UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047818 |
|---|---|
| Receipt number | R000054517 |
| Scientific Title | A Multicenter Randomized Controlled Trial Comparing Stapled and Hand-sewn Anastomosis in Intersphincteric Resection with Transanal Total Mesorectal Excision |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2022/05/20 20:19:30 |
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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
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
dkitaguc@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054517
