EndometriosisNCT04129879
a Novel Surgical Approach for Endometriosis Surgery
A study testing ABC technique in people with Endometriosis and Laparoscopy, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Laparoscopy
- What is being tested?
- ABC technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients who have endometriosis
- patients who approved their data to be used for research manner
- operations with only peritoneal endometriosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis, Laparoscopy
- Being tested
- ABC technique
- Keywords
- endometriosis, methylene blue dye
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC techniqueProcedure or surgery
The intraperitoneal use of methylene blue diluted isotonic sodium chloride solution to visualize endometriotic lesions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | all patients treated by conventional bare eye technique and then the use of methylene blue contrast technique to visualize endometriotic lesions perioperatively Receives: Procedure: ABC technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of samples taken from each region
Measured: retrospective 1 year period
Secondary outcomes (1)
number of endometriosis positivity came out of each excision
Measured: retrospective 1 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2014
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129879
- Sponsor's protocol ID
- AcibademU abc
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31449906
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABC Technique as a Novel Approach for Endometriosis Surgery
- ClinicalTrials.gov ID
- NCT04129879
- Acronym / sponsor ID
- AcibademU abc
- Conditions
- Endometriosis, Laparoscopy
- Keywords
- endometriosis, methylene blue dye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: ABC techniqueall patients treated by conventional bare eye technique and then the use of methylene blue contrast technique to visualize endometriotic lesions perioperatively |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients who have endometriosis
- patients who approved their data to be used for research manner
- operations with only peritoneal endometriosis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABC techniqueThe intraperitoneal use of methylene blue diluted isotonic sodium chloride solution to visualize endometriotic lesions | Procedure or surgery | 1 |
Primary outcome
number of samples taken from each region
Time frame: retrospective 1 year period
1 secondary outcome
number of endometriosis positivity came out of each excision
Time frame: retrospective 1 year period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Results publication: PubMed 31449906Abesadze 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABC technique in people with Endometriosis and Laparoscopy, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of samples taken from each region (time frame: retrospective 1 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.