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

Not Applicable

Completed

• Conditions: Perforated Peptic Ulcer
• Interventions: Procedure: laparoscopic surgery; Procedure: Upper laparotomy

• Registration Number: NCT00745667
• Lead Sponsor: Erasme University Hospital

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

Study Timeline

• Study Start: 1999-07
• Primary Completion: 2006-12
• Study Completion: 2007-01
• Status Verified: 2008-09
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Last Update Submitted: 2008-09-02
• Study First Posted: 2008-09-03
• Last Update Posted: 2008-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	laparoscopic surgery	laparoscopic
2	Upper laparotomy	open correction

Primary Outcome Measures

Name	Time	Method
days of discharge	7 days

Secondary Outcome Measures

Name	Time	Method
postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)	follow up 1 year

Trial Locations

Locations (1)

Diaconessenhuis; 🇳🇱 Leiden, Netherlands