## Protocol Section
### Identification Module
**NCT ID:** NCT06424080

**Brief Title:** Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.

**Official Title:** Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.

#### Organization Study ID Info
**ID:** 6-2024UROL
#### Organization
**Class:** OTHER
**Full Name:** Menoufia University
### Status Module
#### Completion Date
**Date:** 2025-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-11-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Menoufia University

#### Responsible Party

**Investigator Affiliation:** Menoufia University

**Investigator Full Name:** Hossam Kandeel

**Investigator Title:** Yassin Abdelghaffar st-from Gamal Abdel Nasar st- faculty of medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Renal Cell Carcinoma

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: laparoscopic partial nephrectomy

**Label:** laparoscopic partial nephrectomy

**Type:** OTHER

#### Arm Group 2

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

**Intervention Names:**

- Procedure: robotic partial nephrectomy

**Label:** robotic partial nephrectomy

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- laparoscopic partial nephrectomy

**Description:** cases amenable for partial nephrectomy

**Name:** laparoscopic partial nephrectomy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- robotic partial nephrectomy

**Description:** cases amenable for partial nephrectomy

**Name:** robotic partial nephrectomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** to compare between laparoscopic and robotic partial nephrectomy regards ischemia time

**Measure:** to compare between laparoscopic and robotic partial nephrectomy regards ischemia time

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** compare between laparoscopic and robotic partial nephrectomy pathological safty margin

**Measure:** compare between laparoscopic and robotic partial nephrectomy pathological safty margin

**Time Frame:** 1 year

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hossamkandeel016@gmail.com

**Name:** hossam elsayed kandeel, MSC

**Phone:** 01097991198

**Phone Ext:** 002

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shibīn Al Kawm

**Contacts:**

***Contact 1:***

- **Email:** hossamkandeel016@gmail.com

- **Name:** hossam elsayed kandeel, MSC

- **Phone:** 01097991198

- **Phone Ext:** 002

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Hossam Kandeel

**State:** Menoufia -

**Status:** RECRUITING

**Zip:** 12345

#### Overall Officials

**Official 1:**

**Affiliation:** Director

**Name:** hossam elsayed kandeel, MSC

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000007680

- Term: Kidney Neoplasms

- ID: D000014571

- Term: Urologic Neoplasms

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5548

- Name: Carcinoma, Renal Cell

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

- ID: M10703

- Name: Kidney Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M17320

- Name: Urologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4906

- Name: Renal Cell Carcinoma

- Relevance: HIGH

- As Found: Renal Cell Carcinoma

- ID: T1341

- Name: Clear Cell Renal Cell Carcinoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002292

- Term: Carcinoma, Renal Cell

### Misc Info Module

- Version Holder: 2024-05-31
