Surgical outcome of scalpel verus Diathermy skin lesion in uncomplicated appendectomy
Design
The study will be double blind and clinical trial.72 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients candidate for uncomplicated appendectomy surgery in valiasr Hospital in Arak are divided into 2 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:20 to 50 years, lack of underlying diseases, patients in need of appendicitis surgery, absence of previous abdominal surgery, do not use corticosteroids and immunosuppressive drugs
Exclusion criteria: Gangrenous appendicitis , abscess appendicitis, cardiac-respiratory arrest during surgery, wound infection during surgery
Intervention groups
In the first group, the skin is cut from the skin to the fascia with a cutter with a cutting mode, and in the second group, the skin is cut from the skin to the fascia using a scalpel.
Main outcome variables
Infection, hematoma, pain, scar scar examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N175
Registration date:2022-05-09, 1401/02/19
Registration timing:prospective
Last update:2022-05-09, 1401/02/19
Update count:0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2023-05-05, 1402/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surgical outcome of scalpel verus Diathermy skin lesion in uncomplicated appendectomy
Public title
Surgical outcome of scalpel verus Diathermy skin lesion in uncomplicated appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20 to 50 years
Lack of underlying diseases
Patients in need of appendicitis surgery
Absence of previous abdominal surgery
Do not use corticosteroids and immunosuppressive drugs
Exclusion criteria:
Gangrenous appendicitis
Abscess appendicitis
Cardiac-respiratory arrest during surgery
Wound infection during surgery
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 2 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The analysis is done by the analyst and outcome evaluator (two-blind) and the participant. Analysts, evaluators and participants are not aware of the consequences of grouping. The specialist assistant is unaware of the type of operation in each group and the surgeon is aware of the type of operation and patients are not aware of their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.ARAKMU.REC.1400.360
Health conditions studied
1
Description of health condition studied
uncomplicated appendectomy
ICD-10 code
K35.8
ICD-10 code description
Other and unspecified acute appendicitis
Primary outcomes
1
Description
Infection
Timepoint
After surgery
Method of measurement
Physical examination
2
Description
Hematoma
Timepoint
After surgery
Method of measurement
Physical examination
3
Description
Pain
Timepoint
After surgery
Method of measurement
Physical examination
4
Description
Examination of wound scars
Timepoint
After surgery
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: the skin is cut from the skin to the fascia with a cutter with a cutting mode
Category
Treatment - Surgery
2
Description
Intervention group2: the skin is cut from the skin to the fascia using a scalpel.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Siamak Rakei
Street address
Valiasr squre, Valiasr hospital
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
s.rakei@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Siamak Rakei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street