Ovarian TorsionNCT05702099
Effect of Simultaneous Cystectomy on Ovarian Reserve in Cases of Adnexal Detorsion
An observational study of Ovarian Torsion, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 15 to 63 years, women only
- Conditions the study is for
- Ovarian Torsion
- What is being tested?
- ultrasonography
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2017to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 63 years
- Women only
- Child, Adult
Study population: All women between the ages of 15-63 who underwent emergency surgery for ovarian torsion.
Who may be able to join
- All women who underwent emergency surgery for ovarian torsion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Teaching and Research Hospital
Istanbul, Bagcilar, 34200
About this study
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.
- Conditions
- Ovarian Torsion
- Being tested
- ultrasonography
- Keywords
- ovarian torsion, cystectomy, ovarian reserve
- Medical subject headings
- Ovarian Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDiagnostic test
By performing transvaginal or transabdominal ultrasonography on women, ovarian volume will be calculated and antral follicle will be counted.
| Study group | Role | What they receive |
|---|---|---|
| Detorsion | The group in which only adnexal detorsion was performed during the operation (Because there is no ovarian mass) Receives: 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. Receives: Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: postoperative 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start18 Apr 2017
- Primary completion30 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian TorsionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Evrim Ebru Kovalak, Bagcilar Training and Research Hospital
- Investigators
- Evrim Ebru Kovalak, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702099
- Sponsor's protocol ID
- GOKAEK/2017-577
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 24462592Calis 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simultaneous Cystectomy on Ovarian Reserve in Cases of Adnexal Detorsion
- ClinicalTrials.gov ID
- NCT05702099
- Acronym / sponsor ID
- GOKAEK/2017-577
- Conditions
- Ovarian Torsion
- Keywords
- ovarian torsion, cystectomy, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Detorsion | – | Diagnostic Test: ultrasonographyThe group in which only adnexal detorsion was performed during the operation (Because there is no ovarian mass) |
| Detorsion+cystectomy | – | Diagnostic Test: ultrasonographyWomen with an ovarian mass who underwent emergency surgery for torsion, who underwent both detorsion and cystectomy in the same session. |
Who may qualify
- Ages
- 15 to 63 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- All women between the ages of 15-63 who underwent emergency surgery for ovarian torsion.
Key inclusion criteria (1 listed)
- All women who underwent emergency surgery for ovarian torsion
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographyBy performing transvaginal or transabdominal ultrasonography on women, ovarian volume will be calculated and antral follicle will be counted. | Diagnostic test | Detorsion, Detorsion+cystectomy |
Primary outcome
Ovarian volume difference between groups
Time frame: postoperative 6-12 months
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.
The number of antral follicles difference between groups
Time frame: postoperative 6-12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Results publication: PubMed 24462592Bozdag 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.
- Results publication: PubMed 25575140Calis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Ebru Kovalak principal investigator
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Torsion, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian volume difference between groups (time frame: postoperative 6-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.