Comparison of the Clavien-Dindo and Comprehensive Complic... | NCT04849702

Studies
Comparison of the Clavien-Dindo and Comprehensive Complication Index

NCT04849702

Sponsor

Jessa Hospital

Status

Completed

Last Update Posted

Apr 19, 2021Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Complication of Surgical Procedure
Colorectal Disorders
Clavien Dindo
Comprehensive Complication Index

Interventions

No intervention was compared

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2012Actual

Primary Completion Date

Sep 20, 2013Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

Apr 2, 2021

First Submission Date that Met QC Criteria

Apr 15, 2021

First Posted Date

Apr 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2021

Last Update Posted Date

Apr 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our aim was to compare 2 postoperative complication scoring systems in predicting length of hospital stay and in-hospital costs after colorectal resections.

Detailed Description

Introduction: Postoperative complications are associated with prolonged hospital stay and rise in costs of treatment. The Comprehensive Complication Index (CCI) was developed as a scoring system that does not only take the most severe complication into account, but all complications after surgery. Our aim was to compare the Clavien-Dindo scoring system with the CCI in predicting length of hospital stay (LOHS) and in-hospital costs after colorectal resections.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Postoperative complication after colorectal resection		Documentation of all postoperative complications after colorectal resections	Procedure: No intervention was compared

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention was compared	Procedure	No intervention was compared	Postoperative complication after colorectal resection

Measure	Description	Time Frame
Length of hospital stay		1 year
Total in-hospital costs		1 year

Measure	Description	Time Frame
Length of ICU stay		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Only patients that underwent a colorectal resection were included

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Data of patients in which complications occurring after surgical procedures, performed between October 2012 and September 2013, were recorded.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karel MC Smeyers, MD	Jessa hospital, Hasselt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jessa Hospital		Hasselt	Limburg	3500	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided