跳至主要内容
临床试验/NCT05823545
NCT05823545已完成不适用

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

Samsun Liv Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Opertaion time

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Opertaion time

时间窗: during the surgery (minute)

From first trocar incision to closure of all incisions

Estimeted blood loss

时间窗: during the surgery (mL)

perioperative estimated blood loss

warm ischemia time

时间窗: 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

时间窗: up to 3 months, postoperatively

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

次要结局

未报告次要终点

研究者

发起方
Samsun Liv Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet N. Mercimek, MD, FEBU

Associate professor, MD, FEBU

Samsun Liv Hospital

研究点 (1)

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