Bipolar Coagulation Versus Suture Renorrhaphy in Laparoscopic Partial Nephrectomy

Nephrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498246
• Other study ID #: Lap in partial nephrectomy
• Status: Completed
• Phase: N/A
• Start date: December 5, 2020
• Est. completion date: December 25, 2021

Study information

• Verified date: August 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 25, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrectomy

Intervention

Procedure:
• laparoscopic partial nephrectomy
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

Locations

Country	Name	City	State
Egypt	Mohamed Kadry Mostafa	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (17)

Aron M, Gill IS. Minimally invasive nephron-sparing surgery (MINSS) for renal tumours part I: laparoscopic partial nephrectomy. Eur Urol. 2007 Feb;51(2):337-46; discussion 46-7. Epub 2006 Oct 20. Review. — View Citation

Campbell SC, Novick AC, Belldegrun A, Blute ML, Chow GK, Derweesh IH, Faraday MM, Kaouk JH, Leveillee RJ, Matin SF, Russo P, Uzzo RG; Practice Guidelines Committee of the American Urological Association. Guideline for management of the clinical T1 renal m — View Citation

Desai MM, Gill IS, Ramani AP, Spaliviero M, Rybicki L, Kaouk JH. The impact of warm ischaemia on renal function after laparoscopic partial nephrectomy. BJU Int. 2005 Feb;95(3):377-83. — View Citation

García-Segui A, Bercowsky E, Gascón-Mir M. [Simplified renorrhaphy using self-retaining barbed suture during laparoscopic partial nephrectomy]. Actas Urol Esp. 2012 Sep;36(8):497-502. Epub 2012 Jul 20. Spanish. — View Citation

Harbin, A. C, Giusto, L, Lee, V. S., Nadhan, K., Mooney, J., & Eun, D. D. The Use of Argon Beam Coagulation During Robotic Partial Nephrectomy in an Animal Model. Videourology. (2015).

Harmon WJ, Kavoussi LR, Bishoff JT. Laparoscopic nephron-sparing surgery for solid renal masses using the ultrasonic shears. Urology. 2000 Nov 1;56(5):754-9. — View Citation

Kim DK, Kim LH, Raheem AA, Shin TY, Alabdulaali I, Yoon YE, Han WK, Rha KH. Comparison of Trifecta and Pentafecta Outcomes between T1a and T1b Renal Masses following Robot-Assisted Partial Nephrectomy (RAPN) with Minimum One Year Follow Up: Can RAPN for T — View Citation

Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17. — View Citation

Marszalek M, Chromecki T, Al-Ali BM, Meixl H, Madersbacher S, Jeschke K, Pummer K, Zigeuner R. Laparoscopic partial nephrectomy: a matched-pair comparison of the transperitoneal versus the retroperitoneal approach. Urology. 2011 Jan;77(1):109-13. doi: 10. — View Citation

Moinzadeh A, Gill IS, Rubenstein M, Ukimura O, Aron M, Spaliviero M, Nahen K, Finelli A, Magi-Galluzzi C, Desai M, Kaouk J, Ulchaker JC. Potassium-titanyl-phosphate laser laparoscopic partial nephrectomy without hilar clamping in the survival calf model. — View Citation

Msezane LP, Katz MH, Gofrit ON, Shalhav AL, Zorn KC. Hemostatic agents and instruments in laparoscopic renal surgery. J Endourol. 2008 Mar;22(3):403-8. doi: 10.1089/end.2007.9844. Review. — View Citation

Ota T, Komori H, Rii J, Ochi A, Suzuki K, Shiga N, Nishiyama H. Soft coagulation in partial nephrectomy without renorrhaphy: feasibility of a new technique and early outcomes. Int J Urol. 2014 Mar;21(3):244-7. doi: 10.1111/iju.12276. Epub 2013 Sep 18. — View Citation

Ramani AP, Desai MM, Steinberg AP, Ng CS, Abreu SC, Kaouk JH, Finelli A, Novick AC, Gill IS. Complications of laparoscopic partial nephrectomy in 200 cases. J Urol. 2005 Jan;173(1):42-7. — View Citation

Takagi T, Kondo T, Omae K, Iizuka J, Kobayashi H, Yoshida K, Hashimoto Y, Tanabe K. Assessment of Surgical Outcomes of the Non-renorrhaphy Technique in Open Partial Nephrectomy for =T1b Renal Tumors. Urology. 2015 Sep;86(3):529-33. doi: 10.1016/j.urology. — View Citation

Williams SB, Kacker R, Alemozaffar M, Francisco IS, Mechaber J, Wagner AA. Robotic partial nephrectomy versus laparoscopic partial nephrectomy: a single laparoscopic trained surgeon's experience in the development of a robotic partial nephrectomy program. — View Citation

Zhang C, Xu Y, Zhang Z, Qiao B, Yang K, Liu R, Ma B. Laparoscopic simple enucleation and coagulation on tumor bed using argon beam coagulator for treating small renal cell carcinomas: an animal study followed by clinical application. Med Sci Monit. 2012 M — View Citation

Zhao PT, Richstone L, Kavoussi LR. Laparoscopic partial nephrectomy. Int J Surg. 2016 Dec;36(Pt C):548-553. doi: 10.1016/j.ijsu.2016.04.028. Epub 2016 Apr 21. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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