UMIN-CTR Clinical Trial

Basic information
Public title	The Comprehensive Multi Center Survey on Sexual Dysfunction following Conventional Laparoscopic and Modern Minimally Invasive Approaches for Rectal Cancer (the LANDMARC Study)
Acronym	the LANDMARC Study
Scientific Title	The Comprehensive Multi Center Survey on Sexual Dysfunction following Conventional Laparoscopic and Modern Minimally Invasive Approaches for Rectal Cancer (the LANDMARC Study)
Scientific Title:Acronym	the LANDMARC Study
Region	Japan

Condition
Condition	Rectal Cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish the landmark data regarding the sexual dysfunction following the minimally invasive approaches for rectal cancer incluging laparoscopic, robotic, and transanal lapsroscopic cohort (Lap-TME & Ro-TME & taTME).
Basic objectives2	Others
Basic objectives -Others	To clarify the difference in the rate of sexual dysfunction between 3 approaches (Lap-TME vs Ro-TME vs taTME).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of sexual dysfunction after surgery including 3 approaches (Lap-TME & Ro-TME & taTME)
Key secondary outcomes	The comparison of the rate of sexual dysfunction after surgery between 3 approaches (Lap-TME vs Ro-TME vs taTME)

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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male
Key inclusion criteria	Primary rectal adenocarcinoma Male Performance Status:0-1 Tumor location: Middle and lower rectum Age:20-70 years old Plannded surgery: Lap-TME/ Ro-TME/ taTME
Key exclusion criteria	Previous medication for sexual dysfunction Planned surgery with resection of autonomic nervous system Previous history for any malignancy in the pelivic organ cStage IV
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Rino
Organization	Yokohama City Univercity
Division name	Department of Surgery
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-787-2645
Email	rino@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Masakatsu Middle name Last name Numata
Organization	Yokohama City Univercity
Division name	Department of Surgery
Zip code	2360004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-787-2645
Homepage URL
Email	masakatsunumata@hotmail.co.jp

Sponsor
Institute	Yokohama City University, Department of Surgery
Institute
Department

Funding Source
Organization	Other
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japan Society of Laparoscopic Colorectal Surgery
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel	81-45-787-2800
Email	nextjim1@yokohama-cu.ac.jp

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	2019 Year 07 Month 13 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	Open public recruiting
Date of protocol fixation	2019 Year 07 Month 13 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2026 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 07 Month 13 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042604