Acute Appendicitis in Foreign Workers of Northern Israel | NCT04895163

Studies
Acute Appendicitis in Foreign Workers of Northern Israel

NCT04895163

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

May 21, 2021Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Surgery

Interventions

Laparoscopic appendectomy

Countries

Israel

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

May 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

Jan 1, 2018Actual

Primary Completion Date

Apr 28, 2021Actual

Completion Date

Apr 28, 2021Actual

First Submitted Date

May 17, 2021

First Submission Date that Met QC Criteria

May 17, 2021

First Posted Date

May 20, 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

May 19, 2021

Last Update Posted Date

May 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Uri Kaplan , MD, Acting head of bariatri center, Head of GEJ surgical unit, HaEmek Medical Center, IsraelPrincipal Investigator

Lead Sponsor

HaEmek Medical Center, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To Compare the outcome to acute appendicitis in foreign workers to the native patients.

Detailed Description

This is a retrospective case-control study. The investigators identified all patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis. The study group included all foreign workers and the control group was age, sex, and co-morbidities matched group from the local population. The investigators compared time to presentation, admission parameters and disease outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Foreign workers		Foreign workers aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis.	Procedure: Laparoscopic appendectomy
Local patients		Local patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis.	Procedure: Laparoscopic appendectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic appendectomy	Procedure	Laparoscopic appendectomy performed for acute appendicitis	Foreign workers Local patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of complicated disease	amount of cases defined as complicated acute appendicitis	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis

Exclusion Criteria:

Pregnant women
Patient whose pathology report of the appendix was normal

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided