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Clinical Trials/NCT05823545
NCT05823545
Completed
Not Applicable

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

Samsun Liv Hospital1 site in 1 country62 target enrollmentStarted: February 1, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Samsun Liv Hospital
Enrollment
62
Locations
1
Primary Endpoint
Opertaion time

Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Opertaion time

Time Frame: during the surgery (minute)

From first trocar incision to closure of all incisions

Estimeted blood loss

Time Frame: during the surgery (mL)

perioperative estimated blood loss

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Samsun Liv Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet N. Mercimek, MD, FEBU

Associate professor, MD, FEBU

Samsun Liv Hospital

Study Sites (1)

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