Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Gastrostart
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00745667
First received: September 2, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

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

Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • days of discharge [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 2, 2008
Last Updated: September 2, 2008
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Erasme University Hospital:
laparoscopic
peptic ulcer

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

ClinicalTrials.gov processed this record on May 19, 2013