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

Nephrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717259
• Other study ID #: Post_transplant_2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 30, 2017

Study information

• Verified date: October 2018
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: December 30, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Nephrectomy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

References & Publications (26)

Alfonzo JP. Four decades of kidney transplantation in Cuba. MEDICC Rev. 2013 Jan;15(1):23-8. Review. — View Citation

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. — View Citation

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

Cabral JF, Braga I, Fraga A, Castro-Henriques A, Príncipe 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. — View Citation

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. — View Citation

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Fabián JF, Mancilla E, Aburto JS, Kasep J, Lopez JO, Almaguer F, Basilio CI, García 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. — View Citation

Fonouni H, Mehrabi A, Golriz M, Zeier M, Müller-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. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

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Kälble 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. Review. — View Citation

Mallafré Sala JM. [Living donor nephrectomy for kidney transplantation]. Arch Esp Urol. 2005 Jul-Aug;58(6):517-20. Spanish. — View Citation

Matevossian E, Kern H, Hüser N, Doll D, Snopok Y, Nährig 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pérez Fentes DA, Blanco Parra M, Toucedo Caamaño V, Romero Burgos R, Puñal Rodríguez JA, Varo Pérez E. [Surgical complications after kidney transplantation. Research based on 185 cases]. Actas Urol Esp. 2005 Jun;29(6):578-86. Spanish. — View Citation

Rojas-Manjarrez MA, Fernández-Díaz OF, Sandoval-Sandoval MJ, Valdespino-Mejía C, Monteón-Ramos F, González-Ojeda A. [Urological complications after kidney transplantation]. Cir Cir. 2008 Mar-Apr;76(2):133-7. Spanish. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Villeda-Sandoval CI, Rodríguez-Covarrubias F, Cortés-Aguilar G, Alberú-Gómez J, Vilatobá-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. — View Citation

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. Review. — View Citation

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Bleeding during the nephrectomy	The investigators will measure the volume of bleeding.	Through the nephrectomy
Secondary	JJ catheter placement	The investigators will describe the number of patients who underwent a JJ catheter.	Perioperative (5 days post surgery)
Secondary	Serum creatinine	Measurement of serum creatinine in kidney transplant patients.	Days post trasplant 1, 5 and 28.
Secondary	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
Secondary	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