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

NCT01949597 | Withdrawn

• 1 other identifier: DEX2013002
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Endometriosis; Recurrences; Margins in the Specimen; Laparoscopy; Prognosis Factors

Outcome Measures

Primary Outcomes (1)

• Recurrences

  Evaluate clinical recurrence rate of endometriosis after complete surgery

  Two years after surgery

Study Arms (1)

Patients with symptomatic endometriosis

Procedure: laparoscopic surgery for deep endometriosis

Interventions

laparoscopic surgery for deep endometriosis PROCEDURE

Patients with symptomatic endometriosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women with symptomatic deep endometriosis

You may qualify if:

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

You may not qualify if:

• previous surgeries for deep endometriosis
• Non complete surgery

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (1)

Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Barcelona, 08037, Spain

Location

Related 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.

  PMID: 19279046 BACKGROUND

• 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.

  PMID: 22416007 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Recurrence

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Alberto Vazquez, MD

  Hospital Quiron Dexeus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Study Record Dates

• First Submitted: September 20, 2013
• First Posted: September 24, 2013
• Study Start: April 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 12, 2020

Record last verified: 2016-04

Locations

ES (1)