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

Perforated Peptic Ulcer Clinical Trial

— LAMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745667
• Other study ID #: LAMA1
• Secondary ID: Gastrostart The
• Status: Completed
• Phase: N/A
• First received: September 2, 2008
• Last updated: September 2, 2008
• Start date: July 1999
• Est. completion date: January 2007

Study information

• Verified date: September 2008
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

as written above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria:

• Pregnancy

• Younger than 18 years

• Unable to sign consent form

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Perforation
• Perforated Peptic Ulcer
• Ulcer

Intervention

Procedure:
• laparoscopic surgery
laparoscopic correction perforated peptic ulcer
• Upper laparotomy
upper laparotomy for correction of perforated peptic ulcer

Locations

Country	Name	City	State
Netherlands	Diaconessenhuis	Leiden

Sponsors (2)

Lead Sponsor	Collaborator
Erasme University Hospital	Gastrostart

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days of discharge		7 days	Yes
Secondary	postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)		follow up 1 year	Yes