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

This study has been completed.
Information provided by:
Erasme University Hospital Identifier:
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
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 Blind (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
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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00745667

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

Responsible Party: Drs. M.J.O.E. Bertleff, MD, Diaconessenhuis Identifier: NCT00745667     History of Changes
Other Study ID Numbers: LAMA1
Gastrostart The Netherlands
Study First Received: September 2, 2008
Last Updated: September 2, 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 processed this record on April 28, 2017