This study is a clinical trial without blinding and will be conducted in parallel and by comparing two types of surgery on 240 patients with colon cancer in Al-Zahra Medical Center.Patients were randomly divided into two groups using Excel software.
Settings and conduct
This study is a clinical trial without blinding and will be conducted in parallel and by comparing two types of surgery on 240 patients with colon cancer in Al-Zahra Medical Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Colon cancer diagnosis confirmation based on pathology report Patients who undergo curative surgery.
Inclusion criteria:History of cancer surgery in another part of the body, Chemotherapy or radiotherapy before surgery, Presence of simultaneous tumor in the rectum and colon, Presence of simultaneous tumor in two segments of the colon
Intervention groups
Group (A) For this group, surgery is performed using D2 method. For group (b), surgery is performed by the method of complete removal of the mesocolon.
Main outcome variables
Preventing possible complications from surgery and reducing mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N7
Registration date:2024-03-17, 1402/12/27
Registration timing:prospective
Last update:2024-03-17, 1402/12/27
Update count:0
Registration date
2024-03-17, 1402/12/27
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-13, 1403/01/25
Expected recruitment end date
2024-07-15, 1403/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcome and side effects of colectomy by D2 method with complete removal of mesocolon in patients with colon cancer
Public title
Comparison of D2 colectomy with complete mesocolon resection in patients with colon cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Colon cancer diagnosis confirmation based on pathology report
Patients who undergo curative surgery
Exclusion criteria:
History of cancer surgery in another part of the body
Chemotherapy or radiotherapy before surgery
Presence of simultaneous tumor in the rectum and colon
Presence of simultaneous tumor in two segments of the colon
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
People are placed in 2 groups by random block method.
With the easy sampling method, the referring people who are eligible to enter the study are randomly divided into two groups. In this study, the classification of people is done by the four permutation block method. In this method, A represents a person who undergoes surgery with a routine method, and B represents a person who undergoes surgery with a new method. Considering the quadruple block, we give AABB code 0, ABAB code 1, ABBA code 2, BAAB code 3, BBAA code 4, and BABA code 5 to 9. Then, using the table of random numbers, we randomly select a starting point and then consider the numbers in rows or columns. Considering the order of the numbers in the table, we place the corresponding permutation on each number we come across. Finally, 120 people will be divided into two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-08-11, 1401/05/20
Ethics committee reference number
IR.MUI.MED.REC.1401.192
Health conditions studied
1
Description of health condition studied
Colon cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
Preventing anastomotic leakage
Timepoint
Seven days after surgery
Method of measurement
Clinical examination, patient's condition and discharge from Medline
2
Description
Recurrence of the disease
Timepoint
routinely
Method of measurement
CT scan and Carcinoembryonic Antigen (CEA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Complete removal of the mesocolon
Category
Treatment - Surgery
2
Description
Control group: D2 methods
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Behnam Sanei
Street address
Al-zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 115 2604
Email
b_sanei@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hazar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
Behnam Sanei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Al-zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 115 2604
Email
b_sanei@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behnam Sanei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Al-zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 115 2604
Email
b_sanei@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Pooriya Fatehi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 114 4399
Email
pooriyafatehi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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