UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Acronym	Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Scientific Title	Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Scientific Title:Acronym	Comparison of short-term outcomes between pedicled- and free-flap autologous breast reconstruction
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the complications after pedicled- or free-flap breast reconstruction.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the occurrence of postoperative complications
Key secondary outcomes

Base
Study type	Observational

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Using a Japanese national inpatient database, we identified female patients with breast cancer who underwent breast reconstruction using a pedicled flap or free flap between July 2010 and March 2020.
Key exclusion criteria	We excluded patients with stage IV breast cancer because surgery is not a standard treatment for stage IV breast cancer.
Target sample size	13000

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Karakawa Last name Karakawa
Organization	Caner Institute Hospital
Division name	Plastic and Reconstructive Surgery
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku,
TEL	0335200111
Email	ryo.kyara@gmail.com

Public contact
Name of contact person	1st name Ryo Middle name Last name Karakawa
Organization	Caner Institute Hospital
Division name	Plastic and Reconstructive Surgery
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku,
TEL	0335200111
Homepage URL
Email	ryo.kyara@gmail.com

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

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

Other administrative information
Date of disclosure of the study information	2021 Year 12 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	13000
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	Completed
Date of protocol fixation	2021 Year 07 Month 01 Day
Date of IRB	2021 Year 07 Month 01 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2021 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This nationwide retrospective cohort study was performed using the Diagnosis Procedure Combination database, which includes hospital administrative claims data and discharge abstracts of approximately 7,000,000 inpatients in more than 1000 hospitals throughout Japan [26, 27], covering approximately half of all inpatient admissions to acute-care hospitals in Japan. All 82 university hospitals are obliged to participate in the database; participation by community hospitals is voluntary.

Management information
Registered date	2021 Year 12 Month 10 Day
Last modified on	2021 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052879