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

Ovarian Torsion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05702099
• Other study ID #: GOKAEK/2017-577
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Ovarian Torsion

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