Development and Validation of a Morbidity Index for Compl... | NCT00782704

Studies
Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery

NCT00782704

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Feb 10, 2015Estimated

Enrollment

219Actual

Phase

Not provided

Conditions

Postoperative Complications

Interventions

Not provided

Countries

Switzerland

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

Feb 2015

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 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Oct 29, 2008

First Submission Date that Met QC Criteria

Oct 29, 2008

First Posted Date

Oct 31, 2008Estimated

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

Feb 9, 2015

Last Update Posted Date

Feb 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim is to develop and validate a morbidity index for postoperative complications in patients undergoing visceral surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

219Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		questionnair for Patients
2		questionnaire for Nurses
3		questionnaire for Physicians

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to develop and validate a morbidity index		preoeprativ and one day before discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: ≥ 18 years
Capacity to act and no legal guardian
Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery
German language as daily language.

Exclusion Criteria:

Patients with cognitive difficulties and diseases, which may yield unreliable answers
Patients unable to read and write

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients: all patients of the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich Nurses: Staff nurses of the University Hospital of Zurich Physicians: from different units of the University Hospital of Zurich (Visceral-, Thoracic, Cardiovascular Surgery, Anesthesiology, Intensiv Care Unit, Urology)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ksenija Slankamenac, med. pract	Department of Visceral and Transplantation Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Visceral and Transplantation Surgery of the University Hospital of Zurich		Zurich	Canton of Zurich	8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided