UMIN-CTR Clinical Trial

Basic information
Public title	Histological findings after hysterectomy
Acronym	REHH
Scientific Title	Retrospective evaluation of histological findings after hysterectomy
Scientific Title:Acronym	REHH
Region	Europe

Condition
Condition	Histology is a key aspect to detect diseases that were conceiled before surgery
Classification by specialty	Medicine in general Surgery in general Obsterics and gynecology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The study aims at detecting diseases that were not pre-operatively recognized
Basic objectives2	Others
Basic objectives -Others	Definition of prevalence of adenomyosis in the general population and its association with other diseases
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of adenomyosis in the general population during a 5 years span
Key secondary outcomes	Association between adenomyosis and other uterine disease like cancer, myomas, and fibromatosis

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Female
Key inclusion criteria	Patients who underwent hysterectomy
Key exclusion criteria	None
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Marco Middle name Last name Scioscia
Organization	Policlinico Hospital of Abano Terme, Padua, Italy
Division name	Dpt Obstetrics and Gynecology
Zip code	35031
Address	Piazza Cristoforo Colombo 1
TEL	00393498724206
Email	marcoscioscia@gmail.com

Public contact
Name of contact person	1st name Marco Middle name Last name Scioscia
Organization	Policlinico Hospital of Abano Terme, Padua, Italy
Division name	Dpt Obstetrics and Gynecology
Zip code	35031
Address	Piazza Cristoforo Colombo 1
TEL	00393498724206
Homepage URL
Email	marcoscioscia@gmail.com

Sponsor
Institute	Arcispedale Sant'Anna Via Aldo Moro 8 Cona, Ferrara Italy
Institute
Department

Funding Source
Organization	Arcispedale Sant'Anna Via Aldo Moro 8 Cona, Ferrara Italy
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Arcispedale Sant'Anna
Address	Via Moro 8
Tel	00393339194792
Email	grcptl@unife.it

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	University Hospital

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 05 Month 04 Day
Date of IRB
Anticipated trial start date	2020 Year 05 Month 04 Day
Last follow-up date	2020 Year 05 Month 28 Day
Date of closure to data entry	2020 Year 06 Month 07 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective re-evaluation of histological findings after hysterectomy.

Management information
Registered date	2020 Year 05 Month 28 Day
Last modified on	2020 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046301