NCT00624169

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

2.1 years

First QC Date

February 15, 2008

Last Update Submit

May 26, 2010

Conditions

Peptic Ulcer Perforation

Keywords

Perforated peptic ulcerMortality

Outcome Measures

Primary Outcomes (1)

  • All cause mortality rate

    Within 30 days of surgery

Interventions

An optimized perioperative coursePROCEDURE

A number of interventions before, during and after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients surgically treated for benign peptic ulcer perforation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Århus University Hospital

Aarhus, 8000, Denmark

Location

Copenhagen University Hospital Bispebjerg

Copenhagen NV, 2400, Denmark

Location

Copenhagen University Hospital Helsingør

Elsinore, 3000, Denmark

Location

Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

Location

Copenhagen University Hospital Hillerød

Hillerød, 3400, Denmark

Location

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 23215900DERIVED

  • 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.

    PMID: 21442610DERIVED

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

DK(7)