Perforated Peptic UlcerLAMANCT00745667
The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction
A study testing laparoscopic surgery and Upper laparotomy in people with Perforated Peptic Ulcer, run by Erasme University Hospital at 1 site in Netherlands.
Trial summary
This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction will be discharged 3 days sooner due to less postoperative pain and complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforated Peptic Ulcer
- What is being tested?
- laparoscopic surgery and Upper laparotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 1999to Jan 2007
- 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
- All patients clinical suspected for perforated peptic ulcer
Who cannot join
- Pregnancy
- Younger than 18 years
- Unable to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction by Upper Laparotomy
This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction will be discharged 3 days sooner due to less postoperative pain and complications.
Read the detailed description
as written above
- Conditions
- Perforated Peptic Ulcer
- Being tested
- laparoscopic surgery, Upper laparotomy
- Keywords
- laparoscopic, peptic ulcer
- Medical subject headings
- Peptic Ulcer Perforation, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
laparoscopic correction perforated peptic ulcer
Upper laparotomyProcedure or surgery
upper laparotomy for correction of perforated peptic ulcer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | laparoscopic Receives: Procedure: laparoscopic surgery |
| 2 | Active comparator | open correction Receives: Procedure: Upper laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
days of discharge
Measured: 7 days
Secondary outcomes (1)
postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)
Measured: follow up 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJul 1999
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated Peptic UlcerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gastrostart
- Investigators
- Johan Lange, PhD,MD, Study director, Erasmus university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745667
- Sponsor's protocol ID
- LAMA1
- Other IDs
- Gastrostart The Netherlands
- Acronym
- LAMA
- Status last verified
- Sep 2008
- First submitted
- 2 Sep 2008
- Last updated
- 3 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction by Upper Laparotomy
- ClinicalTrials.gov ID
- NCT00745667
- Acronym / sponsor ID
- LAMA / LAMA1
- Conditions
- Perforated Peptic Ulcer
- Keywords
- laparoscopic, peptic ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Gastrostart
- Study start
- Jul 1999
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 3 Sep 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.
This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction will be discharged 3 days sooner due to less postoperative pain and complications.
Detailed description
as written above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: laparoscopic surgerylaparoscopic |
| 2 | Active comparator | Procedure: Upper laparotomyopen correction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients clinical suspected for perforated peptic ulcer
Key exclusion criteria (3 listed)
- Pregnancy
- Younger than 18 years
- Unable to sign consent form
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 |
|---|---|---|
| laparoscopic surgerylaparoscopic correction perforated peptic ulcer | Procedure or surgery | 1 |
| Upper laparotomyupper laparotomy for correction of perforated peptic ulcer | Procedure or surgery | 2 |
Primary outcome
days of discharge
Time frame: 7 days
1 secondary outcome
postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)
Time frame: follow up 1 year
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 3 Sep 2008.
Related trials for Perforated Peptic Ulcer
Not yet recruiting
Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
Perforated Peptic Ulcer, Peptic Ulcer Perforation
Not yet recruiting
Falciformopexy for Treatment Perforated Peptic Ulcer.
Perforated Peptic Ulcer
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.
Johan Lange, PhD,MD study director
Erasmus university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic surgery and Upper laparotomy in people with Perforated Peptic Ulcer, run by Erasme University Hospital at 1 site in Netherlands.
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 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
days of discharge (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2008.