UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008302
Receipt number R000009655
Scientific Title A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection
Date of disclosure of the study information 2012/06/29
Last modified on 2017/01/05 08:40:17

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Basic information

Public title

A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection

Acronym

A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection

Scientific Title

A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection

Scientific Title:Acronym

A single-arm prospective observational study of the Safety and Performance of the DST using Tri-Staple in Laparoscopic left colectomy and rectal resection

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and safety of Endo GIA Tri-Staple in laparoscopic left colectomy and rectal resection with DST anastomosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of staples used and the condition on rectal stump

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Endo GIA Tri-Staple

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

1) 20 years old or older (no upper limit)
2) Patients scheduled for DST anastomosis after laparoscopic left colectomy or rectal resection.
3) No history of abdominal surgery(except appendectomy)
4) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1
5) Healthy organ function
6) Written informed consent is obtained from the patient him/herself

Key exclusion criteria

1) laparoscopic surgery under reduced port surgery
2) Patients having pregnant, nursing or probability of pregnancy
3) Patients receiving continued systemic (oral or intravenous) steroids
4) tients with uncontrolled diabetes mellitus (HbA1c >8.0%)
5) Patients having allergic reaction to nickel-chromium alloy
6) Judged difficulty due to study complications related to a psychiatric disorder or psychological symptoms
7) Judged unsuitable patient for study participation by the investigator for any other reason

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotoshi Hasegawa, M.D.

Organization

Keio University School of Medicine

Division name

Keio University School of Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Koji Okabayashi

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address


TEL

03-3353-1211

Homepage URL


Email



Sponsor or person

Institute

Keio University School of Medicine, Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

Covidien Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

2012 Year 06 Month 29 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

2011 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 06 Month 29 Day

Last modified on

2017 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009655


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name