Assessment of Complications in Patients Who Underwent LPN According to the CCI

NCT ID: NCT05823545

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-03-03

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).

Detailed Description

Prospectively collected data of sixty-two patients undergoing LPN with postoperative complications from November 2009 to August 2020 were evaluated retrospectively. Postoperative complications were classified according to the CDCs and calculated using the CCI calculator (https://www.assessurgery.com) quantitatively. Major complications were determined as ≥ grade 3 complications according to the CDC. The complexity of the renal mass was defined according to the RENAL nephrometry score. The cut-off value for CCI was analyzed by the ROC analysis technique. The significance level was taken as p<0.05.

Conditions

Renal Cancer; Surgery-Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun Liv Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mehmet N. Mercimek, MD, FEBU

Associate professor, MD, FEBU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ender Ozden, Prof.

Role: STUDY_CHAIR

Ondokuz Mayıs University, Faculty of Medicine, Department of Urology

Mehmet N Mercimek, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Atasam Hospital, Departmen of Urology, Samsun, Turkey

Locations

Ondokuz Mayıs University, Department of Urology

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31899103 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25379846 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28597328 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/32967451/

Surgical technique

Other Identifiers

OMU KAEK 26.12.2019/876

Identifier Type: -

Identifier Source: org_study_id