NCT05702099

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

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

April 18, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

5.4 years

First QC Date

December 21, 2022

Last Update Submit

January 18, 2023

Conditions

Ovarian Torsion

Keywords

ovarian torsioncystectomyovarian reserve

Outcome Measures

Primary Outcomes (2)

  • Ovarian volume difference between groups

    To analyze whether there is a difference between the ovarian reserve parameters of women who underwent detorsion and detorsion+cystectomy. With ultrasonographic imaging, both ovaries will be evaluated for ovarian volume ( V = length × width × height × π/6) (cm3). Both the affected ovary will be compared with the contralateral ovary and the affected ovaries will be compared between groups.

    postoperative 6-12 months

  • The number of antral follicles difference between groups

    To analyze whether there is a difference between the ovarian reserve parameters of women who underwent detorsion and detorsion+cystectomy. With ultrasonographic imaging, both ovaries will be evaluated for the number of antral follicles. Both the affected ovary will be compared with the contralateral ovary and the affected ovaries will be compared between groups.

    postoperative 6-12 months

Study Arms (2)

Detorsion

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

Diagnostic Test: ultrasonography

Detorsion+cystectomy

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

Diagnostic Test: ultrasonography

Interventions

ultrasonographyDIAGNOSTIC_TEST

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

DetorsionDetorsion+cystectomy

Eligibility Criteria

Age15 Years - 63 Years
Sexfemale(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All women between the ages of 15-63 who underwent emergency surgery for ovarian torsion.

You may qualify if:

  • All women who underwent emergency surgery for ovarian torsion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 24462592RESULT

  • 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.

    PMID: 25575140RESULT

MeSH Terms

Conditions

Ovarian Torsion

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesTorsion AbnormalityPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Evrim Ebru Kovalak

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Doctor, Gynecology and obstetrics specialist

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 27, 2023

Study Start

April 18, 2017

Primary Completion

August 30, 2022

Study Completion

September 30, 2022

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

TU(1)