UMIN-CTR Clinical Trial

Basic information
Public title	Research on surgical anastomosis of the rectum
Acronym	Super SST Trial
Scientific Title	A Multicenter Randomized Controlled Trial Comparing Stapled and Hand-sewn Anastomosis in Intersphincteric Resection with Transanal Total Mesorectal Excision
Scientific Title:Acronym	Super SST Trial
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare short-term and anorectal functional outcomes between stapled and hand-sewn anastomosis in ISR with TaTME.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anastomosis-related complications within 30 days after surgery
Key secondary outcomes	operation time; reoperation; mortality; length of postoperative hospital stay; readmission; incidence of anal pain and rectal mucosal prolapse; length of temporary stoma retention; the proportion of patients with a temporary stoma at 1 year after surgery; anorectal function at 1 year after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Group A: Hand-sewn anastomosis
Interventions/Control_2	Group B: Stapled anastomosis
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients aged between 20 and 80 years old who are scheduled to undergo ISR with TaTME for rectal cancer located within 6cm from the anal verge (AV) will be included.
Key exclusion criteria	Emergent surgery, two or more anastomosis in the same surgery, poorly controlled diabetes mellitus, and cases deemed unsuitable by the doctor in charge, will result in exclusion.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Ito
Organization	National Cancer Center Hospital East
Division name	Department of Colorectal Surgery
Zip code	277-857
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	0471331111
Email	maito@east.ncc.go.jp

Public contact
Name of contact person	1st name Daichi Middle name Last name Kitaguchi
Organization	National Cancer Center Hospital East
Division name	Department of Colorectal Surgery
Zip code	277-857
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL	0471331111
Homepage URL
Email	dkitaguc@east.ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	the institutional research ethics review board of the National Cancer Center Hospital
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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	2022 Year 05 Month 31 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	2022 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 20 Day
Last modified on	2022 Year 05 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054517