Bipolar Coagulation Versus Suture Renorrhaphy in Laparoscopic Partial Nephrectomy

Not Applicable

Completed

• Conditions: Nephrectomy
• Interventions: Procedure: laparoscopic partial nephrectomy

• Registration Number: NCT05498246
• Lead Sponsor: Benha University

Brief Summary

To compare between bipolar coagulation of tumor bed in laparoscopic partial nephrectomy versus suture renorrhaphy

Detailed Description

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

Study Timeline

• Study Start: 2020-12-05
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-25
• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-12
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Radiological diagnosis of renal mass less than 7cm
• Renal mass in patients with chronic kidney disease

Read More

Exclusion Criteria

• Patients with Central or hilar renal masses
• Renal masses close to pelvi-calyceal system

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (A) included 30 cases in which we used bipolar coagulation for hemostasis	laparoscopic partial nephrectomy	group (A) included 30 cases in which we used bipolar coagulation for hemostasis
group (B) included 30 cases in which we used suture renorrhaphy	laparoscopic partial nephrectomy	group (B) included 30 cases in which we used suture renorrhaphy

Primary Outcome Measures

Name	Time	Method
To compare between bipolar coagulation of tumor bed in laparoscopic partial nephrectomy versus suture renorrhaphy	baseline frame	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

Trial Locations

Locations (1)

Mohamed Kadry Mostafa; 🇪🇬 Banhā, Qalubia, Egypt