UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004017
Receipt No. R000004829
Scientific Title The role of diverting stoma in low anterior resection for rectal cancer -A prospective multicenter study.
Date of disclosure of the study information 2010/08/09
Last modified on 2019/05/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The role of diverting stoma in low anterior resection for rectal cancer
-A prospective multicenter study.
Acronym Diverting stoma in low rectal cancer surgery.
Scientific Title The role of diverting stoma in low anterior resection for rectal cancer
-A prospective multicenter study.
Scientific Title:Acronym Diverting stoma in low rectal cancer surgery.
Region
Japan

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

Objectives
Narrative objectives1 To assess the rate of anastastomotic leakage in patients with or without diverting stoma afte low anterior resection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary outcome are to investigate the rate of anastomotic leak including radiological leak at discharge in low rectal cancer patients undergoing low anterior resection with or without diverting stoma, and to evaluate the need for diverting stoma in patients undergoing low anterior resection.
Key secondary outcomes Risk factors related to anastomotic leakage

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

Not applicable
Gender Male and Female
Key inclusion criteria Preoperative inclusion criteria are biopsy proven adenocarcinoma of the rectum located at within 10cm above the anal verge measured with a rectoscope and/or digital examination, informed consent, ability to understand the study information, and initial operation for rectal cancer excluding local excision.
Intraoperative inclusion is patients undergoing low anterior resection with mechanical anastomosis.
Preoperative radiotherapy, chemotherapy, and laparoscopic surgery are at the choice of the surgeon.
Key exclusion criteria Exclusion criteria are anastomosis with hand sewn technique, emergency operation, and no ability to understand the study information.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Norio
Middle name
Last name Saito
Organization National Cancer Center Hospital East
Division name Colorectal Surgery
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa 277-8577, Japan
TEL +81-4-733-1111
Email norsaito@east.ncc.go.jp

Public contact
Name of contact person
1st name Akio
Middle name
Last name Shiomi
Organization Shizuoka Cancer Center
Division name Colon and Rectal Surgery
Zip code 411-8777
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL +81-55-989-5222
Homepage URL
Email a.shiomi@scchr.jp

Sponsor
Institute Japanese Society for Cancer of the Colon and Rectum
Institute
Department

Funding Source
Organization Japanese Society for Cancer of the Colon and Rectum(JSCCR)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization National Cancer Center Hospital East Certified Review Board
Address 6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan
Tel 04-7133-1111
Email ncche-irb@east.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 愛知県がんセンター中央病院(愛知県)
青森県立中央病院・がん診療センター(青森県)
石川県立中央病院(石川県)
岩手医科大学(岩手県)
大阪医科大学(大阪府)
大阪府立成人病センター(大阪府)
がん・感染症センター都立駒込病院(東京都)
癌研有明病院(東京都)
北里大学(神奈川県)
京都府立医科大学(京都府)
久留米大学(福岡県)
恵佑会札幌病院(北海道)
高知医療センター(高知県)
国立がん研究センター中央病院(東京都)
国立がん研究センター東病院
国立病院機構九州がんセンター(福岡県)
国立病院機構四国がんセンター(愛媛県)
札幌厚生病院(北海道)
静岡県立静岡がんセンター(静岡県)
自治医科大学(栃木県)
東京医科歯科大学(東京都)
東京女子医科大学(東京都)
新潟県立がんセンター新潟病院(新潟県)
兵庫医科大学(兵庫県)
藤田保健衛生大学(愛知県)
防衛医科大学校(埼玉県)
山形県立中央病院(山形県)
横浜市立大学附属市民総合医療センター(神奈川県)
和歌山県立医科大学(和歌山県)
福山市民病院(広島県)
東邦大学医療センター大橋病院(東京都)
大阪赤十字病院(大阪府)
横浜市立みなと赤十字病院(神奈川県)
京都大学(京都府)
順天堂大学(東京都)
埼玉県立がんセンター(埼玉県)
神奈川県がんセンター(神奈川県)
千葉県がんセンター(千葉県)
横浜市南部病院(神奈川県)
杏林大学(東京都)
広島市立安佐市民病院
広島市立広島市民病院

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 09 Day

Related information
URL releasing protocol http://dx.doi.org/10.1016/j.jamcollsurg.2014.10.017
Publication of results Unpublished

Result
URL related to results and publications http://dx.doi.org/10.1016/j.jamcollsurg.2014.10.017
Number of participants that the trial has enrolled 1014
Results
1014 consecutive patients with rectal cancer within 10 cm from the anal verge were investigated in this prospective, multicenter, cohort study. 
Diverting Stoma (DS) did not have a significant relationship with symptomatic anastomotic leakage before and after propensity score matching analysis which was used to compare the group of patients receiving a DS or not. 
Results date posted
2019 Year 05 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with primary rectal cancer in which the lower edge of the tumor was within 10 cm from the anal verge were eligible for this study. For inclusion for this study, patients had to fulfill the following requirements preoperatively: age over 20 years; rectal adenocarcinoma proven on preoperative pathological examination; no multiple rectal lesions other than carcinoma in situ; and LAR with anastomosis using a circular stapler was performed. Exclusion criteria were a history of major colorectal surgery and emergency operation because of bowel obstruction. Preoperative tumor staging was done by digital examination, anoscopy, computed tomography (CT), magnetic resonance imaging (MRI), barium enema, and colonoscopy examination.
Participant flow
Eligible patients were registered preoperatively by sending the registration form to the Data Center in Shizuoka Cancer Center Hospital after confirmation of the inclusion/exclusion criteria.
Participant underwent LAR with construction using a circular stapler.
Adverse events
The overall rate of symptomatic AL (grade B/C) was 12.9% (121/936). 
Outcome measures
Sex,Age,BMI,Tumor size,Tumor location,Tumor invasion,Regional lymph node,Distant metastasis,Bowel obstruction,Neoadjuvant Tx,Operating time,Intraoperative bleeding,Intraoperative bleeding,LLND,Splenic flexure mobilization,Simultaneous resection,Types of surgical procedure,Types of anastomosis,Types of reconstruction,Number of firing,Anastomotic ring,Leakage test,Anastomotic level from AV,Intraluminal drainage,Diverting Stoma	
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 08 Day
Date of IRB
2010 Year 05 Month 28 Day
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The role of diverting stoma in low anterior resection for rectal cancer
- A prospective study in Japanese multicenter.

Management information
Registered date
2010 Year 08 Month 09 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004829

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.