Comparison of the amount of identified lymph nodes involved in the resected sample of rectal cancer before and after injection of methylene blue in the main artery of the sample
Determining the average number of identified lymph nodes involved in the resected sample of rectal cancer by injecting methylene blue in the main artery of the sample
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 63 patients. A block method was used for randomization.
Settings and conduct
This study was designed and implemented in Imam Khomeini Sari Medical Education Center affiliated with Mazandaran University of Medical Sciences as a randomized clinical trial with a double-blind control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria was age between 18 to 80 and rectum cancer.
Exclusion criteria was Massive and invasive tumors that require a special technique for resection, neoadjuvant therapy, metastasis and inflammatory bowel disease.
Intervention groups
The inferior mesenteric arteries of 33 specimens were cannulated with a standard 17–20-G iv-catheter by the surgeon who is using this technique in order to check the integrity of the total mesorectal dissection. After that, the arteries were filled with 30 ml of methylene blue solution (15 mg diluted with 0.9% saline; ratio 1:1).and then specimen refer to pathology laboratory.
Main outcome variables
Determining the average number of identified lymph nodes involved in the resected sample of rectal cancer by injecting methylene blue in the main artery of the sample
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059096N2
Registration date:2024-02-17, 1402/11/28
Registration timing:retrospective
Last update:2024-02-17, 1402/11/28
Update count:0
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Mohammad Javad Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 223 5772
Email address
mjnajafi@rocketmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2019-03-20, 1397/12/29
Actual recruitment end date
2021-03-19, 1399/12/29
Trial completion date
2021-04-20, 1400/01/31
Scientific title
Comparison of the amount of identified lymph nodes involved in the resected sample of rectal cancer before and after injection of methylene blue in the main artery of the sample
Public title
Enhancing lymph node detection in rectal specimens: The role of Methylene Blue arterial injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 80
Rectum cancer
Exclusion criteria:
Massive and invasive tumors that require a special technique for resection
Neoadjuvant therapy
Metastasis
Inflammatory bowel disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
63
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes. At the beginning of the randomization process, we randomly choose one of the following blocks by randomly throwing the dice and divide the rest of the samples into 2 groups according to the order of the samples. A: intervention and B: control B A B A 2) B B A A 1) B A A B 4) A B B A 3) A A B B 6) A B A B 5)
Blinding (investigator's opinion)
Double blinded
Blinding description
Based on the classification, people entered and will receive the planned treatment and intervention based on their specific group, and the results are recorded separately and based on coding. Patients, care providers and data analyzers are unaware and blinded to it, and only the surgical team is aware of the type of intervention. At the end of the study, the analyst uses the codes of the groups and the coding instructions to access the nature of the groups for analysis and conclusions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Khomeini Hospital ethics committe
Street address
Razi street, Sari,Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.2692
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of rectum
ICD-10 code
c20
ICD-10 code description
Malignant neoplasm of rectum
Primary outcomes
1
Description
Determining the average number of identified lymph nodes involved in the resected sample of rectal cancer by injecting methylene blue in the main artery of the sample
Timepoint
15 days
Method of measurement
pathology
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The inferior mesenteric arteries of 33 specimens were cannulated with a standard 17–20-G iv-catheter by the surgeon who is using this technique in order to check the integrity of the total mesorectal dissection. After that, the arteries were filled with 30 ml of methylene blue solution (15 mg diluted with 0.9% saline; ratio 1:1).and then specimen refer to pathology laboratory.
Category
Treatment - Surgery
2
Description
Control group: Total mesorectal dissection performed for control group with out any arterial injection
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Mina Alvandipour
Street address
Razi street, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
Minaalvh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahim Nejhad
Street address
Deputy of research and technology, Moalem sq. Sari, Mazandaran province
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3323 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mina Alvandipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Colorectal Surgery
Street address
Razi street, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
Minaalvh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Javad Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Razi Street, Sari, Mazandran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 911 223 5772
Email
mjnajafi@rocketmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Javad Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Razi street, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
mjnajafi@rocketmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data to complement research on the Methylene blue injection in artery of rectal specimen for lymph node identifying
From where data/document is obtainable
Contact the author of the article responsible for the research project data.
What processes are involved for a request to access data/document
Contact the author of the article responsible for the research project data.Specify the type of results requested.