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IRCT20230809059096N2 IRCT 2024-02-17 Mazandaran University of Medical Sciences Enhancing lymph node detection in rectal specimens: The role of Methylene Blue arterial injection 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 2018-12-22 anticipated 60 Complete https://irct.ir/trial/74708 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Malignant neoplasm of rectum. Intervention 1: 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. Intervention 2: Control group: Total mesorectal dissection performed for control group with out any arterial injection. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome or the like, can be shared. When: Start of access period 6 months after printing results To whom: It will be available to researchers working in academic and scientific institutions. Conditions: Use of data to complement research on the Methylene blue injection in artery of rectal specimen for lymph node identifying Where to obtain: Contact the author of the article responsible for the research project data. How to obtain: Contact the author of the article responsible for the research project data.Specify the type of results requested. Comments:
public Mina Alvandipour
Razi street, Sari, Mazandaran
Sari Iran (Islamic Republic of) 4816633131 +98 11 3336 1700 Minaalvh@yahoo.com Mazandaran University of Medical Sciences scientific Mohammad Javad Najafi
Razi Street, Sari, Mazandran
Sari Iran (Islamic Republic of) 4816633131 +98 911 223 5772 mjnajafi@rocketmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 80 Rectum cancer 18 years 80 years Both Massive and invasive tumors that require a special technique for resection Neoadjuvant therapy Metastasis Inflammatory bowel disease c20 Malignant neoplasm of rectum Treatment - Surgery Other 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. Control group: Total mesorectal dissection performed for control group with out any arterial injection 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. Mazandaran University of Medical Sciences Approved 2018-06-30 Imam Khomeini Hospital ethics committe Razi street, Sari,Mazandaran Sari Mazandaran Iran (Islamic Republic of)