a Novel Surgical Approach for Endometriosis Surgery

Endometriosis Clinical Trial

Official title:

ABC Technique as a Novel Approach for Endometriosis Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129879
• Other study ID #: AcibademU abc
• Status: Completed
• Phase: N/A
• Start date: January 1, 2014
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 30, 2019
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Laparoscopy

Intervention

Procedure:
• ABC technique
The intraperitoneal use of methylene blue diluted isotonic sodium chloride solution to visualize endometriotic lesions

Locations

Country	Name	City	State
Turkey	Bahar Yuksel	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 Fol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of samples taken from each region		retrospective 1 year period
Secondary	number of endometriosis positivity came out of each excision		retrospective 1 year period