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Fertility Surgery, Prospective Analysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University Hospital, Gasthuisberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00463398
First received: April 18, 2007
Last updated: August 31, 2010
Last verified: August 2010
History of Changes
  Purpose

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.


Condition
Endometriosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality Control in Surgical Diagnosis and Treatment of Endometriosis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • complication rate, quality of life, pain, sexual activity, economic life circumstances, pregnancy rate, reintervention rate, recurrence rate [ Time Frame: 1 month preop, 6 - 12 - 18 and 24 months postop ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Endometriosis is confirmed by histologic examination of excised lesions


Estimated Enrollment: 600
Study Start Date: September 2006
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients operated at the LUFc
All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463398

Contacts
Contact: Christel LC Meuleman, MD +32 16 34 36 24 Christel.Meuleman@uz.kuleuven.be
Contact: Thomas D'Hooghe, MD, PhD +32 16 34 36 24 Thomas.D'Hooghe@uz.kuleuven.be

Locations
Belgium
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: Christel LC Meuleman, MD     +32 16 34 36 24     Christel.Meuleman@uz.kuleuven.be    
Contact: Thomas D'Hooghe, MD, PhD     +32 16 34 36 24     Thomas.dhooghe@uz.kuleuven.be    
Principal Investigator: Christel LC Meuleman, Md            
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: Christel LC Meuleman, MD     +32 16 34 36 24     Christel.Meuleman@uz.kuleuven.be    
Contact: Thomas D'Hooghe, MD, PhD     +32 16 34 36 24     Thomas.dhooghe@uz.kuleuven.be    
Principal Investigator: Christel LC Meuleman, MD            
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Christel LC Meuleman, MD University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
Study Director: Thomas D'Hooghe, MD, PhD University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
  More Information

No publications provided

Responsible Party: Christel Meuleman, MD, University Hospital, Gasthuisberg, Leuven, Belgium
ClinicalTrials.gov Identifier: NCT00463398     History of Changes
Other Study ID Numbers: ML2818 - 20/02/2006 b
Study First Received: April 18, 2007
Last Updated: August 31, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
Endometriosis
Fertility Surgery
Quality of Life
Pain
 Sexual Function
Health economics
Recurrence
Pregnancy

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013