Recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen
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|ClinicalTrials.gov Identifier: NCT01949597|
Recruitment Status : Withdrawn (IP change Hospital)
First Posted : September 24, 2013
Last Update Posted : February 12, 2020
The recurrence of endometriosis after surgery a formidable challenge for the gynecologist. Recurrence rates reported in the literature are very high, being 21.5% at 2 years and 40-50% at 5 years. Several theories attempt to explain these high figures. The three most widely accepted are:
- The presence of residual endometriotic tissue or residual endometriotic cells not completely eradicated during surgery
- The growth of undetected microscopic endometriosis during surgery
- The development of endometriotic lesions de novo Patients with symptomatic endometriosis diagnosed by ultrasound or MRI and suitable for surgery will participate in the study. The surgical specimens sent for pathology from bladder, vagina, uterosacral, sigma or rectum will be properly marked for studying the presence of endometriosis.
|Condition or disease||Intervention/treatment|
|Deep Endometriosis Recurrences Margins in the Specimen Laparoscopy Prognosis Factors||Procedure: laparoscopic surgery for deep endometriosis|
Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for deep endometriosis will participate in the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will participate in the trial. All patient information will be confidential and only be available to researches involved in the study.
Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen|
|Estimated Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Patients with symptomatic endometriosis||
Procedure: laparoscopic surgery for deep endometriosis
- Recurrences [ Time Frame: Two years after surgery ]Evaluate clinical recurrence rate of endometriosis after complete surgery
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949597
|Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus|
|Barcelona, Spain, 08037|
|Principal Investigator:||Alberto Vazquez, MD||Hospital Quiron Dexeus|