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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Recruitment Status : Withdrawn (IP change Hospital)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
Sponsor:
Information provided by (Responsible Party):
Ignacio Rodriguez MSc, Institut Universitari Dexeus

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Group/Cohort Intervention/treatment
Patients with symptomatic endometriosis Procedure: laparoscopic surgery for deep endometriosis



Primary Outcome Measures :
  1. Recurrences [ Time Frame: Two years after surgery ]
    Evaluate clinical recurrence rate of endometriosis after complete surgery


Biospecimen Retention:   Samples With DNA
tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women with symptomatic deep endometriosis
Criteria

Inclusion Criteria:

  • patients with symptomatic endometriosis superior to 6 in a visual scale (VAS; Huskisson, 1974)diagnosed by ultrasound or MRI and suitable for laparoscopic surgery

Exclusion Criteria:

  • previous surgeries for deep endometriosis
  • Non complete surgery

Information from the National Library of Medicine

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


Locations
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Spain
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, Spain, 08037
Sponsors and Collaborators
Institut Universitari Dexeus
Investigators
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Principal Investigator: Alberto Vazquez, MD Hospital Quiron Dexeus
Additional Information:
Publications:
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Responsible Party: Ignacio Rodriguez MSc, Epidemiologist, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT01949597    
Other Study ID Numbers: DEX2013002
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: April 2016
Additional relevant MeSH terms:
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Endometriosis
Recurrence
Disease Attributes
Pathologic Processes