UMIN-CTR Clinical Trial

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

Rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japanese Society for Cancer of the Colon and Rectum

Institute

Department

Personal name

Organization

Japanese Society for Cancer of the Colon and Rectum(JSCCR)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2010

Year

08

Month

09

Day

URL releasing protocol

http://dx.doi.org/10.1016/j.jamcollsurg.2014.10.017

Publication of results

Unpublished

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

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 related information

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

Registered date

2010

Year

08

Month

09

Day

Last modified on

2019

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004829