Peptic Ulcer PerforationPULPNCT00624169
Peptic Ulcer Perforation Study
A study testing An optimized perioperative course in people with Peptic Ulcer Perforation, run by Copenhagen University Hospital at Herlev at 7 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Perforation
- What is being tested?
- An optimized perioperative course
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 7 sitesDenmark
- Study dates
- Nov 2007to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients surgically treated for benign peptic ulcer perforation
Who cannot join
- Age < 18 years
- Pregnant and breastfeeding women
- Malign ulcer perforation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Århus University Hospital
Aarhus, 8000
Copenhagen University Hospital Bispebjerg
Copenhagen NV, 2400
Copenhagen University Hospital Helsingør
Elsinore, 3000
Copenhagen University Hospital Herlev
Herlev, 2730
Copenhagen University Hospital Hillerød
Hillerød, 3400
Copenhagen University Hospital Hvidovre
Hvidovre, 2650
Odense University Hospital
Odense, 5000
About this study
Official title: 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.
- Conditions
- Peptic Ulcer Perforation
- Being tested
- An optimized perioperative course
- Keywords
- Perforated peptic ulcer, Mortality
- Medical subject headings
- Peptic Ulcer Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An optimized perioperative courseProcedure or surgery
A number of interventions before, during and after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality rate
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peptic Ulcer PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Bispebjerg Hospital, Hvidovre University Hospital, Aarhus University Hospital, Hillerod Hospital, Denmark, Helsingør hospital
- Investigators
- Bo Belhage, MD, PhD, Principal investigator, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital BispebjergLars N Jørgensen, MD, PhD, Principal investigator, Department of Gastrointestinal Surgery, Copenhagen University Hospital BispebjergIben Rosenberg, MD, Principal investigator, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital HillerødAnders U Neuenschwander, MD, Principal investigator, Department of Gastrointestinal Surgery, Copenhagen University Hospital HillerødUlf Sigild, MD, Principal investigator, Department of Gastrointestinal Surgery, Copenhagen University Hospital HelsingørAnne-Margrete Hedengran, MD, Principal investigator, Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital HelsingørPeter Holde, MD, Principal investigator, Department of Anaesthesiology and Intensive Care, Odense University HospitalErik Zimmermann-Nielsen, MD, PhD, Principal investigator, Department of Gastrointestinal Surgery, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624169
- Sponsor's protocol ID
- H-D-2007-0044
- Acronym
- PULP
- Status last verified
- May 2010
- First submitted
- 15 Feb 2008
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23215900Moller 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.
PubMed 21442610
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peptic Ulcer Perforation Study - an Optimized Perioperative Course for Patients Surgically Treated for Peptic Ulcer Perforation
- ClinicalTrials.gov ID
- NCT00624169
- Acronym / sponsor ID
- PULP / H-D-2007-0044
- Conditions
- Peptic Ulcer Perforation
- Keywords
- Perforated peptic ulcer, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Odense University Hospital, Bispebjerg Hospital, Hvidovre University Hospital, Aarhus University Hospital, Hillerod Hospital, Denmark, Helsingør hospital
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients surgically treated for benign peptic ulcer perforation
Key exclusion criteria (3 listed)
- Age < 18 years
- Pregnant and breastfeeding women
- Malign ulcer perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An optimized perioperative courseA number of interventions before, during and after surgery | Procedure or surgery | – |
Primary outcome
All cause mortality rate
Time frame: Within 30 days of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
- Derived from this study: PubMed 23215900Moller 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.
- Derived from this study: PubMed 21442610Moller 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.
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Falciformopexy for Treatment Perforated Peptic Ulcer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Belhage, MD, PhD principal investigator
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg
Lars N Jørgensen, MD, PhD principal investigator
Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg
Iben Rosenberg, MD principal investigator
Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Hillerød
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An optimized perioperative course in people with Peptic Ulcer Perforation, run by Copenhagen University Hospital at Herlev at 7 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality rate (time frame: Within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00624169, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.