Recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen

NCT ID: NCT01949597

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Deep Endometriosis Recurrences Margins in the Specimen Laparoscopy Prognosis Factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with symptomatic endometriosis

laparoscopic surgery for deep endometriosis

Intervention Type PROCEDURE

Interventions

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laparoscopic surgery for deep endometriosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Dexeus

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Rodriguez MSc

Epidemiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberto Vazquez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Quiron Dexeus

Locations

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Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Guo SW. Recurrence of endometriosis and its control. Hum Reprod Update. 2009 Jul-Aug;15(4):441-61. doi: 10.1093/humupd/dmp007. Epub 2009 Mar 11.

Reference Type BACKGROUND
PMID: 19279046 (View on PubMed)

Mabrouk M, Spagnolo E, Raimondo D, D'Errico A, Caprara G, Malvi D, Catena F, Ferrini G, Paradisi R, Seracchioli R. Segmental bowel resection for colorectal endometriosis: is there a correlation between histological pattern and clinical outcomes? Hum Reprod. 2012 May;27(5):1314-9. doi: 10.1093/humrep/des048. Epub 2012 Mar 12.

Reference Type BACKGROUND
PMID: 22416007 (View on PubMed)

Related Links

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Other Identifiers

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DEX2013002

Identifier Type: -

Identifier Source: org_study_id

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