Peptic Ulcer Perforation Study

Peptic Ulcer Perforation Clinical Trial

— PULP  

Official title:

Peptic Ulcer Perforation Study - an Optimized Perioperative Course for Patients Surgically Treated for Peptic Ulcer Perforation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624169
• Other study ID #: H-D-2007-0044
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: May 26, 2010
• Start date: November 2007
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to implement an optimized perioperative course for patients surgically treated for peptic ulcer perforation in order to improve the outcome for these patients.

The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients surgically treated for benign peptic ulcer perforation

Exclusion Criteria:

• Age < 18 years

• Pregnant and breastfeeding women

• Malign ulcer perforation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Perforation
• Ulcer

Intervention

Procedure:
• An optimized perioperative course
A number of interventions before, during and after surgery

Locations

Country	Name	City	State
Denmark	Århus University Hospital	Århus
Denmark	Copenhagen University Hospital Bispebjerg	Copenhagen NV
Denmark	Copenhagen University Hospital Helsingør	Helsingor
Denmark	Copenhagen University Hospital Herlev	Herlev
Denmark	Copenhagen University Hospital Hillerød	Hillerød
Denmark	Copenhagen University Hospital Hvidovre	Hvidovre
Denmark	Odense University Hospital	Odense

Sponsors (7)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Aarhus University Hospital, Bispebjerg Hospital, Helsingør hospital, Hillerod Hospital, Denmark, Hvidovre University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality rate		Within 30 days of surgery	No