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

Erasme University Hospital109 enrolled

Overview

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.

as written above

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

109

Conditions

Perforated Peptic Ulcer

Interventions

laparoscopic surgeryPROCEDURE

laparoscopic correction perforated peptic ulcer

Upper laparotomyPROCEDURE

upper laparotomy for correction of perforated peptic ulcer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients clinical suspected for perforated peptic ulcer Exclusion Criteria: * Pregnancy * Younger than 18 years * Unable to sign consent form

Locations (1)

Diaconessenhuis

Leiden, Netherlands

Outcomes

Primary Outcomes

days of discharge

Time frame: 7 days

Secondary Outcomes

postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)

Time frame: follow up 1 year

Data from ClinicalTrials.gov

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