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

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.

Study Overview

• Status: Completed
• Conditions: Nephrectomy
• Intervention / Treatment: Procedure: Open nephrectomy; Procedure: Hand-assisted laparoscopic nephrectomy; Procedure: 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 Type: Interventional
• Enrollment (Actual): 508
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open nephrectomy; These patients will undergo an open nephrectomy.	Procedure: Open 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.
Active Comparator: Hand-assisted laparoscopic nephrectomy; These patients will undergo a hand-assisted nephrectomy.	Procedure: Hand-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.
Active Comparator: Laparoscopic nephrectomy; These patients will undergo a pure laparoscopic nephrectomy.	Procedure: Laparoscopic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of hospital stay	Differences in the days of hospital stay of the renal donor comparing the techniques used to obtain the graft.	30 days after the nephrectomy.
Bleeding during the nephrectomy	The investigators will measure the volume of bleeding.	Through the nephrectomy
JJ catheter placement	The investigators will describe the number of patients who underwent a JJ catheter.	Perioperative (5 days post surgery)
Serum creatinine	Measurement of serum creatinine in kidney transplant patients.	Days post trasplant 1, 5 and 28.
Duration of the nephrectomy in minutes	The investigators will measure how long the nephrectomies lasts	Minutes from the beginning to the end of the nephrectomy
Warm ischemia time in the graft	The investigators will measure the time of warm ischemia during nephrectomy	Time in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º C

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: 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: 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: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Alfonzo JP. Four decades of kidney transplantation in Cuba. MEDICC Rev. 2013 Jan;15(1):23-8. doi: 10.37757/MR2013V15.N1.6.
• 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.
• Barker CF, Markmann JF. Historical overview of transplantation. Cold Spring Harb Perspect Med. 2013 Apr 1;3(4):a014977. doi: 10.1101/cshperspect.a014977.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: October 21, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 21, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Laparoscopic Nephrectomy; Renal Transplant; Renal Donation; Open Nephrectomy; Hand Assisted; Surgical Morbidity
• Other Study ID Numbers: Post_transplant_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No