a Novel Surgical Approach for Endometriosis Surgery

NCT04129879 | Completed

• 1 other identifier: AcibademU abc
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis; Laparoscopy

Keywords

endometriosis; methylene blue dye

Outcome Measures

Primary Outcomes (1)

• number of samples taken from each region

  retrospective 1 year period

Secondary Outcomes (1)

• number of endometriosis positivity came out of each excision

  retrospective 1 year period

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

ABC technique PROCEDURE

The intraperitoneal use of methylene blue diluted isotonic sodium chloride solution to visualize endometriotic lesions

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: it is a gynecologic situation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Bahar Yuksel

Istanbul, 34000, Turkey (Türkiye)

Location

Related 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 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.

  PMID: 31449906 RESULT

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients undergone for laparoscopic surgery for endometriosis had both approaches with either bare eye and with the help of methylene blue contrast agent

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: January 1, 2014
• Primary Completion: December 31, 2014
• Study Completion: September 30, 2019
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

TU (1)