NCT04639063

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

November 17, 2020

Last Update Submit

March 9, 2021

Conditions

Endometriosis Outside Pelvis

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Study Arms (2)

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

Other: Microscopic examination using H&E stained slides

Interventions

Microscopic examination using H&E stained slidesOTHER

Reexamination of the stained slides of the patients from the hospital archive and adding a CD10 stain when required

Also known as: CD10 immunohistochemistry
Complicated with Abdominal wall endometriosis

Eligibility Criteria

Age15 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients treated in our hospital and pathologically examined in our hospital

You may qualify if:

  • Female
  • Surgically removed abdominal wall endometrioma

You may not qualify if:

  • Male (very very rare to occur)
  • medically treated enodmetrioma
  • Outside treated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdulkarim Hasan

Cairo, 11884, Egypt

Location

Study Officials

  • Abdulkarim Hasan, MD

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pathologist and Laboratory Director

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 20, 2020

Study Start

October 17, 2020

Primary Completion

December 15, 2020

Study Completion

December 20, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

EG(1)