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The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction (LAMA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745667
First Posted: September 3, 2008
Last Update Posted: September 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gastrostart
Information provided by:
Erasme University Hospital
  Purpose
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.

Condition Intervention
Perforated Peptic Ulcer Procedure: laparoscopic surgery Procedure: Upper laparotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction by Upper Laparotomy

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • days of discharge [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol) [ Time Frame: follow up 1 year ]

Enrollment: 109
Study Start Date: July 1999
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
laparoscopic
Procedure: laparoscopic surgery
laparoscopic correction perforated peptic ulcer
Active Comparator: 2
open correction
Procedure: Upper laparotomy
upper laparotomy for correction of perforated peptic ulcer

Detailed Description:
as written above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria:

  • Pregnancy
  • Younger than 18 years
  • Unable to sign consent form
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745667


Locations
Netherlands
Diaconessenhuis
Leiden, Netherlands, 2334 CK
Sponsors and Collaborators
Erasme University Hospital
Gastrostart
Investigators
Study Director: Johan Lange, PhD,MD Erasmus university hospital
  More Information

Responsible Party: Drs. M.J.O.E. Bertleff, MD, Diaconessenhuis
ClinicalTrials.gov Identifier: NCT00745667     History of Changes
Other Study ID Numbers: LAMA1
Gastrostart The Netherlands
First Submitted: September 2, 2008
First Posted: September 3, 2008
Last Update Posted: September 3, 2008
Last Verified: September 2008

Keywords provided by Erasme University Hospital:
laparoscopic
peptic ulcer

Additional relevant MeSH terms:
Ulcer
Peptic Ulcer
Peptic Ulcer Perforation
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases