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

Completed

• Conditions: Renal Cancer; Surgery-Complications

• Registration Number: NCT05823545
• Lead Sponsor: Samsun Liv Hospital

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-10-07
• Study Completion: 2021-03-03
• Status Verified: 2023-04
• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-21
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Opertaion time	during the surgery (minute)	From first trocar incision to closure of all incisions
Estimeted blood loss	during the surgery (mL)	perioperative estimated blood loss
warm ischemia time	during the surgery (minute)	Its starts when the renal artery and vein are controlled and it ends when reperfusion of the graft kidney starts on the back table
Postoperative complication	up to 3 months, postoperatively	Abnormal clinical and laboratory findings that may be seen after surgery and require additional intervention, treatment, or follow-up

Trial Locations

Locations (1)

Ondokuz Mayıs University, Department of Urology; 🇹🇷 Samsun, Turkey