Postoperative Results of Incisional Endometriosis

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03900507

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Pain	Procedure: endometriosis surgery

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Postoperative Results of Patients Who Received Medical Treatment for Incisional Endometriosis and Did Not Respond to Treatment

Actual Study Start Date :

Jun 1, 2018

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Outcome Measures

Primary Outcome Measures

preoperative pain scores [1 week]
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.
postoperative pain scores [1 week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul		Turkey	33404

Sponsors and Collaborators

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pınar Kadirogulları, Principal investigator, M.D, Department of Obstetrics and GynecologyR, Kanuni Sultan Suleyman Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03900507

Other Study ID Numbers:

2018.11.44

First Posted:

Apr 3, 2019

Last Update Posted:

Jul 16, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pınar Kadirogulları, Principal investigator, M.D, Department of Obstetrics and GynecologyR, Kanuni Sultan Suleyman Training and Research Hospital

incisional endometriosis

scar endometriosis

Additional relevant MeSH terms:

Endometriosis

Study Results

No Results Posted as of Jul 16, 2019