NephrectomyNCT03717259
Recovery of Short-term Renal Function in Post-transplant Patients Living Donor
A study testing Open nephrectomy, Hand-assisted laparoscopic nephrectomy and Laparoscopic nephrectomy in people with Nephrectomy, run by Instituto Mexicano del Seguro Social.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nephrectomy
- What is being tested?
- Open nephrectomy, Hand-assisted laparoscopic nephrectomy and Laparoscopic nephrectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who for some reason can not find your complete medical record.
- Patients obtained a kidney graft from a brain death donor.
About this study
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
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.
Read the 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.
- Conditions
- Nephrectomy
- Being tested
- Open nephrectomy, Hand-assisted laparoscopic nephrectomy, Laparoscopic nephrectomy
- Keywords
- Renal Donation, Renal Transplant, Open Nephrectomy, Laparoscopic Nephrectomy, Hand Assisted, Surgical Morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open nephrectomyProcedure or surgery
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 nephrectomyProcedure or surgery
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 nephrectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Open nephrectomy | Active comparator | These patients will undergo an open nephrectomy. Receives: Procedure: Open nephrectomy |
| Hand-assisted laparoscopic nephrectomy | Active comparator | These patients will undergo a hand-assisted nephrectomy. Receives: Procedure: Hand-assisted laparoscopic nephrectomy |
| Laparoscopic nephrectomy | Active comparator | These patients will undergo a pure laparoscopic nephrectomy. Receives: Procedure: Laparoscopic nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 30 days post surgery.
Secondary outcomes (6)
Days of hospital stay
Differences in the days of hospital stay of the renal donor comparing the techniques used to obtain the graft.
Measured: 30 days after the nephrectomy.
Bleeding during the nephrectomy
The investigators will measure the volume of bleeding.
Measured: Through the nephrectomy
JJ catheter placement
The investigators will describe the number of patients who underwent a JJ catheter.
Measured: Perioperative (5 days post surgery)
Serum creatinine
Measurement of serum creatinine in kidney transplant patients.
Measured: Days post trasplant 1, 5 and 28.
Duration of the nephrectomy in minutes
The investigators will measure how long the nephrectomies lasts
Measured: 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
Measured: Time in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Jan 2016
- Primary completion1 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social
- Investigators
- José Antonio Sánchez Martínez, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security InstituteRoberto Martínez De Pinillos Valverde, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security InstituteEduardo González-Espinoza, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security InstituteClotilde Fuentes Orozco, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security InstituteRoberto Mares País, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security InstituteFrancisco José Barbosa Camacho, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security InstituteDiego Andrés Gallardo Vega, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security InstituteAlejandro González Ojeda, MD, Principal investigator, High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717259
- Sponsor's protocol ID
- Post_transplant_2016
- Status last verified
- Oct 2018
- First submitted
- 26 Jun 2018
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24182788Altinel 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.
PubMed 21486597Chin 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.
PubMed 19651070Rojas-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.
PubMed 18492434Perez 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.
PubMed 16092682Wolf 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.
PubMed 9801121Kalble 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.
PubMed 15661409Emery 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.
PubMed 2116995Stifelman 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.
PubMed 11458044Nogueira 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.
PubMed 10096529Meyer 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.
PubMed 22951178Simforoosh 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.
PubMed 15794797Hoda 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.
PubMed 20173371Fonouni 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.
PubMed 24770877Nanidis 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.
PubMed 18156924
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03717259
- Acronym / sponsor ID
- Post_transplant_2016
- Conditions
- Nephrectomy
- Keywords
- Renal Donation, Renal Transplant, Open Nephrectomy, Laparoscopic Nephrectomy, Hand Assisted, Surgical Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open nephrectomy | Active comparator | Procedure: Open nephrectomyThese patients will undergo an open nephrectomy. |
| Hand-assisted laparoscopic nephrectomy | Active comparator | Procedure: Hand-assisted laparoscopic nephrectomyThese patients will undergo a hand-assisted nephrectomy. |
| Laparoscopic nephrectomy | Active comparator | Procedure: Laparoscopic nephrectomyThese patients will undergo a pure laparoscopic nephrectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who for some reason can not find your complete medical record.
- Patients obtained a kidney graft from a brain death donor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open nephrectomyThe 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. | Procedure or surgery | Open nephrectomy |
| Hand-assisted laparoscopic nephrectomyThe 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. | Procedure or surgery | Hand-assisted laparoscopic nephrectomy |
| Laparoscopic nephrectomyIn 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. | Procedure or surgery | Laparoscopic nephrectomy |
Primary outcome
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.
6 secondary outcomes
Days of hospital stay
Time frame: 30 days after the nephrectomy.
Bleeding during the nephrectomy
Time frame: Through the nephrectomy
JJ catheter placement
Time frame: Perioperative (5 days post surgery)
Serum creatinine
Time frame: Days post trasplant 1, 5 and 28.
Duration of the nephrectomy in minutes
Time frame: Minutes from the beginning to the end of the nephrectomy
Warm ischemia time in the graft
Time frame: Time in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º C
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Background: PubMed 24182788Villeda-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.
- Background: PubMed 21486597Altinel 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.
- Background: PubMed 19651070Chin 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.
- Background: PubMed 18492434Rojas-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.
- Background: PubMed 16092682Perez 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.
- Background: PubMed 9801121Wolf 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.
- Background: PubMed 15661409Kalble 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.
- Background: PubMed 2116995Emery 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.
- Background: PubMed 11458044Stifelman 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.
- Background: PubMed 10096529Nogueira 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.
- Background: PubMed 22951178Meyer 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.
- Background: PubMed 15794797Simforoosh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Antonio Sánchez Martínez, MD principal investigator
High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Roberto Martínez De Pinillos Valverde, MD principal investigator
High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Eduardo González-Espinoza, MD principal investigator
High Specialty Medical Unit, National Western Medical Center, Mexican Social Security Institute
Questions about this trial
What is this clinical trial studying?
A study testing Open nephrectomy, Hand-assisted laparoscopic nephrectomy and Laparoscopic nephrectomy in people with Nephrectomy, run by Instituto Mexicano del Seguro Social.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of medical complications in renal graft recipients through 30 day after the nephrectomy. (time frame: Through 30 days post surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03717259, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.