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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032654
Receipt No. R000037233
Scientific Title Indocyanine green fluorescence imaging to reduce the risk of anastomotic leakage in laparoscopic low anterior resection for rectal cancer: A Large, Multicenter, Propensity Score Matched Cohort Study
Date of disclosure of the study information 2018/05/21
Last modified on 2018/05/21

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Basic information
Public title Indocyanine green fluorescence imaging to reduce the risk of anastomotic leakage in laparoscopic low anterior resection for rectal cancer: A Large, Multicenter, Propensity Score Matched Cohort Study
Acronym Fluorescence imaging in laparoscopic low anterior resection
Scientific Title Indocyanine green fluorescence imaging to reduce the risk of anastomotic leakage in laparoscopic low anterior resection for rectal cancer: A Large, Multicenter, Propensity Score Matched Cohort Study
Scientific Title:Acronym Fluorescence imaging in laparoscopic low anterior resection
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to evaluate the effect of ICG fluorescence imaging (ICG-FI) on AL rates during laparoscopic low anterior resection (LAR) for rectal cancer, compared to a propensity score matched series of laparoscopic LAR performed without ICG-FI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint of this study was the rate of AL within 30 days after surgery.
Key secondary outcomes Secondary endpoints were operative time, blood loss, postoperative complications, reoperation within 30 days after surgery, length of hospital stays, oncological clearance, and the rate of changing the surgical plan.

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 Eligibility criteria were 1) rectal cancer located within 15 cm from anal verge with histologically proven adenocarcinoma or signet-ring cell carcinoma and 2) having undergone primary rectal cancer resection.
Key exclusion criteria The exclusion criteria were 1) multiple primary cancers, 2) a history of treatment for other pelvic malignancy, 3) open or robotic surgery cases, and 4) emergent cases.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Watanabe
Organization Yokohama City University Medical Center, Yokohama, Japan
Division name Department of Surgery, Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024. Japan
TEL 045-261-5656
Email nabe-jun@comet.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Watanabe
Organization Yokohama City University Medical Center, Yokohama, Japan
Division name Department of Surgery, Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024. Japan
TEL 045-261-5656
Homepage URL
Email nabe-jun@comet.ocn.ne.jp

Sponsor
Institute Yokohama City University Medical Center, Yokohama, Japan
Institute
Department

Funding Source
Organization Self funding
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
2018 Year 05 Month 21 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 No longer recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This retrospective multi-institutional study was conducted to evaluate the AL rates after laparoscopic LAR for rectal cancer at three institutions of Yokohama Clinical Oncology Group in Japan from September 2014 to December 2017. The study protocol was approved by the Ethical Advisory Committee of Yokohama City University Medical Center and the institutional review board of each participating hospital before the study was initiated. Patient data were collected from clinical report forms. Eligibility criteria were 1) rectal cancer located within 15 cm from anal verge with histologically proven adenocarcinoma or signet-ring cell carcinoma and 2) having undergone primary rectal cancer resection. The exclusion criteria were 1) multiple primary cancers, 2) a history of treatment for other pelvic malignancy, 3) open or robotic surgery cases, and 4) emergent cases.
The primary endpoint of this study was the rate of AL within 30 days after surgery. Secondary endpoints were operative time, blood loss, postoperative complications, reoperation within 30 days after surgery, length of hospital stays, oncological clearance, and the rate of changing the surgical plan.

Management information
Registered date
2018 Year 05 Month 21 Day
Last modified on
2018 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037233

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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