a Novel Surgical Approach for Endometriosis Surgery

ABC Technique as a Novel Approach for Endometriosis Surgery

Endometriosis is a chronic disease defined as the existence of endometrium like lesions outside of the uterine cavity. The diagnosis is based on examination of lesions under the microscope and capturing endometrial gland and stroma. The mostly used surgical technique to diagnose and treat endometriosis is laparoscopic surgery. In our novel technique for endometriosis surgery, we used methylene blue for its natural blue color to make endometriotic lesions more visible and to filter red, yellow and white colors reflecting from the peritoneal surface.

Study Overview

• Status: Completed
• Conditions: Endometriosis; Laparoscopy
• Intervention / Treatment: Procedure: ABC technique

Detailed Description

Endometriosis is a chronic disease defined as existence of endometrium like lesions outside of the uterine cavity. The diagnosis is based on examination of lesions under microscope and capturing endometrial gland and stroma. The prevalence of endometriosis upon women on their reproductive ages, all over the world is at least 10%. This prevalence depends on surgically proven lesions that are excised, according to the this the real prevalence is still unknown because of underdiagnosis and being unable to capture endometriotic lesions.

Endometriosis is usually described as having three subtypes, which are peritoneal, ovarian endometriomas and deep infiltrative endometriosis (DIE). Peritoneal endometriosis is the most undiagnosed type according to lack of diagnostic tests and being unrecognizable on imaging modalities while ovarian endometriomas and deep infiltrative endometriosis lesions can be realized by ultrasound or MRI imaging. Also, these three subtypes are mostly existing together and even with uterine endometriosis which is named as adenomyosis. Considering the difficulties of capturing an endometriotic lesion most of the surgeries done for deep endometriosis or ovarian endometriomas usually fail upon insufficient excision of the disease.

The main presentations of endometriosis are pain and infertility. Whether it can be thought the most devastating anatomical lesion may cause more pain, the pain of endometriosis is usually unrelated with the characteristics of pathology or severity of the disease. Therefore, a small lesion even not visible to the naked eye may cause more pain than a large DIE nodule. This knowledge arises the importance of threating all lesions on a symptomatic patient with pain.

The mostly used surgical technique to diagnose and treat endometriosis is laparoscopic surgery. Under laparoscopic scope endometriotic lesions can bee seen in black, red, white colors and as flat or polypoid. Human eye can see wave lengths between 400-700 nm. And it is not always easy to visualize all pathologies even with the 4 to 40 times magnification of usual laparoscopic scopes. Human vision under white-light reflection cannot easily discriminate different tissue types. Making color contrasts make objects easy to be catch by human eye.

In our novel technique for endometriosis surgery we used methylene blue for its natural blue color to make endometriotic lesions more visible and to filter red, yellow and white colors reflecting from peritoneal surface.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Bahar Yuksel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients who have endometriosis
• patients who approved their data to be used for research manner
• operations with only peritoneal endometriosis

Exclusion Criteria:

• operations without the diagnosis of endometriosis
• patients who have not approved their data to be used for research manner
• operations which also include endometriomas and/or deep infiltrative endometriosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; all patients treated by conventional bare eye technique and then the use of methylene blue contrast technique to visualize endometriotic lesions perioperatively	Procedure: ABC technique; The intraperitoneal use of methylene blue diluted isotonic sodium chloride solution to visualize endometriotic lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of samples taken from each region	retrospective 1 year period

Secondary Outcome Measures

Outcome Measure	Time Frame
number of endometriosis positivity came out of each excision	retrospective 1 year period

Collaborators and Investigators

• Sponsor: Acibadem University

Publications and helpful links

General Publications

• Abesadze E, Sehouli J, Mechsner S, Chiantera V. Possible Role of the Posterior Compartment Peritonectomy, as a Part of the Complex Surgery, Regarding Recurrence Rate, Improvement of Symptoms and Fertility Rate in Patients with Endometriosis, Long-Term Follow-Up. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1103-1111. doi: 10.1016/j.jmig.2019.08.019. Epub 2019 Aug 23.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: endometriosis; methylene blue dye
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: AcibademU abc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No