The LAMA Trial: Laparoscopic Correction of Perforated Pep... | NCT00745667

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

NCT00745667

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Sep 3, 2008Estimated

Enrollment

109Actual

Phase

Not Applicable

Conditions

Perforated Peptic Ulcer

Interventions

laparoscopic surgery
Upper laparotomy

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Gastrostart The Netherlands

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1999

Primary Completion Date

Dec 2006Actual

Completion Date

Jan 2007Actual

First Submitted Date

Sep 2, 2008

First Submission Date that Met QC Criteria

Sep 2, 2008

First Posted Date

Sep 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2008

Last Update Posted Date

Sep 3, 2008Estimated

Name	Class
Gastrostart	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	laparoscopic	Procedure: laparoscopic surgery
2	Active Comparator	open correction	Procedure: Upper laparotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laparoscopic surgery	Procedure	laparoscopic correction perforated peptic ulcer	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
days of discharge		7 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria:

Pregnancy
Younger than 18 years
Unable to sign consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johan Lange, PhD,MD	Erasmus university hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diaconessenhuis		Leiden		2334 CK	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D010439	Peptic Ulcer Perforation
D010437	Peptic Ulcer

Ancestor Terms

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010535	Laparoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided