Clinical trial NCT01949597: Recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen
Official title: Recurrences After Surgery for Deep Endometriosis Depending on the Involvement of the Surgical Margins in the Specimen
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Deep Endometriosis
Recurrences
Margins in the Specimen
Laparoscopy
Prognosis Factors
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with symptomatic deep endometriosis

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.

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.

Eligibility 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

Primary outcomes:
measure: Recurrences
timeFrame: Two years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Study officials:
affiliation: Hospital Quiron Dexeus
name: Alberto Vazquez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.