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

Sponsor
Bagcilar Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05702099
Collaborator
(none)
67
1
65.4
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasonography

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

Study Type:
Observational
Actual Enrollment :
67 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effect of Simultaneous Cystectomy on Ovarian Reserve in Cases of Adnexal Detorsion
Actual Study Start Date :
Apr 18, 2017
Actual Primary Completion Date :
Aug 30, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Detorsion

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Ovarian volume difference between groups [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.

  2. The number of antral follicles difference between groups [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 63 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bagcilar Teaching and Research Hospital Istanbul Bagcilar Turkey 34200

Sponsors and Collaborators

  • Bagcilar Training and Research Hospital

Investigators

  • Principal Investigator: Evrim Ebru Kovalak, Bagcilar Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evrim Ebru Kovalak, Principal investigator, Doctor, Gynecology and obstetrics specialist, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05702099
Other Study ID Numbers:
  • GOKAEK/2017-577
First Posted:
Jan 27, 2023
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Evrim Ebru Kovalak, Principal investigator, Doctor, Gynecology and obstetrics specialist, Bagcilar Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023