To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.
To date, no studies have compared the outcomes of thulium beam coagulation versus suture renorrhaphy for hemostasis of tumor bed in laparoscopic partial nephrectomy in patients with small renal messes (SRMs). This study aims to compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy. The investigators hypothesize that: Conducted well designed, randomized prospective comparative study can help to identify which technique is better. Using thulium beam coagulation for hemostasis of the tumor bed in laparoscopic partial nephrectomy can improve the outcome, shorten intraoperative ischemia time and decrease blood loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Suture renorrhaphy will be used in 2 layers; medullary and cortical, with Vicry 2/0 or 3/0 and secured with V-lock. Early unclamping will be done after hemostasis of the medullary layer. Renorrhaphy of the cortical layer will be continued after that.
A 2-μm continuous thulium laser with 365 μm laser fiber at 30-40 W will be used for coagulation of the tumor bed. Large vessels that may not be completely sealed with thulium beam will be closed by V-lock to achieve safe and stable hemostasis. Early unclamping will be done after hemostasis of the tumor bed. Suture renorrhaphy will be used in 1 layer to approximate the renal parenchyma.
Urology Department, Al-Azhar University Hospitals
Cairo, Egypt
RECRUITINGIntraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping).
Started once renal artery clamped before tumor enucleation till release of the clamp after 1st layer renorraphy in group 1 or Thulium beam coagulation in group 2
Time frame: during the surgery
Suture time and operative time in minutes
Suture time starts from the first suture to the last one, including time of manipulating needles.
Time frame: during the surgery
Intraoperative number of sutures for renorraphy
which is the count of each time the needle comes out from the renal parenchyma.
Time frame: during the surgery
Intraoperative Blood loss
Blood loss will be calculated from the suction jar minus the amount of fluid irrigation
Time frame: during the surgery
Blood transfusion rate
Amount of blood in ml transfused intraoperative or postoperative
Time frame: perioperatively
Renal function: serum creatinine
will be estimated by serum creatinine. Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function
Time frame: 3 months
Renal function: estimated GFR (eGFR)
ill be estimated by estimated GFR (eGFR) using Modification of Diet in Renal Disease (MDRD) equation (Levey et al., 2006). Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function
Time frame: 3 months
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Transforming growth factor beta (TGF-β) urine level
will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN
Time frame: pre-surgery, at 24 hours and at 1 month
Monocyte chemoattractant protein (MCP-1) urine level
will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN
Time frame: pre-surgery, at 24 hours and at 1 month
Hospital stay
from time of surgery till time of patient discharge.
Time frame: perioperatively
Post operative pain
by Visual Analogue Scale The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between "0 or no pain" and "100 or worst pain".
Time frame: perioperatively