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

Renal Cancer Clinical Trial

Official title:

Which is Better to Assess Postoperative Complications in Patients Undergoing Laparoscopic Partial Nephrectomy?: Clavien-Dindo Classification Versus Comprehensive Complication Index.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05823545
• Other study ID #: OMU KAEK 26.12.2019/876
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: March 3, 2021

Study information

• Verified date: April 2023
• Source: Samsun Liv Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 3, 2021
• Est. primary completion date: October 7, 2020
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Cancer

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University, Department of Urology	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Liv Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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 — View Citation

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. — View Citation

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 random — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Opertaion time	From first trocar incision to closure of all incisions	during the surgery (minute)
Primary	Estimeted blood loss	perioperative estimated blood loss	during the surgery (mL)
Primary	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)

External Links

•   Surgical technique