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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01880905
Other study ID # 0031-13-MMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 11, 2013
Last updated June 18, 2013
Start date July 2013
Est. completion date July 2014

Study information

Verified date April 2013
Source Meir Medical Center
Contact Amir Wiser
Phone 97297472227
Email amir.wiser@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

Ovarian torsion is one of the gynecological emergency. This complication requires high clinical suspicion and early detection, to prevent permanent loss of ovarian function. The long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the length between the torsion group and other non torsion patients


Description:

Female patient who are going to undergo laparoscopy/laparotomy for any gynecological reason will ask to participate. During the operation the uteroovarian ligament length will be measure by sterile ruler (calibrated plastic device 1 mm in diameter).

The length of uteroovarian ligament will compared between the patient who will diagnose with ovarian torsion (study group) and the other women (control group)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 45 Years
Eligibility Inclusion Criteria:

- Indication for gynecological operation

- hemodynamically stable

Exclusion Criteria:

- Ovarian torsion in the past

- History of pelvic inflammatory disease (PID)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Procedure:
Measure of uteroovarian ligament length during gynecological surgery


Locations

Country Name City State
Israel Meir Medical Center Kfar Sava

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary uteroovarian ligament length 1 minute No
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