UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001390
Receipt number R000001690
Scientific Title Prospective randomized trial for determination of optimum size of side limb in low anterior resection with side-to-end anastomosis for rectal carcinoma
Date of disclosure of the study information 2008/09/25
Last modified on 2008/09/24 14:11:28

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Basic information

Public title

Prospective randomized trial for determination of optimum size of side limb in low anterior resection with side-to-end anastomosis for rectal carcinoma

Acronym

Optimum size of side limb in low anterior resection with side-to-end anastomosis

Scientific Title

Prospective randomized trial for determination of optimum size of side limb in low anterior resection with side-to-end anastomosis for rectal carcinoma

Scientific Title:Acronym

Optimum size of side limb in low anterior resection with side-to-end anastomosis

Region

Japan


Condition

Condition

prospective randomized trial

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Functional outcome after low anterior resection with side-to-end anastomosis is comparable with colonic J-pouch. Optimum size of the side limb has yet to be determined. Therefore, we initiated a prospective randomized trial using 3 cm side limb (short limb) and 6 cm side limb (long limb) to determine this size.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Functional outcomes after 3 cm side limb (short limb) and 6 cm side limb (long limb)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


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

3 cm side limb

Interventions/Control_2

6 cm side limb

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

patients with middle to low rectal carcinoma

Key exclusion criteria

unresectable tumor

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Tsunoda

Organization

Showa University School of Medicine

Division name

Department of Gastroenterological and General Surgery

Zip code


Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8666 JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Showa University

Division name

School of Medicine

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Gastroenterological and General Surgery

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterological and General Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2008 Year 09 Month 25 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

Completed

Date of protocol fixation

2004 Year 10 Month 13 Day

Date of IRB


Anticipated trial start date

2005 Year 01 Month 01 Day

Last follow-up date

2008 Year 08 Month 01 Day

Date of closure to data entry

2008 Year 08 Month 01 Day

Date trial data considered complete

2008 Year 08 Month 01 Day

Date analysis concluded

2008 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 09 Month 24 Day

Last modified on

2008 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name