NCT03900507

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

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

June 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

April 1, 2019

Last Update Submit

July 12, 2019

Conditions

Keywords

incisional endometriosisscar endometriosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • Dermatologically diagnosed patients
  • Follow-up patients with malignancy diagnosis
  • Patients who have responded to medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EndometriosisPain

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, M.D, Department of Obstetrics and GynecologyR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

June 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations