Comparison of wound complication in anal area between two methods of primary repair and Limburg flap repair in abdominoperineal resection in rectal cancer
Comparison of wound complication in anal area between two methods of primary repair and Limburg flap repair in abdominoperineal resection in rectal cancer
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 50 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.
Patients were randomly divided into two groups. All patients underwent Abdominoperineal Resection. The type of anal skin repair method was different in two groups.
Primary group or initial repair of anal wound = in this method, the anal area was performed as a primary repair and in the middle line.
Limberg flap group = repair by flap method In this method, the anal area was repaired by Limberg flap method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20 t0 90 years old with rectal cancer that underwent abdominoperineal resection.
Exclusion criteria: no fallow up
Intervention groups
Patients were randomly divided into two groups. All patients underwent Abdominoperineal Resection. The type of anal skin repair method was different in two groups.
control group or initial repair of anal wound = in this method, the anal area was performed as a primary repair and in the middle line.
Limberg flap group = repair by flap method In this method, the anal area was repaired by Limberg flap method.
Main outcome variables
Occurrence of infection, discharge, bleeding from the anal wound site, anal wound healing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059096N1
Registration date:2024-01-30, 1402/11/10
Registration timing:retrospective
Last update:2024-01-30, 1402/11/10
Update count:0
Registration date
2024-01-30, 1402/11/10
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
2019-07-23, 1398/05/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2020-02-01, 1398/11/12
Actual recruitment end date
2021-05-01, 1400/02/11
Trial completion date
2021-05-01, 1400/02/11
Scientific title
Comparison of wound complication in anal area between two methods of primary repair and Limburg flap repair in abdominoperineal resection in rectal cancer
Public title
Limberg flap repair in wound healing of anal surgery site in Abdominoperineal Resection surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 t0 90
Rectum cancer
Abdominoperineal resection
Exclusion criteria:
No follow up
Age
From 20 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
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 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
2019-07-16, 1398/04/25
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.084
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
Incidence of infection
Timepoint
One day, 7 days, 14 days, one month after the operation
Method of measurement
Lab data and physical exam
2
Description
Bleeding
Timepoint
One day, 7 days after the operation
Method of measurement
Lab data and physical exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Flap repair in the anal area using the Limberg flap method
Category
Treatment - Surgery
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
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 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
Amir-e-Mazandarani Street, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 911 223 5772
Fax
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
Amir-e-Mazandarani Street, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 911 223 5772
Fax
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 supplement research on anal wound repair using the Limburg flap method
From where data/document is obtainable
Contact the author of the article responsible for the research project data.
Dr mohammad Javad Najafi
E-mail: mjnajafi@rocketmail.com
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.