Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis

• Sponsor: Bagcilar Training and Research Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06132009
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Procedure: Surgery of endometriosis

Detailed Description

Endometriosis is an estrogen-dependent gynecological disease characterized by the presence of endometrial-like tissue outside the uterine cavity, associated with pelvic pain and subfertility. Despite its benign character, endometriosis can recur after surgery and continues to be a disease that disrupts the quality of life of millions of women. This study aimed to examine the risk factors in women who underwent cystectomy or unilateral salpingo-oophorectomy due to endometriosis but had a recurrence. Therefore, the predictive value of parameters such as preoperative biochemical parameters, cyst size and the revised American Society for Reproductive Medicine (rASRM) Scoring system will be examined in recurrent cases.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 64 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis
• Actual Study Start Date: Feb 22, 2022
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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; Cystectomy or unilateral oophorectomy due to 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; Cystectomy or unilateral oophorectomy due to endometriosis

Outcome Measures

Primary Outcome Measures

1. Prediction of endometriosis recurrence [6-180 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female

Inclusion Criteria:

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

Exclusion Criteria:

• Women who have had bilateral oophorectomy due to endometriosis

• Malignant conditions

• Smoking

• Women with autoimmune disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bagcilar Teaching and Research Hospital	Istanbul	Bagcilar	Turkey	34200

Sponsors and Collaborators

• Bagcilar Training and Research Hospital

Investigators

• Principal Investigator: Evrim Ebru Kovalak, MD, Bagcilar Training and Research Hospital

Study Documents (Full-Text)

• Informed Consent Form - Dec 1, 2019

More Information

Additional Information:

• 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.

Publications

None provided.

• Responsible Party: Evrim Ebru Kovalak, Medical Doctor, gynecologist, Bagcilar Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT06132009
• Other Study ID Numbers: 2023/05/11/030
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 15, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Evrim Ebru Kovalak, Medical Doctor, gynecologist, Bagcilar Training and Research Hospital: Endometriosis; prevention & control; preoperative procedures
• Additional relevant MeSH terms: Endometriosis

Study Results

No Results Posted as of Nov 15, 2023