Bipolar Coagulation Versus Suture Renorrhaphy in Laparoscopic Partial Nephrectomy

Study Overview
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Brief Summary
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To compare between bipolar coagulation of tumor bed in laparoscopic partial nephrectomy versus suture renorrhaphy

Detailed Description
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Partial nephrectomy is the standard of care for T1 renal masses (local tumour) it preserves as much normal renal tissue as possible to avoid post-operative acute renal failure, chronic kidney disease and associated metabolic and cardiovascular morbidities . The main challenges that affect partial nephrectomy outcome is the need for renal ischemia to achieve good hemostasis, and the long-term oncological consequences associated with positive surgical margin. Laparoscopic partial nephrectomy has been widely used lately as it is associated with less blood loss, short hospital stay and early recovery in comparison to open partial nephrectomy . Hemostasis of the tumor bed after laparoscopic partial nephrectomy can be achieved by various techniques including Suture renorrhaphy which can be used whatever the bleeding area, the size of bleeding vessel, or the amount of bleeding. However, it consumes more ischemia time, involves functional parenchyma, and requires high laparoscopic skills . There for in our study we tried to find a way to improve the functional and oncological outcome of laparoscopic partial nephrectomy by comparing the bipolar coagulation versus conventional suture renorrhaphy in performing stable hemostasis of tumor bed

Official Title
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Bipolar Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumour Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study

Conditions
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Nephrectomy

Intervention / Treatment
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* Procedure: laparoscopic partial nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiological diagnosis of renal mass less than 7cm Renal mass in patients with chronic kidney disease Exclusion Criteria: Patients with Central or hilar renal masses Renal masses close to pelvi-calyceal system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were divided into two groups by close envelope method in this prospective study. group (A) included 30 cases in which we used bipolar coagulation for hemostasis ,group (B) included 30 cases in which we used suture renorrhaphy.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group (A) included 30 cases in which we used bipolar coagulation for hemostasis<br>group (A) included 30 cases in which we used bipolar coagulation for hemostasis | Procedure: laparoscopic partial nephrectomy<br>* Operations were done under general anesthesia. Patients were positioned in modified lateral kidney position for trans-peritoneal procedures. Pneumoperitoneum using the Veress needle technique and trocar placement . Dissection to the renal hilum for good and sufficient exposure of the renal vessels. Good exposure of the tumor and marking the excision site with electro cautery. Clamping of renal vessels using laparoscopic Bulldog appliers. Excision of the renal mass using visual assessment to determine the suitable depth of normal parenchyma to be excised in order to achieve a negative surgical margin. Unclamping was done and re-assessment of the hemostasis to secure residual bleeding points. Approximation of the edges of renal parenchyma using suturing in both groups. The specimen was placed in an EndoCatch bag and removed through pfannenstiel incisionsurgical drain was placed in the paracolic gutter<br>|
| Active Comparator: group (B) included 30 cases in which we used suture renorrhaphy<br>group (B) included 30 cases in which we used suture renorrhaphy | Procedure: laparoscopic partial nephrectomy<br>* Operations were done under general anesthesia. Patients were positioned in modified lateral kidney position for trans-peritoneal procedures. Pneumoperitoneum using the Veress needle technique and trocar placement . Dissection to the renal hilum for good and sufficient exposure of the renal vessels. Good exposure of the tumor and marking the excision site with electro cautery. Clamping of renal vessels using laparoscopic Bulldog appliers. Excision of the renal mass using visual assessment to determine the suitable depth of normal parenchyma to be excised in order to achieve a negative surgical margin. Unclamping was done and re-assessment of the hemostasis to secure residual bleeding points. Approximation of the edges of renal parenchyma using suturing in both groups. The specimen was placed in an EndoCatch bag and removed through pfannenstiel incisionsurgical drain was placed in the paracolic gutter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare between bipolar coagulation of tumor bed in laparoscopic partial nephrectomy versus suture renorrhaphy | patients were assessed preoperative by weight in kg and height in meters weight and height will be combined to report body mass index in kg/m^2 ,base line creatinine in mil gm ,baseline hemoglobin in gm,leterality ,CT to examine size in cm and RENAL score and asses patients intra operative by operative time in minutes ,ischemic time in minutes ,estimated blood loss in gm and hospital stay in days | baseline frame |