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Peptic Ulcer Perforation Study (PULP)

This study has been completed.
Sponsor:
Collaborators:
Odense University Hospital
Bispebjerg Hospital
Hvidovre University Hospital
Aarhus University Hospital
Hillerod Hospital, Denmark
Helsingør hospital
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00624169
First received: February 15, 2008
Last updated: May 26, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention
Peptic Ulcer Perforation
 Procedure: An optimized perioperative course

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peptic Ulcer Perforation Study - an Optimized Perioperative Course for Patients Surgically Treated for Peptic Ulcer Perforation

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • All cause mortality rate [ Time Frame: Within 30 days of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: An optimized perioperative course
    A number of interventions before, during and after surgery
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients surgically treated for benign peptic ulcer perforation

Exclusion Criteria:

  • Age < 18 years
  • Pregnant and breastfeeding women
  • Malign ulcer perforation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624169

Locations
Denmark
Copenhagen University Hospital Bispebjerg
Copenhagen NV, Denmark, 2400
Copenhagen University Hospital Helsingør
Helsingor, Denmark, 3000
Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Copenhagen University Hospital Hillerød
Hillerød, Denmark, 3400
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Odense University Hospital
Odense, Denmark, 5000
Århus University Hospital
Århus, Denmark, 8000
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Odense University Hospital
Bispebjerg Hospital
Hvidovre University Hospital
Aarhus University Hospital
Hillerod Hospital, Denmark
Helsingør hospital
Investigators
Principal Investigator: Bo Belhage, MD, PhD Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg
Principal Investigator: Lars N Jørgensen, MD, PhD Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg
Principal Investigator: Iben Rosenberg, MD Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Hillerød
Principal Investigator: Anders U Neuenschwander, MD Department of Gastrointestinal Surgery, Copenhagen University Hospital Hillerød
Principal Investigator: Ulf Sigild, MD Department of Gastrointestinal Surgery, Copenhagen University Hospital Helsingør
Principal Investigator: Anne-Margrete Hedengran, MD Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Helsingør
Principal Investigator: Peter Holde, MD Department of Anaesthesiology and Intensive Care, Odense University Hospital
Principal Investigator: Erik Zimmermann-Nielsen, MD, PhD Department of Gastrointestinal Surgery, Odense University Hospital
Principal Investigator: Anita Lauritsen, MD Department of Anaesthesiology and Intensive Care Medicine, Århus University Hospital
Principal Investigator: Jørgen Bendix, MD Department of Gastrointestinal Surgery, Århus University Hospital
Principal Investigator: Sven Adamsen, MD Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
Principal Investigator: Morten H Møller, MD Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Principal Investigator: Ann M Møller, MD, PhD Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Principal Investigator: Jens-Ulrik S Jensen, MD Department of Clinical Microbiology / Copenhagen HIV Programme, Copenhagen University Hospital Hvidovre
Principal Investigator: Niels Fogh-Andersen, MD Department of Clinical Biochemistry, Copenhagen University Hospital Herlev
  More Information

Additional Information:
The danish website for the PULP study  This link exits the ClinicalTrials.gov site

No publications provided by Copenhagen University Hospital at Herlev

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Morten Hylander Møller. MD, Department of Anaesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00624169     History of Changes
Other Study ID Numbers: H-D-2007-0044
Study First Received: February 15, 2008
Last Updated: May 26, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
Perforated peptic ulcer
Mortality

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Perforation
Ulcer
Duodenal Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013