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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01949597
• Other study ID #: DEX2013002
• Status: Withdrawn
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2016
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Endometriosis
• Endometriosis
• Laparoscopy
• Margins in the Specimen
• Prognosis Factors
• Recurrence
• Recurrences

Intervention

Procedure:
• laparoscopic surgery for deep endometriosis

Locations

Country	Name	City	State
Spain	Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrences	Evaluate clinical recurrence rate of endometriosis after complete surgery	Two years after surgery

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