Rodney H Breau1,2, Dean A Fergusson2, Greg Knoll2,3, Kristen McAlpine1, Christopher Morash1, Sonya Cnossen2, Luke T Lavallée1,2, Ranjeeta Mallick2, Antonio Finelli4, Michael A S Jewett4, Bradley C Leibovich5, Jonathan A Cook6, Anil Kapoor7, Frederic Pouliot8, Jonathan Izawa9, Ricardo Rendon10, Ilias Cagiannos1. 1. Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada. 2. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 3. Division of Nephrology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada. 4. Departments of Surgery (Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto, Ontario, Canada. 5. Department of Urology, Mayo Clinic, Rochester, Minnesota. 6. Oxford Clinical Trial Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. 7. Division of Urology, McMaster University, Hamilton, Ontario, Canada. 8. Division of Urology, Université Laval, Quebec City, Québec, Canada. 9. Division of Urology, Department of Surgery, Western University, London, Ontario, Canada. 10. Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada.
Abstract
PURPOSE: Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy. MATERIALS AND METHODS: We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (controlgroup) during partial nephrectomy at 6 academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of 99mTc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10 ml/minute/1.73 m2 at a 5% significance level. RESULTS: Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/minute/1.73 m2). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1 year after surgery. The change in mGFR 1 year after surgery was -6.6 ml/minute/1.73 m2 in the hypothermia group and -7.8 ml/minute/1.73 m2 in the control group (mean difference 1.2 ml/minute/1.73 m2, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 ml/minute/1.73 m2; mean difference 0.5 ml/minute/1.73 m2, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life. CONCLUSIONS:Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function.
RCT Entities:
PURPOSE: Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy. MATERIALS AND METHODS: We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at 6 academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of 99mTc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10 ml/minute/1.73 m2 at a 5% significance level. RESULTS: Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/minute/1.73 m2). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1 year after surgery. The change in mGFR 1 year after surgery was -6.6 ml/minute/1.73 m2 in the hypothermia group and -7.8 ml/minute/1.73 m2 in the control group (mean difference 1.2 ml/minute/1.73 m2, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 ml/minute/1.73 m2; mean difference 0.5 ml/minute/1.73 m2, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life. CONCLUSIONS:Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function.
Entities:
Keywords:
general surgery; hypothermia; kidney neoplasms; randomized controlled trial
Authors: Theresa Junker; Louise Duus; Benjamin S B Rasmussen; Nessn Azawi; Lars Lund; Ole Graumann; Birgitte Nørgaard Journal: Syst Rev Date: 2022-01-04