NCT00745667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
Last Updated

September 3, 2008

Status Verified

September 1, 2008

Enrollment Period

7.4 years

First QC Date

September 2, 2008

Last Update Submit

September 2, 2008

Conditions

Perforated Peptic Ulcer

Keywords

laparoscopicpeptic ulcer

Outcome Measures

Primary Outcomes (1)

  • days of discharge

    7 days

Secondary Outcomes (1)

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

    follow up 1 year

Study Arms (2)

1

ACTIVE COMPARATOR

laparoscopic

Procedure: laparoscopic surgery

2

ACTIVE COMPARATOR

open correction

Procedure: Upper laparotomy

Interventions

laparoscopic surgeryPROCEDURE

laparoscopic correction perforated peptic ulcer

1
Upper laparotomyPROCEDURE

upper laparotomy for correction of perforated peptic ulcer

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients clinical suspected for perforated peptic ulcer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diaconessenhuis

Leiden, 2334 CK, Netherlands

Location

MeSH Terms

Conditions

Peptic Ulcer PerforationPeptic Ulcer

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Johan Lange, PhD,MD

    Erasmus university hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

July 1, 1999

Primary Completion

December 1, 2006

Study Completion

January 1, 2007

Last Updated

September 3, 2008

Record last verified: 2008-09

Locations

NL(1)