NCT01659489

Brief Summary

Adnexal torsion , is a severe, though uncommon gynecological emergency, with a prevalence of 2.7-3%. The need for prompt diagnosis and treatment in order to save ovarian tissue has been realized a long time ago. A marker that will aid in the diagnosis of torsion and prevent missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of unecessary laparoscopic interventions is much needed. To our knowledge, such marker has not been found. The purpose of this study is to find a marker using blood/serum from patients undergoing laparoscopy for suspected ovarian torsion

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

4.3 years

First QC Date

July 31, 2012

Last Update Submit

April 19, 2016

Conditions

Adnexal TorsionLaparoscopy

Keywords

adnexal torsionlaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Serum level of blood proteins (complete list available by direct contact)will be measured before and after ovarian detorsion, and will be compared to those taken from patients who were underwent diagnostic laparoscopy for suspected ovarian torsion.

    Blood will be withrawed before and within 12 hourse after the surgery. The results will be analysed after recruitment and blood withrawal is finished. not later than three years after the begining of the trial

Study Arms (1)

women undergoing laproscopy fo rsuspected adnexal torsion

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

200 women undergoing laparoscopy for suspected ovarian torsion in a tertiary referral center

You may qualify if:

  • women undergoing laparoscopy for suspected ovarian torsion

You may not qualify if:

  • elevated liver enzymes
  • suspected ovarian malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The chaim sheba medical center,Tel Hashomer

Ramat Gan, 52503, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be frozen for evaluation

MeSH Terms

Conditions

Ovarian Torsion

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesTorsion AbnormalityPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 7, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

IL(1)