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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040645
Receipt No. R000046233
Scientific Title The Study investigating the Impact of Endoscopic Surgical Skill Qualification in Laparoscopic Resection for Rectal Cancer in Japan
Date of disclosure of the study information 2020/06/03
Last modified on 2020/12/17

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Basic information
Public title The Study investigating the Impact of Endoscopic Surgical Skill Qualification in Laparoscopic Resection for Rectal Cancer in Japan
Acronym EnSSURE study
Scientific Title The Study investigating the Impact of Endoscopic Surgical Skill Qualification in Laparoscopic Resection for Rectal Cancer in Japan
Scientific Title:Acronym EnSSURE study
Region
Japan

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

Objectives
Narrative objectives1 The present study aims to evaluate the impact of the Endoscopic Surgical Skill Qualification on the safety and oncological outcomes of laparoscopic rectal resections for rectal cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative complication rate (Clavien-DIndo classification Grade 3 or above)
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 Male and Female
Key inclusion criteria The cases who underwent elective laparoscopic rectal resections for rectal cancer from January 2010 to December 2013 in the institutions enrolled to the Japan Society of Laparoscopic Colorectal Surgery were retrospectively reviewed. The inclusion criteria for this study specified histologically confirmed adenocarcinoma of the rectal tumor located in RS, Ra or Rb. The tumor had to be StageII to StageIII as preoperatively assessment.
Key exclusion criteria Patients who had other synchronous or metachronous cancers (excluding in situ cancer) within 5 years and received chemotherapy/radiotherapy prior to surgery were excluded.
The cases performed by robotic surgery or cases of colitic cancer were also excluded.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Akinobu
Middle name
Last name Taketomi
Organization Graduate school of Medicine, Hokkaido University
Division name Department of Gastroenterological Surgery 1
Zip code 060-8638
Address N-15, W-7, Kita-ku, Sapporo
TEL 011-706-5927
Email taketomi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Nobuki
Middle name
Last name Ichikawa
Organization Graduate school of Medicine, Hokkaido University
Division name Department of Gastroenterological Surgery 1
Zip code 060-8638
Address N-15, W-7, Kita-ku, Sapporo
TEL 011-706-5927
Homepage URL
Email n_ichi@d5.dion.ne.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery 1, Graduate School of Medicine, Hokkaido University
Organization
Division
Category of Funding Organization Self funding
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 Hokkaido University Hospital
Address N-14, W-5, Kita-ku,Sapporo
Tel 011-706-7061
Email n_ichi@d5.dion.ne.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
2020 Year 06 Month 03 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
2020 Year 03 Month 01 Day
Date of IRB
2020 Year 03 Month 12 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This cohort study investigates the short- and long-term postoperative outcomes of laparoscopic procedures for rectal cancer performed by or with qualified surgeons compared with outcomes for unqualified surgeons.

Management information
Registered date
2020 Year 06 Month 03 Day
Last modified on
2020 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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