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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05702099
Other study ID # GOKAEK/2017-577
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 18, 2017
Est. completion date September 30, 2022

Study information

Verified date January 2023
Source Bagcilar Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date September 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers
Gender Female
Age group 15 Years to 63 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Bagcilar Teaching and Research Hospital Istanbul Bagcilar

Sponsors (1)

Lead Sponsor Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 × p/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
Primary 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
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