NCT00463398

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 1, 2010

Status Verified

August 1, 2010

Enrollment Period

3.9 years

First QC Date

April 18, 2007

Last Update Submit

August 31, 2010

Conditions

Keywords

EndometriosisFertility SurgeryQuality of LifePainSexual FunctionHealth economicsRecurrencePregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients operated at the LUFc

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

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • patients of other than the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (2)

  • 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, D'Hoore A, D'Hooghe 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Endometriosis is confirmed by histologic examination of excised lesions

MeSH Terms

Conditions

EndometriosisPainRecurrence

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Christel LC Meuleman, MD

    University Hospital Gasthuisberg, Catholic University, Leuven, Belgium

    PRINCIPAL INVESTIGATOR
  • Thomas D'Hooghe, MD, PhD

    University Hospital Gasthuisberg, Catholic University, Leuven, Belgium

    STUDY DIRECTOR

Central Study Contacts

Thomas D'Hooghe, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

September 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 1, 2010

Record last verified: 2010-08

Locations