Back to resultsThe LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction (LAMA)
Primary Purpose
Perforated Peptic Ulcer
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
laparoscopic surgery
Upper laparotomy
Sponsored by
About this trial
This is an interventional treatment trial for Perforated Peptic Ulcer focused on measuring laparoscopic, peptic ulcer
Eligibility Criteria
Inclusion Criteria:
- All patients clinical suspected for perforated peptic ulcer
Exclusion Criteria:
- Pregnancy
- Younger than 18 years
- Unable to sign consent form
Sites / Locations
- Diaconessenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
laparoscopic
open correction
Outcomes
Primary Outcome Measures
days of discharge
Secondary Outcome Measures
postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)
Full Information
NCT ID
NCT00745667
First Posted
September 2, 2008
Last Updated
September 2, 2008
Sponsor
Erasme University Hospital
Collaborators
Gastrostart
1. Study Identification
Unique Protocol Identification Number
NCT00745667
Brief Title
The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction
Acronym
LAMA
Official Title
The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction by Upper Laparotomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Erasme University Hospital
Collaborators
Gastrostart
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
as written above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Peptic Ulcer
Keywords
laparoscopic, peptic ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
laparoscopic
Arm Title
2
Arm Type
Active Comparator
Arm Description
open correction
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Intervention Description
laparoscopic correction perforated peptic ulcer
Intervention Type
Procedure
Intervention Name(s)
Upper laparotomy
Intervention Description
upper laparotomy for correction of perforated peptic ulcer
Primary Outcome Measure Information:
Title
days of discharge
Time Frame
7 days
Secondary Outcome Measure Information:
Title
postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)
Time Frame
follow up 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients clinical suspected for perforated peptic ulcer
Exclusion Criteria:
Pregnancy
Younger than 18 years
Unable to sign consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Lange, PhD,MD
Organizational Affiliation
Erasmus university hospital
Official's Role
Study Director
Facility Information:
Facility Name
Diaconessenhuis
City
Leiden
ZIP/Postal Code
2334 CK
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction
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