Peptic Ulcer Perforation Study (PULP)
Primary Purpose
Peptic Ulcer Perforation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
An optimized perioperative course
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer Perforation focused on measuring Perforated peptic ulcer, Mortality
Eligibility Criteria
Inclusion Criteria:
- Patients surgically treated for benign peptic ulcer perforation
Exclusion Criteria:
- Age < 18 years
- Pregnant and breastfeeding women
- Malign ulcer perforation
Sites / Locations
- Copenhagen University Hospital Bispebjerg
- Copenhagen University Hospital Helsingør
- Copenhagen University Hospital Herlev
- Copenhagen University Hospital Hillerød
- Copenhagen University Hospital Hvidovre
- Odense University Hospital
- Århus University Hospital
Outcomes
Primary Outcome Measures
All cause mortality rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00624169
First Posted
February 15, 2008
Last Updated
May 26, 2010
Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Odense University Hospital, Bispebjerg Hospital, Hvidovre University Hospital, Aarhus University Hospital, Hillerod Hospital, Denmark, Helsingør hospital
1. Study Identification
Unique Protocol Identification Number
NCT00624169
Brief Title
Peptic Ulcer Perforation Study
Acronym
PULP
Official Title
Peptic Ulcer Perforation Study - an Optimized Perioperative Course for Patients Surgically Treated for Peptic Ulcer Perforation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Odense University Hospital, Bispebjerg Hospital, Hvidovre University Hospital, Aarhus University Hospital, Hillerod Hospital, Denmark, Helsingør hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Perforation
Keywords
Perforated peptic ulcer, Mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
An optimized perioperative course
Intervention Description
A number of interventions before, during and after surgery
Primary Outcome Measure Information:
Title
All cause mortality rate
Time Frame
Within 30 days of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients surgically treated for benign peptic ulcer perforation
Exclusion Criteria:
Age < 18 years
Pregnant and breastfeeding women
Malign ulcer perforation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Belhage, MD, PhD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars N Jørgensen, MD, PhD
Organizational Affiliation
Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iben Rosenberg, MD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Hillerød
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anders U Neuenschwander, MD
Organizational Affiliation
Department of Gastrointestinal Surgery, Copenhagen University Hospital Hillerød
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulf Sigild, MD
Organizational Affiliation
Department of Gastrointestinal Surgery, Copenhagen University Hospital Helsingør
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne-Margrete Hedengran, MD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Helsingør
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Holde, MD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care, Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erik Zimmermann-Nielsen, MD, PhD
Organizational Affiliation
Department of Gastrointestinal Surgery, Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anita Lauritsen, MD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care Medicine, Århus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jørgen Bendix, MD
Organizational Affiliation
Department of Gastrointestinal Surgery, Århus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sven Adamsen, MD
Organizational Affiliation
Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morten H Møller, MD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann M Møller, MD, PhD
Organizational Affiliation
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens-Ulrik S Jensen, MD
Organizational Affiliation
Department of Clinical Microbiology / Copenhagen HIV Programme, Copenhagen University Hospital Hvidovre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niels Fogh-Andersen, MD
Organizational Affiliation
Department of Clinical Biochemistry, Copenhagen University Hospital Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Bispebjerg
City
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Copenhagen University Hospital Helsingør
City
Helsingor
ZIP/Postal Code
3000
Country
Denmark
Facility Name
Copenhagen University Hospital Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Copenhagen University Hospital Hillerød
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Århus University Hospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23215900
Citation
Moller MH, Vester-Andersen M, Thomsen RW. Long-term mortality following peptic ulcer perforation in the PULP trial. A nationwide follow-up study. Scand J Gastroenterol. 2013 Feb;48(2):168-75. doi: 10.3109/00365521.2012.746393. Epub 2012 Dec 10.
Results Reference
derived
PubMed Identifier
21442610
Citation
Moller MH, Adamsen S, Thomsen RW, Moller AM; Peptic Ulcer Perforation (PULP) trial group. Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation. Br J Surg. 2011 Jun;98(6):802-10. doi: 10.1002/bjs.7429. Epub 2011 Mar 25.
Results Reference
derived
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