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CompletedNCT05702099Updated Jan 27, 2023

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

An observational study in Ovarian Torsion, sponsored by Bagcilar Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 15 Years to 63 Years. Per ClinicalTrials.gov, last updated 2023-01-27.

Sponsored by Bagcilar Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
67
Ages
15 Years to 63 Years
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Ovarian Torsion

Keywords

  • ovarian torsion
  • cystectomy
  • ovarian reserve
03

In context

Lead sponsor

Bagcilar Training and Research Hospital is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 63 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • All women who underwent emergency surgery for ovarian torsion

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
67 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testultrasonography

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: postoperative 6-12 months

  2. 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.

    Time frame: postoperative 6-12 months

07

Study locations

1 site
  • Bagcilar Teaching and Research Hospital
    Istanbul, Bagcilar 34200, Turkey
08

References and documents

Publications

  • 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. PubMed 24462592 ↗
  • 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. PubMed 25575140 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05702099
Lead sponsor
Bagcilar Training and Research Hospital
Responsible party
Evrim Ebru Kovalak (Principal investigator, Doctor, Gynecology and obstetrics specialist, Bagcilar Training and Research Hospital) — Principal investigator
First posted
Jan 27, 2023
Start date
Apr 18, 2017
Primary completion
Aug 30, 2022
Completion
Sep 30, 2022
Last update
Jan 27, 2023

Study contacts

Evrim Ebru Kovalak
principal investigator · Bagcilar Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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