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

Sponsor

Samsun Liv Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05823545

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Renal Cancer Surgery-Complications

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

Actual Enrollment :

62 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Oct 7, 2020

Actual Study Completion Date :

Mar 3, 2021

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ondokuz Mayıs University, Department of Urology	Samsun		Turkey	55020

Sponsors and Collaborators

Samsun Liv Hospital

Investigators

Study Chair: Ender Ozden, Prof., Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
Principal Investigator: Mehmet N Mercimek, Assoc. Prof., Atasam Hospital, Departmen of Urology, Samsun, Turkey