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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Stomach Diseases

ClinicalTrials.gov processed this record on October 21, 2014