Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors

NCT06969131 | Completed

• 1 other identifier: SVU/MED/URO016/2/22/5/400
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy.

Conditions

Pentafecta; Laparoscopic; Partial Nephrectomy; Renal Tumors

Outcome Measures

Primary Outcomes (1)

• Predictor of pentafecta achievement

  Predictor of pentafecta achievement, such as smoking index, was recorded.

  12 months postoperatively

Secondary Outcomes (7)

• Amount of blood loss

  Intraoperatively

• Surgery duration

  Intraoperatively

• Length of hospital stay

  Till discharge from hospital (Up to one week).

• Intraoperative complications

  Intraoperatively

• Degree of pain

  24 hours postoperatively

Study Arms (2)

Open Partial Nephrectomy

EXPERIMENTAL

Patients underwent open partial nephrectomy.

Procedure: Open Partial Nephrectomy

Laparoscopic Partial Nephrectomy

EXPERIMENTAL

Patients underwent laparoscopic partial nephrectomy.

Procedure: Laparoscopic Partial Nephrectomy

Interventions

Open Partial Nephrectomy PROCEDURE

Patients underwent open partial nephrectomy.

Open Partial Nephrectomy

Laparoscopic Partial Nephrectomy PROCEDURE

Patients underwent laparoscopic partial nephrectomy.

Laparoscopic Partial Nephrectomy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Both sexes.
• Patients who diagnosed with clinical T1 or T2a N0M0 renal tumors who were suitable candidates for partial nephrectomy

You may not qualify if:

• Severe and irreversible coagulopathy.
• Anatomically unfavorable tumor location.
• Extensive encasement of the renal pedicle.
• Diffuse invasion of the renal vein or central collecting system.
• Adjacent organ invasion consistent with stage cT4 disease.
• Regional lymphadenopathy (stage cTxN1), or anticipated retention of less than 20% of total nephron mass.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley university

South Valley, Qena Governorate, 83523, Egypt

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Urology, Faculty of Medicine, South Valley University, Egypt.

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 13, 2025
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)