LPN in Patients With High-complex Renal Tumors

NCT ID: NCT04933604

Last Updated: 2021-06-22

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

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-02-04

Brief Summary

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The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.

Detailed Description

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From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.

Conditions

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Renal Cancer Renal Neoplasm Renal Cell Carcinoma Surgery Oncology Kidney Ischemia Kidney Injury Urologic Neoplasms Urologic Cancer Kidney Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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LPN group

39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy

laparoscopic partial nephrectomy

Intervention Type PROCEDURE

Nephron sparing minimally invasive surgery

LRN group

39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy

Laparoscopic radical nephrectomy

Intervention Type PROCEDURE

Completely removal of kidney by using laparoscopic surgery

Interventions

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laparoscopic partial nephrectomy

Nephron sparing minimally invasive surgery

Intervention Type PROCEDURE

Laparoscopic radical nephrectomy

Completely removal of kidney by using laparoscopic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with complete data
* Patients with single renal tumor on the effected side
* Patients who approved the written consent form

Exclusion Criteria

* Patients who not approved the written consent form
* Patients with incomplete data
* Patients with low or mild complexity renal tumors
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role collaborator

Samsun Liv Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Necmettin Mercimek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ender Ozden, Prof.

Role: STUDY_DIRECTOR

Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalı

Saban Sarıkaya, Prof.

Role: STUDY_CHAIR

Ondokuz Mayıs University, Faculty of Medicine, Department of Urology

Mehmet Mercimek, MD, FEBU

Role: PRINCIPAL_INVESTIGATOR

Liv Hospital Samsun, Department of Urology

Yakup Bostancı, Prof.

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University, Faculty of Medicine, Department of Urology

Murat Gulsen, MD

Role: PRINCIPAL_INVESTIGATOR

Samsun Gazi State Hospital, Departmen of Urology, Samsun, Turkey

Locations

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Ondokuz Mayıs University, Department of Urology

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.

Reference Type RESULT
PMID: 27988238 (View on PubMed)

Mir MC, Derweesh I, Porpiglia F, Zargar H, Mottrie A, Autorino R. Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies. Eur Urol. 2017 Apr;71(4):606-617. doi: 10.1016/j.eururo.2016.08.060. Epub 2016 Sep 7.

Reference Type RESULT
PMID: 27614693 (View on PubMed)

Yang F, Zhou Q, Xing N. Comparison of survival and renal function between partial and radical laparoscopic nephrectomy for T1b renal cell carcinoma. J Cancer Res Clin Oncol. 2020 Jan;146(1):261-272. doi: 10.1007/s00432-019-03058-z. Epub 2019 Nov 1.

Reference Type RESULT
PMID: 31677114 (View on PubMed)

Other Identifiers

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OMU KAEK 11.07.2019/538

Identifier Type: -

Identifier Source: org_study_id

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