a Novel Surgical Approach for Endometriosis Surgery
Primary Purpose
Endometriosis, Laparoscopy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ABC technique
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometriosis focused on measuring endometriosis, methylene blue dye
Eligibility Criteria
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
Sites / Locations
- Bahar Yuksel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
all patients treated by conventional bare eye technique and then the use of methylene blue contrast technique to visualize endometriotic lesions perioperatively
Outcomes
Primary Outcome Measures
number of samples taken from each region
Secondary Outcome Measures
number of endometriosis positivity came out of each excision
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04129879
Brief Title
a Novel Surgical Approach for Endometriosis Surgery
Official Title
ABC Technique as a Novel Approach for Endometriosis Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Laparoscopy
Keywords
endometriosis, methylene blue dye
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients 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)
Allocation
N/A
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
all patients treated by conventional bare eye technique and then the use of methylene blue contrast technique to visualize endometriotic lesions perioperatively
Intervention Type
Procedure
Intervention Name(s)
ABC technique
Intervention Description
The intraperitoneal use of methylene blue diluted isotonic sodium chloride solution to visualize endometriotic lesions
Primary Outcome Measure Information:
Title
number of samples taken from each region
Time Frame
retrospective 1 year period
Secondary Outcome Measure Information:
Title
number of endometriosis positivity came out of each excision
Time Frame
retrospective 1 year period
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
it is a gynecologic situation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bahar Yuksel
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31449906
Citation
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.
Results Reference
result
Learn more about this trial
a Novel Surgical Approach for Endometriosis Surgery
We'll reach out to this number within 24 hrs