Post Surgically Treated Peritonitis Complications | NCT03284476

Studies
Post Surgically Treated Peritonitis Complications

NCT03284476

Sponsor

Nantes University Hospital

Status

Withdrawn

Last Update Posted

Jun 4, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Peritonitis

Interventions

Collection of medical data from ICU patients

Countries

France

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No inclusion

Expanded Access Info

Start Date

Apr 2013Estimated

Primary Completion Date

Jun 2020Actual

Completion Date

Jun 2020Actual

First Submitted Date

Sep 14, 2017

First Submission Date that Met QC Criteria

Sep 14, 2017

First Posted Date

Sep 15, 2017Actual

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

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this observational study is to investigate the management and the complications associated wtih surgically treated peritonitis.

Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed Description

Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICU patients		Collection of medical data of Patients with peritonitis (nosocomial or community-acquired) or Patients with post-operative peritonitis	Other: Collection of medical data from ICU patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collection of medical data from ICU patients	Other	Medical data collected on a electronic secured data base	ICU patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In ICU stay main complications	Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors)	Within the first 28 days after ICU admission date

Secondary Outcomes

Measure	Description	Time Frame
Duration of mechanical ventilation		In ICU (up to 90 days)
ICU length of stay		In ICU (up to 90 days)

Other Outcomes

Measure	Description	Time Frame
Death		In ICU (up to 90 days)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nosocomial surgically treated Peritonitis
Or Community-Acquired surgically treated Peritonitis
Or Post-operative surgically treated Peritonitis

Exclusion Criteria:

Consent withdrawal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients hospitalized in ICU for peritonitis surgically treated

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karim Asehnoune, MD, PhD	Non Affiliated	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angers University Hospital		Angers		49000	France
Nantes University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010538	Peritonitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D010532	Peritoneal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided