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Completed

NCT Number: NCT05823545

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

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).

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Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Surgery-Complications Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayıs University, Department of Urology

Samsun, 55020, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative complication

    Time frame: up to 3 months, postoperatively

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

  2. Opertaion time

    Time frame: during the surgery (minute)

    From first trocar incision to closure of all incisions

  3. Estimeted blood loss

    Time frame: during the surgery (mL)

    perioperative estimated blood loss

  4. warm ischemia time

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsun Liv Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 21, 2023
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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