Peptic Ulcer Perforation Study (PULP)

May 26, 2010 updated by: Copenhagen University Hospital at Herlev

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen NV, Denmark, 2400
        • Copenhagen University Hospital Bispebjerg
      • Helsingor, Denmark, 3000
        • Copenhagen University Hospital Helsingør
      • Herlev, Denmark, 2730
        • Copenhagen University Hospital Herlev
      • Hillerød, Denmark, 3400
        • Copenhagen University Hospital Hillerød
      • Hvidovre, Denmark, 2650
        • Copenhagen University Hospital Hvidovre
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Århus, Denmark, 8000
        • Århus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients surgically treated for benign peptic ulcer perforation

Exclusion Criteria:

  • Age < 18 years
  • Pregnant and breastfeeding women
  • Malign ulcer perforation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality rate
Time Frame: Within 30 days of surgery
Within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Odense University Hospital
Aarhus University Hospital
Hvidovre University Hospital
Bispebjerg 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2007-0044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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