a Novel Surgical Approach for Endometriosis Surgery

Sponsor
Acibadem University (Other)
Overall Status
Completed
CT.gov ID
NCT04129879
Collaborator
(none)
115
1
1
68.9
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: ABC technique
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
115 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
patients undergone for laparoscopic surgery for endometriosis had both approaches with either bare eye and with the help of methylene blue contrast agentpatients undergone for laparoscopic surgery for endometriosis had both approaches with either bare eye and with the help of methylene blue contrast agent
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
ABC Technique as a Novel Approach for Endometriosis Surgery
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 31, 2014
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. number of samples taken from each region [retrospective 1 year period]

Secondary Outcome Measures

  1. number of endometriosis positivity came out of each excision [retrospective 1 year period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bahar Yuksel Istanbul Turkey 34000

Sponsors and Collaborators

  • Acibadem University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Acibadem University
ClinicalTrials.gov Identifier:
NCT04129879
Other Study ID Numbers:
  • AcibademU abc
First Posted:
Oct 17, 2019
Last Update Posted:
Oct 17, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Acibadem University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2019