Clinical trial NCT05823545: Assessment of Complications in Patients Who Underwent LPN According to the CCI
Official title: Which is Better to Assess Postoperative Complications in Patients Undergoing Laparoscopic Partial Nephrectomy?: Clavien-Dindo Classification Versus Comprehensive Complication Index.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cancer
Surgery-Complications
Keywords: laparoscopy
partial nephrectomy
complication
CCI
urology
Lead sponsor: Samsun Liv Hospital
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_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.

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.

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

Primary outcomes:
measure: Postoperative complication
timeFrame: up to 3 months, postoperatively
measure: Opertaion time
timeFrame: during the surgery (minute)
measure: Estimeted blood loss
timeFrame: during the surgery (mL)
measure: warm ischemia time
timeFrame: during the surgery (minute)
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University, Department of Urology
Study officials:
affiliation: Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
name: Ender Ozden, Prof.
role: STUDY_CHAIR
affiliation: Atasam Hospital, Departmen of Urology, Samsun, Turkey
name: Mehmet N Mercimek, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.
citation: 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.