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

September 2, 2008 updated by: Erasme University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

as written above

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2334 CK
        • Diaconessenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
days of discharge
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Collaborators

Gastrostart

Investigators

  • Study Director: Johan Lange, PhD,MD, Erasmus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (ESTIMATE)

September 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2008

Last Update Submitted That Met QC Criteria

September 2, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAMA1
  • Gastrostart The Netherlands

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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