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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00463398
Other study ID # ML2818 - 20/02/2006 b
Secondary ID
Status Recruiting
Phase N/A
First received April 18, 2007
Last updated August 31, 2010
Start date September 2006
Est. completion date August 2010

Study information

Verified date August 2010
Source University Hospital, Gasthuisberg
Contact Christel LC Meuleman, MD
Phone +32 16 34 36 24
Email Christel.Meuleman@uz.kuleuven.be
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

From September 2006 a prospective cohort study is conducted among all patients operated at the Leuven University Fertility Centre to evaluate clinical and economical outcome after CO2 laser laparoscopic fertility surgery.


Description:

The main outcome measurements are postoperative complications, pain, quality of life, sexual satisfaction, economic life circumstances, cumulative pregnancy rate and cumulative recurrence rate of endometriosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria:

- All patients

- operated at the Leuven University Fertility Centre of the Department of Obstetrics and Gynaecology of the University Hospitals Leuven, Leuven,Belgium,

- from September 2006 to August 2008.

Exclusion Criteria:

- patients of other than the Dutch language

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium University Hospital Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary complication rate, quality of life, pain, sexual activity, economic life circumstances, pregnancy rate, reintervention rate, recurrence rate 1 month preop, 6 - 12 - 18 and 24 months postop No
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