NCT06132009

Brief Summary

To investigate the effect of preoperative evaluation parameters in predicting recurrent disease in women who have undergone cystectomy or unilateral salpingo-oophorectomy due to endometriosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

November 7, 2023

Last Update Submit

November 13, 2023

Conditions

Keywords

Endometriosisprevention & controlpreoperative procedures

Outcome Measures

Primary Outcomes (1)

  • Prediction of endometriosis recurrence

    Which women are more likely to have recurrence after endometriosis surgery?

    6-180 months

Study Arms (2)

Remission group

Group of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but were in remission during follow-up

Procedure: Surgery of endometriosis

Recurrent group

Group of women who underwent cystectomy or unilateral oophorectomy due to endometriosis but developed an endometrioma of at least 2 cm in size in a single ovary during follow-up.

Procedure: Surgery of endometriosis

Interventions

Cystectomy or unilateral oophorectomy due to endometriosis

Recurrent groupRemission group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All women between the ages of 18-50 who were followed up in our clinic after cystectomy or unilateral oophorectomy due to endometriosis.

You may qualify if:

  • Women aged 18-50 who had a cystectomy or unilateral oophorectomy due to endometriosis

You may not qualify if:

  • Women who have had bilateral oophorectomy due to endometriosis
  • Malignant conditions
  • Smoking
  • Women with autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Hidari T, Hirata T, Arakawa T, Koga K, Neriishi K, Fukuda S, Nakazawa A, Nagashima N, Ma S, Sun H, Takamura M, Harada M, Hirota Y, Wada-Hiraike O, Fujii T, Osuga Y. Contralateral ovarian endometrioma recurrence after unilateral salpingo-oophorectomy. BMC Womens Health. 2019 May 2;19(1):59. doi: 10.1186/s12905-019-0760-z.

Related Links

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Evrim Ebru Kovalak, MD

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evrim Ebru Kovalak, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, gynecologist

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 15, 2023

Study Start

February 22, 2022

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations