Comparison of modified subcutaneous running suture versus vertical mattress sutures on cosmetic and
post operative outcomes in appendectomy surgery
Design
The clinical trial has a control group with parallel groups, one-sided blind, randomized with two groups consisting of 90 patients who were randomized using the website www.sealedenvelope.com and 60 patients were included in the control group and 30 patients in the trial group.
Settings and conduct
Appendectomy surgery is performed with the two types of sutures described above in Imam Ali Karaj Hospital
Participants/Inclusion and exclusion criteria
Entry requirements :
Consent to participate in research/age below 20 years/stable patient
Non-entry conditions:
Age over 20 years/abdominal infection/emergency case/pregnancy/perforated appendicitis
Intervention groups
The intervention is a type of suture
trial group: modified subcutaneous suture
control group: vertical mattress suture
Main outcome variables
Suture type/Scar evaluation from the point of view of aesthetics/Post-operative pain level/Duration of suture/Symptoms due to infection/Duration of hospitalization/Age/Gender/Weight/Height
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221210056767N1
Registration date:2022-12-17, 1401/09/26
Registration timing:prospective
Last update:2022-12-17, 1401/09/26
Update count:0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Saba Ghaemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3420 6031
Email address
s.ghaemi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of modified subcutaneous running suture versus vertical mattress sutures on cosmetic and post operative outcomes in appendectomy surgery
Public title
Comparison of modified subcutaneous running suture versus vertical mattress sutures on cosmetic and post operative outcomes in appendectomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the research
Age under 20 years old
Stable patient
Exclusion criteria:
Age more than 20 years old
Abdominal infection
Perforated Appendicitis
Pregnancy
Age
From 1 year old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
We make an envelope for each patient, and in each envelope we put twice the chance of the control and one time the chance of the trial, that is, two green cards (control group) and one red card (trial group) in each envelope.
we put . Then we randomly remove a card from the envelope, if the card is green, the patient is In the control category, if the card is red, the patient is included in the trial group.
Regarding randomization, 6 random blocks were generated with the help of www.sealedenvelope.com , where the number of group a is twice the number of group b.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is not aware of the type of suture used in the surgery
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
Ethics committee office, 2nd floor, Research and Technology Vice-Chancellor, Safarian Alley, 45 metri Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.ABZUMS.REC.1401.248
Health conditions studied
1
Description of health condition studied
modified subcutaneous running suture
ICD-10 code
ICD-10 code description
2
Description of health condition studied
cosmetic result of scar
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Appendectomy surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Scar review in terms of beauty
Timepoint
6 weeks after surgery
Method of measurement
Based on the PSQ questionnaire
2
Description
The amount of pain after the operation
Timepoint
6 weeks after surgery
Method of measurement
Based on the VAS questionnaire
3
Description
Symptoms caused by infection
Timepoint
6 weeks after surgery
Method of measurement
Based on the form in which the symptoms are explained to the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the use of continuous subcutaneous sutures in appendectomy surgery, where the major part of the wound is sutured subcutaneously and continuously, and finally a simple suture is applied.
Category
Treatment - Surgery
2
Description
Control group: Using a vertical mattress suture method that is commonly used in appendectomy surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Saba Ghaemi
Street address
Imam Ali Hospital, Vali Asr Boulevard, Shora Boulevard, Islam Abad
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3252 7576
Email
emamali@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Research and Technology Vice-Chancellor, Safarian alley, Golshahr 45 metri
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3922
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Saba Ghaemi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 47, Marjan alley, South Kasra Street, Jahanshahr
City
Karaj
Province
Alborz
Postal code
3144859453
Phone
+98 26 3420 6031
Email
saba.ghaemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Saba Ghaemi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 47, Marjan alley, South Kasra Street, Jahanshahr
City
Karaj
Province
Alborz
Postal code
3144859453
Phone
+98 26 3420 6031
Email
saba.ghaemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Saba Ghaemi
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 47, Marjan Alley, South Kasra Street, Jahanshahr
City
Karaj
Province
Alborz
Postal code
3144859453
Phone
+98 26 3420 6031
Email
saba.ghaemi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no further information
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