Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis
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| First Received Date ICMJE | April 17, 2007 | ||||||||
| Last Updated Date | February 19, 2009 | ||||||||
| Start Date ICMJE | September 1996 | ||||||||
| Primary Completion Date | July 2004 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
complication rate, cumulative recurrence and cumulative fertility rate, pain, quality of life and sexual satisfaction [ Time Frame: median follow-up: 29 months (range 6 - 76 months) ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00461838 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis | ||||||||
| Official Title ICMJE | Outcome After Multidisciplinary CO2 Laser Laparoscopic Excision of Deep Infiltrating Colorectal Endometriosis | ||||||||
| Brief Summary | Improved pain, sexuality and quality of life, high fertility and low complication and recurrence rates after multidisciplinary CO2 laser laparoscopic excision of deep infiltrating colorectal endometriosis. |
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| Detailed Description | All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004. All 56 multidisciplinary operated patients were asked to complete the Oxford Endometriosis Quality of Life questionnaire, a sexual activity questionnaire and visual analogue scales (VAS) for dysmenorroe, chronic pelvic pain and deep dyspareunia, to compare their status before surgery and at the moment of the evaluation (January 2005). |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Endometriosis was proven by histologic examination of excised lesions. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004. |
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| Condition ICMJE | Endometriosis | ||||||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | 1
All women (n=56) who had undergone CO2 laser laparoscopic radical excision of deep infiltrating endometriosis with active involvement of colorectal surgeon and/or urologist were selected retrospectively from the list of all patients (n=more than 2000) operated at the Leuven University Fertility Centre (LUFc) between September 1996 and July 2004.
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 56 | ||||||||
| Completion Date | July 2004 | ||||||||
| Primary Completion Date | July 2004 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00461838 | ||||||||
| Other Study ID Numbers ICMJE | ML2818 - 22/10/2004 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christel Meuleman, MD, University Hospitals Leuven | ||||||||
| Study Sponsor ICMJE | University Hospital, Gasthuisberg | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Gasthuisberg | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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