Endometriosis Outside PelvisNCT04639063
Assessment of Surgically Removed Abdominal Wall Endometriomas
An observational study of Endometriosis Outside Pelvis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
A retrospective review of all patients who underwent surgery for an anterior abdominal wall mass which confirmed by pathology examination as an endometrioma will be completely performed. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women only
- Conditions the study is for
- Endometriosis Outside Pelvis
- What is being tested?
- Microscopic examination using H&E stained slides
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Oct 2020to 20 Dec 2020
- Phase
- Observational
- 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 15 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients treated in our hospital and pathologically examined in our hospital
Who may be able to join
- Female
- Surgically removed abdominal wall endometrioma
Who cannot join
- Male (very very rare to occur)
- medically treated enodmetrioma
- Outside treated patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinico-pathological Assessment of Surgically Removed Abdominal Wall Endometriomas
A retrospective review of all patients who underwent surgery for an anterior abdominal wall mass which confirmed by pathology examination as an endometrioma will be completely performed. The clinical data will be recorded and pathology report diagnosis will be correlated with the clinical data to assess the possible causes of endometrioma in the women treated in our tertiary hospital and the efficacy of the surgical excision.
Read the detailed description
Our hospital is a tertiary center for performing Cesarean sections, external endometriosis (Endometrioma) is a challenging complication for this operation, many treatment choices are available and the most common is the surgical excision, however recurrence could be seen after the surgical operation. We assess all patients who underwent surgical excision for abdominal wall endometriomas in our hospital by retrieving the medical files and pathology reports to study the possible age group,causes and duration of endometriomas. Also the rate of enodmetriomas among the previously experienced females with cesarean section operations. Pathological diagnosis tools will be also assessed.
Ethical approval was obtained from the local committee. Results will be statistically assessed using SPSS programm.
- Conditions
- Endometriosis Outside Pelvis
- Being tested
- Microscopic examination using H&E stained slides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic examination using H&E stained slidesOther
Also called CD10 immunohistochemistry
Reexamination of the stained slides of the patients from the hospital archive and adding a CD10 stain when required
| Study group | Role | What they receive |
|---|---|---|
| Cesarean sectioned | All females who treated in our hospital by Cesarean section operation during two-years-period | |
| Complicated with Abdominal wall endometriosis | All the surgically excised endometrioma cases during the same time period Receives: Other: Microscopic examination using H&E stained slides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive for endometrioma
Presence of endometrial glands and stroma along with hemosidren pigment under microscopic examination, confirms the diagnosis and the case will be calculated and the related clinical data
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start17 Oct 2020
- Primary completion15 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis Outside PelvisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Hasan, Al-Azhar University
- Investigators
- Abdulkarim Hasan, MD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639063
- Sponsor's protocol ID
- PMS20-11-01
- Status last verified
- Mar 2021
- First submitted
- 17 Nov 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinico-pathological Assessment of Surgically Removed Abdominal Wall Endometriomas
- ClinicalTrials.gov ID
- NCT04639063
- Acronym / sponsor ID
- PMS20-11-01
- Conditions
- Endometriosis Outside Pelvis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 20 Nov 2020 (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.
A retrospective review of all patients who underwent surgery for an anterior abdominal wall mass which confirmed by pathology examination as an endometrioma will be completely performed. The clinical data will be recorded and pathology report diagnosis will be correlated with the clinical data to assess the possible causes of endometrioma in the women treated in our tertiary hospital and the efficacy of the surgical excision.
Detailed description
Our hospital is a tertiary center for performing Cesarean sections, external endometriosis (Endometrioma) is a challenging complication for this operation, many treatment choices are available and the most common is the surgical excision, however recurrence could be seen after the surgical operation. We assess all patients who underwent surgical excision for abdominal wall endometriomas in our hospital by retrieving the medical files and pathology reports to study the possible age group,causes and duration of endometriomas. Also the rate of enodmetriomas among the previously experienced females with cesarean section operations. Pathological diagnosis tools will be also assessed.
Ethical approval was obtained from the local committee. Results will be statistically assessed using SPSS programm.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cesarean sectioned | – | –All females who treated in our hospital by Cesarean section operation during two-years-period |
| Complicated with Abdominal wall endometriosis | – | Other: Microscopic examination using H&E stained slidesAll the surgically excised endometrioma cases during the same time period |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients treated in our hospital and pathologically examined in our hospital
Key inclusion criteria (2 listed)
- Female
- Surgically removed abdominal wall endometrioma
Key exclusion criteria (3 listed)
- Male (very very rare to occur)
- medically treated enodmetrioma
- Outside treated patients
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 |
|---|---|---|
| Microscopic examination using H&E stained slidesAlso: CD10 immunohistochemistryReexamination of the stained slides of the patients from the hospital archive and adding a CD10 stain when required | Other | Complicated with Abdominal wall endometriosis |
Primary outcome
Positive for endometrioma
Time frame: 1 day
Presence of endometrial glands and stroma along with hemosidren pigment under microscopic examination, confirms the diagnosis and the case will be calculated and the related clinical data
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 10 Mar 2021.
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.
Abdulkarim Hasan, MD principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis Outside Pelvis, run by Al-Azhar University at 1 site in Egypt.
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 2 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 10 Mar 2021. 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 Egypt. 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?
Positive for endometrioma (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2021.