Surgery Clinical Trial
Official title:
Evaluation Trifecta and Pentafecta Outcomes of Patients Underwent Laparoscopic Partial Nephrectomy for cT1 Renal Tumor
Verified date | December 2019 |
Source | Samsun Liv Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.
Status | Completed |
Enrollment | 292 |
Est. completion date | November 10, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 82 Years |
Eligibility |
Inclusion Criteria: - Functioning contraleteral kidney - Patients with complete data - Patients with single renal tumor on the effected side - Patients who approved the written consent form Exclusion Criteria: - The patients with bilateral renal tumors (n=8, 16 LPNs) - solitary kidney (n=8) - horseshoe kidney (n=4) - pelvic ectopic kidney (n=2) - graft kidney (n=2) - those with multiple renal tumors in a single kidney (n=3) or with > 7 cm renal tumor (n=6) - Patients who were operated on for colon cancer (n=4), prostate cancer (n=2), endometrial cancer (n=1) or adrenal mass (n=2) within the first year after LPN |
Country | Name | City | State |
---|---|---|---|
Turkey | Liv hospital samsun | Samsun | |
Turkey | Ondokuz Mayis University | Samsun |
Lead Sponsor | Collaborator |
---|---|
Samsun Liv Hospital | Ondokuz Mayis University |
Turkey,
Minervini A, Siena G, Antonelli A, Bianchi G, Bocciardi AM, Cosciani Cunico S, Ficarra V, Fiori C, Fusco F, Mari A, Martorana G, Medica M, Mirone V, Morgia G, Porpiglia F, Rocco F, Rovereto B, Schiavina R, Simeone C, Terrone C, Volpe A, Carini M, Serni S; — View Citation
Osaka K, Makiyama K, Nakaigawa N, Yao M. Predictors of trifecta outcomes in laparoscopic partial nephrectomy for clinical T1a renal masses. Int J Urol. 2015 Nov;22(11):1000-5. doi: 10.1111/iju.12893. Epub 2015 Aug 6. — View Citation
Porpiglia F, Bertolo R, Amparore D, Fiori C. Margins, ischaemia and complications rate after laparoscopic partial nephrectomy: impact of learning curve and tumour anatomical characteristics. BJU Int. 2013 Dec;112(8):1125-32. doi: 10.1111/bju.12317. Epub 2 — View Citation
Rais-Bahrami S, Romero FR, Lima GC, Kohanim S, Permpongkosol S, Trock BJ, Jarrett TW, Kavoussi LR. Elective laparoscopic partial nephrectomy in patients with tumors >4 cm. Urology. 2008 Sep;72(3):580-3. doi: 10.1016/j.urology.2008.05.027. Epub 2008 Jul 16 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operation time | time from onset to complete of surgery | at the end of the surgery | |
Primary | Blood loss | amount of bleeding during surgery (mL) | at the end of the surgery | |
Primary | warm ischemia time | The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy | at the and of the surgery | |
Primary | intraoperative complication | abnormal problmes that may be seen during surgery | at the end of the surgery | |
Primary | Postoperative complication | abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up | up to 3 months | |
Primary | functional outcomes | serum creatinine level and estimated glomerular filtration rate | up to 1 year postoperatively | |
Primary | surigcal margin status | presence or absence of tumors at the surgical margin | up to 1 month postoperatively | |
Primary | Relative decrease in renal function | Comparison of preoperative and postoperative renal functions according to numerical and percentile values | up to 1 year postoperatively | |
Primary | CKD stage upgrading | evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages | up to 1 year postoperatively | |
Primary | Oncological outomes | Presence or absence of local and/or distal tumor recurrence | up to the last clinical control (months) |
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