Skip to main content
OpenTrials
Completed

NCT Number: NCT05498246

Bipolar Coagulation Versus Suture Renorrhaphy in Laparoscopic Partial Nephrectomy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Kadry Mostafa

Banhā, Qalyubia Governorate, 013, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic partial nephrectomy

Procedure

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

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 12, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.