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:

MedlinePlus related topics: Endometriosis

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University Hospital, Gasthuisberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Van den Broeck U, Meuleman C, Tomassetti C, D'Hoore A, Wolthuis A, Van Cleynenbreugel B, Vergote I, Enzlin P, D'Hooghe T. Effect of laparoscopic surgery for moderate and severe endometriosis on depression, relationship satisfaction and sexual functioning: comparison of patients with and without bowel resection. Hum Reprod. 2013 Sep;28(9):2389-97. doi: 10.1093/humrep/det260. Epub 2013 Jun 24.

Meuleman C, Tomassetti C, Wolthuis A, Van Cleynenbreugel B, Laenen A, Penninckx F, Vergote I, DʼHoore A, DʼHooghe T. Clinical outcome after radical excision of moderate-severe endometriosis with or without bowel resection and reanastomosis: a prospective cohort study. Ann Surg. 2014 Mar;259(3):522-31. doi: 10.1097/SLA.0b013e31828dfc5c.


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 February 27, 2015

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