Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.

Renal Cell Carcinoma Clinical Trial

Official title:

Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06424080
• Other study ID #: 6-2024UROL12
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2024
• Source: Menoufia University
• Contact: hossam elsayed kandeel, MSC
• Phone: 01097991198
• Email: hossamkandeel016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.

As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .

The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.

Moreover, robotic assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) seems to be significantly better than OPN in terms of perioperative complications, estimated blood loss and hospital stay. Conversely, transfusion rate, ischemia time, change in estimated glomerular filtration rate and early cancer outcomes are similar between the two approaches. International guidelines recommend the use of both approaches according to the surgeon and patient preferences.

so, we are plaining to do the study comparing between RAPN and LPN regarding feasibility and ability of both techniques.

Description:

Renal cell carcinoma (RCC) represents a significant burden of malignancy. Over the past 2-3 decades, the incidence of kidney cancer has steadily increased all around the world ,.The EUA Guidelines suggested that surgery is the only curative treatment for localized renal cell carcinoma.

Surgical treatment of RCC either radical or partial nephrectomy is related to the clinical stage of the disease and to the general condition of the patient. Modern medical imaging has further revolutionized the role of PN due to the increasing volume of incidentally diagnosed small renal masses.

Indeed, partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.

As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .

The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.

Moreover, robotic assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) seems to be significantly better than OPN in terms of perioperative complications, estimated blood loss and hospital stay. Conversely, transfusion rate, ischemia time, change in estimated glomerular filtration rate and early cancer outcomes are similar between the two approaches. International guidelines recommend the use of both approaches according to the surgeon and patient preferences.

so, we are plaining to do the study comparing between RAPN and LPN regarding feasibility and ability of both techniques.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: November 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• renal mass T1 according to TNM amenable for partial nephrectomy.

Exclusion Criteria:

• any unfit pt for partial nephrectomy

• more than 7cm tumor

• mass not amenable for partial nephrectomy

• metastatic tumor or locally advanced

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• laparoscopic partial nephrectomy
cases amenable for partial nephrectomy
• robotic partial nephrectomy
cases amenable for partial nephrectomy

Locations

Country	Name	City	State
Egypt	Hossam Kandeel	Shibin Al Kawm	Menoufia -

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to compare between laparoscopic and robotic partial nephrectomy regards ischemia time	to compare between laparoscopic and robotic partial nephrectomy regards ischemia time	1 year
Secondary	compare between laparoscopic and robotic partial nephrectomy pathological safty margin	compare between laparoscopic and robotic partial nephrectomy pathological safty margin	1 year