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

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. Identifier: NCT00745667
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : September 3, 2008
Information provided by:
Erasme University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Perforated Peptic Ulcer Procedure: laparoscopic surgery Procedure: Upper laparotomy Not Applicable

Detailed Description:
as written above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
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
Study Start Date : July 1999
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Procedure: laparoscopic surgery
laparoscopic correction perforated peptic ulcer
Active Comparator: 2
open correction
Procedure: Upper laparotomy
upper laparotomy for correction of perforated peptic ulcer

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

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

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

Inclusion Criteria:

  • All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria:

  • Pregnancy
  • Younger than 18 years
  • Unable to sign consent form

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 identifier (NCT number): NCT00745667

Leiden, Netherlands, 2334 CK
Sponsors and Collaborators
Erasme University Hospital
Study Director: Johan Lange, PhD,MD Erasmus university hospital

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

Keywords provided by Erasme University Hospital:
peptic ulcer

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