Clinical trial NCT00624169: Peptic Ulcer Perforation Study
Official title: Peptic Ulcer Perforation Study - an Optimized Perioperative Course for Patients Surgically Treated for Peptic Ulcer Perforation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peptic Ulcer Perforation
Keywords: Perforated peptic ulcer
Mortality
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Bispebjerg Hospital
name: Hvidovre University Hospital
name: Aarhus University Hospital
name: Hillerod Hospital, Denmark
name: Helsingør hospital
First posted: 2008-02-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Patients surgically treated for benign peptic ulcer perforation

Exclusion Criteria:

* Age \< 18 years
* Pregnant and breastfeeding women
* Malign ulcer perforation

Primary outcomes:
measure: All cause mortality rate
timeFrame: Within 30 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Copenhagen University Hospital Bispebjerg
city: Helsingor
country: Denmark
facility: Copenhagen University Hospital Helsingør
city: Herlev
country: Denmark
facility: Copenhagen University Hospital Herlev
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital Hillerød
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
city: Odense
country: Denmark
facility: Odense University Hospital
city: Århus
country: Denmark
facility: Århus University Hospital
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg
name: Bo Belhage, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg
name: Lars N Jørgensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Hillerød
name: Iben Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastrointestinal Surgery, Copenhagen University Hospital Hillerød
name: Anders U Neuenschwander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastrointestinal Surgery, Copenhagen University Hospital Helsingør
name: Ulf Sigild, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Helsingør
name: Anne-Margrete Hedengran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care, Odense University Hospital
name: Peter Holde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastrointestinal Surgery, Odense University Hospital
name: Erik Zimmermann-Nielsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Århus University Hospital
name: Anita Lauritsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastrointestinal Surgery, Århus University Hospital
name: Jørgen Bendix, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev
name: Sven Adamsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
name: Morten H Møller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev
name: Ann M Møller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Microbiology / Copenhagen HIV Programme, Copenhagen University Hospital Hvidovre
name: Jens-Ulrik S Jensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Biochemistry, Copenhagen University Hospital Herlev
name: Niels Fogh-Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.