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Trial Title:
Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.
NCT ID:
NCT06424080
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopic partial nephrectomy
Description:
cases amenable for partial nephrectomy
Arm group label:
laparoscopic partial nephrectomy
Intervention type:
Procedure
Intervention name:
robotic partial nephrectomy
Description:
cases amenable for partial nephrectomy
Arm group label:
robotic partial nephrectomy
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hossam Kandeel
Address:
City:
Shibīn Al Kawm
Zip:
12345
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
hossam elsayed kandeel, MSC
Phone:
01097991198
Phone ext:
002
Email:
hossamkandeel016@gmail.com
Start date:
May 1, 2024
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Menoufia University
Agency class:
Other
Source:
Menoufia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06424080
