858.CD006124.pub2.

  PMID: 22071829 BACKGROUND

• Cabral JF, Braga I, Fraga A, Castro-Henriques A, Principe P, Silva-Ramos M. From Open to Laparoscopic Living-donor Nephrectomy: Changing the Paradigm in a High-volume Transplant Center. Transplant Proc. 2015 May;47(4):903-5. doi: 10.1016/j.transproceed.2015.03.037.

  PMID: 26036482 BACKGROUND

Study Officials

• José Antonio Sánchez Martínez, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Roberto Martínez De Pinillos Valverde, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Eduardo González-Espinoza, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Clotilde Fuentes Orozco, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Roberto Mares País, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Francisco José Barbosa Camacho, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Diego Andrés Gallardo Vega, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

• Alejandro González Ojeda, MD

  High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time surgical researcher

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: October 24, 2018
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 30, 2017
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share