NCT05823545

Brief Summary

This study aims to compare the strength of the classical Clavien-Dindo classification system (CDC), which is a Likert scale analysis versus the comprehensive complication index (CCI), a new quantitative evaluation system, in patients undergoing laparoscopic partial nephrectomy (LPN).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

April 10, 2023

Last Update Submit

April 21, 2023

Conditions

Renal CancerSurgery-Complications

Keywords

laparoscopypartial nephrectomycomplicationCCIurology

Outcome Measures

Primary Outcomes (4)

  • Postoperative complication

    Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up

    up to 3 months, postoperatively

  • Opertaion time

    From first trocar incision to closure of all incisions

    during the surgery (minute)

  • Estimeted blood loss

    perioperative estimated blood loss

    during the surgery (mL)

  • warm ischemia time

    Its starts when the renal artery and vein are controlled and it ends when reperfusion of the graft kidney starts on the back table

    during the surgery (minute)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A retrospective analysis was carried out on 517 surgical procedures in 503 patients who underwent LPN between November 2009 and August 2020 in a tertiary university hospital. Sixty-two patients with postoperative complications were included in the study.

You may qualify if:

  • patients with complete data
  • patients with consent
  • Patients \> 18 year-old
  • The surgeries performed by the surgeon EO

You may not qualify if:

  • Missing data
  • patients without consent
  • patients who underwent open or retroperitoneoscopic laparoscopic partial nephrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University, Department of Urology

Samsun, 55020, Turkey (Türkiye)

Location

Related Publications (3)

  • Loffel LM, Gross T, Schneider MP, Burkhard FC, Thalmann GN, Bosshard P, Wuethrich PY, Furrer MA. Complication reporting with the Bern Comprehensive Complication Index CCI after open radical prostatectomy: A longitudinal long-term single-center study. Urol Oncol. 2020 Mar;38(3):79.e1-79.e8. doi: 10.1016/j.urolonc.2019.09.021. Epub 2019 Dec 31.

    PMID: 31899103BACKGROUND

  • Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.

    PMID: 25379846RESULT

  • Kim TH, Suh YS, Huh YJ, Son YG, Park JH, Yang JY, Kong SH, Ahn HS, Lee HJ, Slankamenac K, Clavien PA, Yang HK. The comprehensive complication index (CCI) is a more sensitive complication index than the conventional Clavien-Dindo classification in radical gastric cancer surgery. Gastric Cancer. 2018 Jan;21(1):171-181. doi: 10.1007/s10120-017-0728-3. Epub 2017 Jun 8.

    PMID: 28597328RESULT

Related Links

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Ender Ozden, Prof.

    Ondokuz Mayıs University, Faculty of Medicine, Department of Urology

    STUDY CHAIR

  • Mehmet N Mercimek, Assoc. Prof.

    Atasam Hospital, Departmen of Urology, Samsun, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, FEBU

Study Record Dates

First Submitted

April 10, 2023

First Posted

April 21, 2023

Study Start

February 1, 2020

Primary Completion

October 7, 2020

Study Completion

March 3, 2021

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)