Minimally Invasive Kidney Transplantation
1 other identifier
observational
90
0 countries
N/A
Brief Summary
This study aims to investigate the effect of robot-assisted laparoscopic kidney transplantation on kidney injury by measuring biomarkers of kidney injury which are found in blood and urine to establish if there is a significant difference between robotic and open surgery. The study will also investigate the potential benefits of minimally invasive surgery on the surgical trauma associated with open surgery by assessing the surgical stress response between groups of kidney transplant patients receiving either open or minimally invasive kidney transplants and by comparing wound healing with patients undergoing donor nephrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 26, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 31, 2017
October 1, 2017
1 year
October 24, 2017
October 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Expression of biomarkers of kidney injury
KIM-1, NGAL and Interleukin 18 will be measured pre-op and post operatively up to day 30.
30 days post op
Secondary Outcomes (1)
Wound healing
3 time points post op up to 14 days.
Study Arms (3)
Robotic-assisted kidney transplant
Adult patients undergoing robotic kidney transplantation. The transplant operation will be undertaken using the da Vinci systems robot in minimally invasive fashion.
Open kidney transplant
Adult patients undergoing kidney transplantation via an open approach.
Donor nephrectomy
Adult patients undergoing donor nephrectomy will have a scan of their abdominal wound to compare wound healing.
Interventions
Transplantation of a kidney either by open surgery or robotic assisted laparoscopic surgery.
Eligibility Criteria
Renal failure patients and donors
You may qualify if:
- patients over 18 years recieving a living donor kidney transplant at our institution
You may not qualify if:
- refuses consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
serum, plasma, urine
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nizam Mamode
Guy's and St Thomas' NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 26, 2017
Study Start
December 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2020
Last Updated
October 31, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share