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Fertility Surgery, Prospective Analysis

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ClinicalTrials.gov Identifier: NCT00463398
Recruitment Status : Unknown
Verified August 2010 by University Hospital, Gasthuisberg.
Recruitment status was:  Recruiting
First Posted : April 20, 2007
Last Update Posted : September 1, 2010
Sponsor:
Information provided by:
University Hospital, Gasthuisberg

Tracking Information
First Submitted Date April 18, 2007
First Posted Date April 20, 2007
Last Update Posted Date September 1, 2010
Study Start Date September 2006
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2008)
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 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Fertility Surgery, Prospective Analysis
Official Title Quality Control in Surgical Diagnosis and Treatment of Endometriosis.
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Endometriosis is confirmed by histologic examination of excised lesions
Sampling Method Non-Probability Sample
Study Population All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.
Condition Endometriosis
Intervention Not Provided
Study Groups/Cohorts Patients operated at the LUFc
All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 9, 2008)
600
Original Enrollment Not Provided
Estimated Study Completion Date August 2010
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT00463398
Other Study ID Numbers ML2818 - 20/02/2006 b
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christel Meuleman, MD, University Hospital, Gasthuisberg, Leuven, Belgium
Study Sponsor University Hospital, Gasthuisberg
Collaborators Not Provided
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
PRS Account University Hospital, Gasthuisberg
Verification Date August 2010