Renal Malignant Tumor, Renal Tumor
Conditions
Keywords
Thulium laser, Laparoscopic partial nephrectomy, Ischemia time, Small renal mass
Brief summary
To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.
Detailed description
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.
Interventions
PROCEDURESuture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy
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.
PROCEDUREThulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy
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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized prospective comparative study. Two-arm parallel assignment: First Arm: involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed. Second Arm: involves cases of laparoscopic partial nephrectomy using thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* cT1 single renal mass.
Exclusion criteria
1. Absolute contraindication for laparoscopic surgery (e.g., severe cardiopulmonary insufficiency, and chronic obstructive lung disease). 2. Renal mass involving the hilum. 3. Renal mass in patients with chronic kidney disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocyte chemoattractant protein (MCP-1) urine level | pre-surgery, at 24 hours and at 1 month | will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN |
| Renal function: estimated GFR (eGFR) | 3 months | 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 |
| Transforming growth factor beta (TGF-β) urine level | pre-surgery, at 24 hours and at 1 month | will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN |
| Intraoperative Blood loss | during the surgery | Blood loss will be calculated from the suction jar minus the amount of fluid irrigation |
| Blood transfusion rate | perioperatively | Amount of blood in ml transfused intraoperative or postoperative |
| Intraoperative number of sutures for renorraphy | during the surgery | which is the count of each time the needle comes out from the renal parenchyma. |
| Suture time and operative time in minutes | during the surgery | Suture time starts from the first suture to the last one, including time of manipulating needles. |
| Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping). | during the surgery | 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 |
| Renal function: serum creatinine | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain | perioperatively | 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. |
| Hospital stay | perioperatively | from time of surgery till time of patient discharge. |
Countries
Egypt
Contacts
Primary ContactEhab Atallah, A. Lecturer
Backup ContactHesham AboZied, Professor
Outcome results
None listed