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A Multicentre Study to Examine the Short and Long Term Outcomes of the Conservative Management of Benign-looking Adnexal Masses and the Pre-operative Characterisation of Ovarian Tumours


N/A
18 Years
N/A
Open (Enrolling by invite only)
Female
Adnexal Masses, Ovarian Cysts, Ovarian Tumors

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Trial Information

A Multicentre Study to Examine the Short and Long Term Outcomes of the Conservative Management of Benign-looking Adnexal Masses and the Pre-operative Characterisation of Ovarian Tumours


Inclusion Criteria:



- Any woman at least 18 years old with an adnexal mass.

- Any mass with benign ultrasound morphology may be suitable for conservative
management.

- Pregnant patients can be included, but their data will be analysed separately.

Exclusion Criteria:

- Cysts that are deemed to be clearly physiological and less than 3 cm in maximum
diameter are not eligible for inclusion.

- Any cyst with features of malignancy is excluded from the conservative management

- The denial or withdrawal of oral informed consent

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses

Outcome Time Frame:

Up to five years

Safety Issue:

Yes

Principal Investigator

Lauri Hochberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida

Authority:

United States: Institutional Review Board

Study ID:

USF IRB Pro00009001

NCT ID:

NCT01698632

Start Date:

September 2012

Completion Date:

September 2018

Related Keywords:

  • Adnexal Masses
  • Ovarian Cysts
  • Ovarian Tumors
  • Adnexal masses
  • Ovarian cysts
  • Ovarian tumors
  • Ovarian Neoplasms
  • Ovarian Cysts

Name

Location
USF Health South Tampa Center for Advanced Healthcare Tampa, Florida  33606