Effect of Simultaneous Cystectomy on Ovarian Reserve in Cases of Adnexal Detorsion

NCT ID: NCT05702099

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-18

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There are mostly ovarian cysts under adnexal torsion from gynecological emergencies. There are many studies in the literature examining the effect of adnexal detorsion on ovarian reserve. However, there is no study in the literature examining the effect of concomitant cystectomy. In this study, the investigators aimed to investigate whether the cystectomy procedure performed together with detorsion has an additional effect on the ovarian reserve in cases of ovarian torsion with cysts.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All women who underwent emergency surgery in the investigators' obstetrics and gynecology department since April 2015 due to adnexal torsion were analyzed. All patients who underwent ovarian detorsion (Group 1) and ovarian detorsion+cystectomy (Group 2) were called for control between 6-12 months postoperatively. In all patients, the sizes of both ovaries and the number of antral follicles were counted by ultrasonography by 2 physicians who did not know the detorsion side beforehand. All women will be compared within and between groups in terms of ovarian sizes and antral follicle numbers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Torsion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Detorsion

The group in which only adnexal detorsion was performed during the operation (Because there is no ovarian mass)

ultrasonography

Intervention Type DIAGNOSTIC_TEST

By performing transvaginal or transabdominal ultrasonography on women, ovarian volume will be calculated and antral follicle will be counted.

Detorsion+cystectomy

Women with an ovarian mass who underwent emergency surgery for torsion, who underwent both detorsion and cystectomy in the same session.

ultrasonography

Intervention Type DIAGNOSTIC_TEST

By performing transvaginal or transabdominal ultrasonography on women, ovarian volume will be calculated and antral follicle will be counted.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ultrasonography

By performing transvaginal or transabdominal ultrasonography on women, ovarian volume will be calculated and antral follicle will be counted.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All women who underwent emergency surgery for ovarian torsion

Exclusion Criteria

* Those who underwent oophorectomy with suspicion of malignancy
* When faced with spontaneously amputated ovary due to chronic or acute torsion
* Women with only salpinx torsion
Minimum Eligible Age

15 Years

Maximum Eligible Age

63 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Evrim Ebru Kovalak

Principal investigator, Doctor, Gynecology and obstetrics specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Evrim Ebru Kovalak

Role: PRINCIPAL_INVESTIGATOR

Bagcilar Training and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Bozdag G, Demir B, Calis PT, Zengin D, Dilbaz B. The impact of adnexal torsion on antral follicle count when compared with contralateral ovary. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):632-5. doi: 10.1016/j.jmig.2014.01.007. Epub 2014 Jan 21.

Reference Type RESULT
PMID: 24462592 (View on PubMed)

Calis P, Bozdag G, Karakoc Sokmensuer L, Kender N. Does ischemia-reperfusion injury affect ovarian reserve and follicle viability in a rat model with adnexal torsion? Eur J Obstet Gynecol Reprod Biol. 2015 Feb;185:126-30. doi: 10.1016/j.ejogrb.2014.12.006. Epub 2014 Dec 23.

Reference Type RESULT
PMID: 25575140 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GOKAEK/2017-577

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.