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

NCT06424080 | Recruiting

• 1 other identifier: 6-2024UROL12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• compare between laparoscopic and robotic partial nephrectomy pathological safty margin

  1 year

Study Arms (2)

laparoscopic partial nephrectomy

OTHER

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

Procedure: laparoscopic partial nephrectomy

robotic partial nephrectomy

OTHER

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

Procedure: robotic partial nephrectomy

Interventions

laparoscopic partial nephrectomy PROCEDURE

cases amenable for partial nephrectomy

laparoscopic partial nephrectomy

robotic partial nephrectomy PROCEDURE

cases amenable for partial nephrectomy

robotic partial nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• any unfit pt for partial nephrectomy
• more than 7cm tumor
• mass not amenable for partial nephrectomy
• metastatic tumor or locally advanced

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Hossam Kandeel

Shibīn al Kawm, Menoufia -, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• hossam elsayed kandeel, MSC

  Director

  STUDY DIRECTOR

Central Study Contacts

hossam elsayed kandeel, MSC

CONTACT

01097991198; hossamkandeel016@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yassin Abdelghaffar st-from Gamal Abdel Nasar st- faculty of medicine

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 21, 2024
• Study Start: May 1, 2024
• Primary Completion: November 10, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

EG (1)