EndometriosisNCT00463398
Fertility Surgery, Prospective Analysis
An observational study of Endometriosis, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2006to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.
Who may be able to join
- 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.
Who cannot join
- patients of other than the Dutch language
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven, 3000
Christel LC Meuleman, MD, +32 16 34 36 24, Christel.Meuleman@uz.kuleuven.be
Thomas D'Hooghe, MD, PhD, +32 16 34 36 24, Thomas.dhooghe@uz.kuleuven.be
About this study
Official title: Quality Control in Surgical Diagnosis and Treatment of Endometriosis.
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.
Read the 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.
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Fertility Surgery, Quality of Life, Pain, Sexual Function, Health economics, Recurrence, Pregnancy
- Medical subject headings
- Endometriosis, Pain, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated at the LUFc | All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008. |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate, quality of life, pain, sexual activity, economic life circumstances, pregnancy rate, reintervention rate, recurrence rate
Measured: 1 month preop, 6 - 12 - 18 and 24 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startSep 2006
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Investigators
- Christel LC Meuleman, MD, Principal investigator, University Hospital Gasthuisberg, Catholic University, Leuven, BelgiumThomas D'Hooghe, MD, PhD, Study director, University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463398
- Sponsor's protocol ID
- ML2818 - 20/02/2006 b
- Status last verified
- Aug 2010
- First submitted
- 18 Apr 2007
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23798058Meuleman 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.
PubMed 23579578
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control in Surgical Diagnosis and Treatment of Endometriosis.
- ClinicalTrials.gov ID
- NCT00463398
- Acronym / sponsor ID
- ML2818 - 20/02/2006 b
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Fertility Surgery, Quality of Life, Pain, Sexual Function, Health economics, Recurrence, Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients operated at the LUFc | – | –All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients operated at the Leuven University Fertility Centre (LUFc) between september 2006 and August 2008.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- patients of other than the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2010.
- Derived from this study: PubMed 23798058Van 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.
- Derived from this study: PubMed 23579578Meuleman 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.
Related trials for Endometriosis
Not yet recruiting
Effects of Ashwagandha Supplementation on Quality of Life and Well-Being in Women With Endometriosis
Endometriosis, Quality of Life
RecruitingPhase 1
Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
Endometriosis
Active, not recruiting
Feasibility of a Mindfulness Intervention for Endometriosis Surgery
Endometriosis, Pain
Recruiting
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
Endometriosis, Microbiome Dysbiosis
RecruitingObservational study
Retinal Imaging for Systemic Inflammation in Endometriosis
Endometriosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christel LC Meuleman, MD principal investigator
University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
Thomas D'Hooghe, MD, PhD study director
University Hospital Gasthuisberg, Catholic University, Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by University Hospital, Gasthuisberg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christel LC Meuleman, MD (+32 16 34 36 24, Christel.Meuleman@uz.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2010; AzTrials last refreshed its copy on 28 Oct 2026.