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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03900507
Other study ID # 2018.11.44
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary aim is to determine the endometriotic foci formed in the incision line after surgical operations, and the medical treatment approach is the primary objective. Medical treatment was initiated and the patients who did not benefit from the treatment would be operated and postoperative pain scores would be compared with the medical treatment. It will be tried to determine which treatment is more effective in pain control.

In addition to removing the symptoms and providing therapeutic methods in patients, it is aimed to help in differential diagnosis of dermatological diseases and malignancy and thus to prevent anxiety in patients. It is also aimed to evaluate the pathology results in the most appropriate way to eliminate the symptoms (severe pain, bleeding, etc.) that occur in accordance with the menstrual cycle every month.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Patients who have undergone surgery previously and who have an incision in the abdominal region and who applied with a complaint of mass in the incision and who were primarily considered endometrial focus in the diagnosis,

- Patients who were diagnosed with endometriotic foci in the incision line and used medical treatment for a while, but who did not benefit because of surgical excision.

Exclusion Criteria:

- Dermatologically diagnosed patients

- Follow-up patients with malignancy diagnosis

- Patients who have responded to medical treatment

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
endometriosis surgery
Medical treatment was initiated in patients with abdominal incision due to endometriotic focus in the incision line. however, patients with surgical excision indications were the study group.

Locations

Country Name City State
Turkey Kanuni Sultan Süleyman Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary preoperative pain scores The preoperative pain scores of the patients who were planned for operation due to incisional endometriosis and who were more likely to receive medical treatment will be evaluated with visuel visual scale (vas).
vas score '0' no pain; The vas score '10' will be recorded as unbearable pain.
1 week
Primary postoperative pain scores The postoperative pain scores of the patients who were planned for operation due to incisional endometriosis and who were more likely to receive medical treatment will be evaluated with visuel visual scale (vas).
vas score '0' no pain; The vas score '10' will be recorded as unbearable pain.
1 week
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