Quality of Life in Pancreas Transplantation v1.0
Research type
Research Study
Full title
Prospective Longitudinal Observational Study on Insulin Dependent Diabetic Patients undergoing any form of Solid Organ Pancreas Transplantation aimed to clarify Quality of Life Changes after Pancreas Transplantation
IRAS ID
237706
Contact name
Irene Mosca
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Quality of Life in Pancreas Transplantation
This study aims to investigate quality of life changes in insulin dependent diabetic patients undergoing pancreas and/or kidney transplantation and to understand which patients could benefit the most/the least from this intervention.
There are 3.5 million diabetic people in the UK. Their life expectancy is reduced and their wellbeing is significantly impaired by complications such as cardiovascular disease, renal failure, retinopathy, neuropathy. Furthermore some of them experience sudden drop in blood glucose levels without warning sings, which is a life threatening emergency.
Solid organ Pancreas Transplantation restores insulin production but it is also burdened by high perioperative morbidity and mortality. It is widely recognised that the surgical risks must be weighted against clinical benefits as well as quality of life improvements.
In addition, quality of life studies are the framework used by health-care policy makers to allocate resources and evaluate efficacy and cost of clinical interventions.
After 50 years of pancreatic transplantation clinical benefits and risks have been extensively investigated, but our knowledge about quality of life gain is nearly anecdotal.
Patients listed for any form of Pancreatic Transplantation at Oxford Transplant Centre will be invited to participate in this study. Participants will be requested to complete quality of life questionnaires at given time-points pre- and up to one year post-transplantation, for a total of 4 (+1)* sets of questionnaires. The average waiting time for transplantation is about one year, hence patient’s commitment to the study will be of about 2 years.
The study will be part of a D-Phil research under the sponsorship of the University of Oxford and Funding will be provided by Chief Investigator's Research Fund within the Nuffield Department of Surgical Sciences.
*Patients remaining on the waiting list for over one year will be requested to complete a second pre-transplant set of questionnaires.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0385
Date of REC Opinion
17 Aug 2018
REC opinion
Favourable Opinion