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

Withdrawn

• Conditions: Deep Endometriosis; Recurrences; Margins in the Specimen; Laparoscopy; Prognosis Factors
• Interventions: Procedure: laparoscopic surgery for deep endometriosis

• Registration Number: NCT01949597
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-24
• Status Verified: 2016-04
• Study Start: 2016-04
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with symptomatic endometriosis	laparoscopic surgery for deep endometriosis	-

Primary Outcome Measures

Name	Time	Method
Recurrences	Two years after surgery	Evaluate clinical recurrence rate of endometriosis after complete surgery

Trial Locations

Locations (1)

Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain