LPN in Patients With High-complex Renal Tumors

June 13, 2021 updated by: Mehmet Necmettin Mercimek, Samsun Liv Hospital

Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55020
        • Ondokuz Mayıs University, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LPN group
39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy
Procedure: laparoscopic partial nephrectomy
Nephron sparing minimally invasive surgery
LRN group
39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy
Procedure: Laparoscopic radical nephrectomy
Completely removal of kidney by using laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: at the end of the surgery
time from onset to complete of surgery
at the end of the surgery
Blood loss
Time Frame: at the end of the surgery
amount of bleeding during surgery (mL)
at the end of the surgery
warm ischemia time
Time Frame: at the and of the surgery
The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy
at the and of the surgery
Postoperative complication
Time Frame: up to 3 months postoperatively
abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
up to 3 months postoperatively
functional outcomes
Time Frame: 1 year after the surgery
serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
1 year after the surgery
surigcal margin status
Time Frame: postoperative follow-up, through study completion, an average of 1 year
presence or absence of tumors at the surgical margin
postoperative follow-up, through study completion, an average of 1 year
CKD stage upgrading
Time Frame: postoperative follow-up, through study completion, an average of 1 year
evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
postoperative follow-up, through study completion, an average of 1 year
Oncological outomes
Time Frame: postoperative follow-up, through study completion, an average of 1 year
Presence or absence of local and/or distal tumor recurrence
postoperative follow-up, through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun Liv Hospital

Collaborators

Ondokuz Mayıs University

Investigators

  • Study Director: Ender Ozden, Prof., Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalı
  • Study Chair: Saban Sarıkaya, Prof., Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
  • Principal Investigator: Mehmet Mercimek, MD, FEBU, Liv Hospital Samsun, Department of Urology
  • Principal Investigator: Yakup Bostancı, Prof., Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
  • Principal Investigator: Murat Gulsen, MD, Samsun Gazi State Hospital, Departmen of Urology, Samsun, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 13, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 13, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMU KAEK 11.07.2019/538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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