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

NCT ID: NCT00745667

Last Updated: 2008-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2007-01-31

Brief Summary

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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

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as written above

Conditions

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Perforated Peptic Ulcer

Keywords

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laparoscopic peptic ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

laparoscopic

Group Type ACTIVE_COMPARATOR

laparoscopic surgery

Intervention Type PROCEDURE

laparoscopic correction perforated peptic ulcer

2

open correction

Group Type ACTIVE_COMPARATOR

Upper laparotomy

Intervention Type PROCEDURE

upper laparotomy for correction of perforated peptic ulcer

Interventions

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laparoscopic surgery

laparoscopic correction perforated peptic ulcer

Intervention Type PROCEDURE

Upper laparotomy

upper laparotomy for correction of perforated peptic ulcer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria

* Pregnancy
* Younger than 18 years
* Unable to sign consent form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gastrostart

OTHER

Sponsor Role collaborator

Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Diaconessenhuis

Principal Investigators

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Johan Lange, PhD,MD

Role: STUDY_DIRECTOR

Erasmus university hospital

Locations

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Diaconessenhuis

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Gastrostart The Netherlands

Identifier Type: -

Identifier Source: secondary_id

LAMA1

Identifier Type: -

Identifier Source: org_study_id