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

NCT ID: NCT06424080

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic partial nephrectomy

cases of renal cell carcinoma , localized tumors , candidate for laparoscopic partial nephrectomy

Group Type OTHER

laparoscopic partial nephrectomy

Intervention Type PROCEDURE

cases amenable for partial nephrectomy

robotic partial nephrectomy

cases of renal cell carcinoma , localized tumors , candidate for robotic partial nephrectomy

Group Type OTHER

robotic partial nephrectomy

Intervention Type PROCEDURE

cases amenable for partial nephrectomy

Interventions

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laparoscopic partial nephrectomy

cases amenable for partial nephrectomy

Intervention Type PROCEDURE

robotic partial nephrectomy

cases amenable for partial nephrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Hossam Kandeel

Yassin Abdelghaffar st-from Gamal Abdel Nasar st- faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hossam elsayed kandeel, MSC

Role: STUDY_DIRECTOR

Director

Locations

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Hossam Kandeel

Shibīn al Kawm, Menoufia -, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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hossam elsayed kandeel, MSC

Role: CONTACT

01097991198 ext. 002

Facility Contacts

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hossam elsayed kandeel, MSC

Role: primary

01097991198 ext. 002

Other Identifiers

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6-2024UROL12

Identifier Type: -

Identifier Source: org_study_id

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