Protocol summary

Study aim
Comparison of single-incision laparoscopic appendectomy with conventional laparoscopic appendectomy in terms of short-term outcomes.
Design
Clinical trial with a control group, parallel groups, one blinded, randomized, on 28 patients. Used G*Power software for randomization
Settings and conduct
Clinical trial study will be used in this research. The study will be conducted in Imam Ali Hospital of Alborz province and Karaj city To 3 weeks after the operation, information will be collected through a questionnaire and questions from the patient In this single-blind study, the patients will be unconscious during the surgery and will not be informed about which method the surgery will be performed. The research team (interviewers) will know which surgery was performed on which person.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: Consent to participate in the research, age below 20 years, Stable patient Exclusion criteria from the research: Age over 20 years, abdominal infection, emergency case, pregnancy, perforated appendicitis
Intervention groups
The main intervention is single-incision laparoscopic appendectomy, which is performed randomly for a number of patients under 20 years of age. Also, a number of patients under 20 years of age undergoing routine laparoscopic appendectomy surgery are considered as a control group and for the purpose of comparison with the previous group, and the research will carry out in Imam Ali educational and therapeutic center located in Alborz province, Karaj city in 1401- 1402
Main outcome variables
Short-term consequences include beauty of the operation site; postoperative pain; operation complications (operation site infections, fever, redness and swelling of the abdomen, damage to adjacent organs and bleeding); operation duration; hospitalization time (IV anti biotic therapy time) and the duration of leukocytosis drop

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220530055027N1
Registration date: 2022-10-15, 1401/07/23
Registration timing: prospective

Last update: 2022-10-15, 1401/07/23
Update count: 0
Registration date
2022-10-15, 1401/07/23
Registrant information
Name
Narges Khaleghi rostamkolaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4410 8369
Email address
atousakhaleghi71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-23, 1401/10/02
Expected recruitment end date
2023-04-22, 1402/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of short time outcomes between single incision laparoscopic appendectomy and conventional laparoscopic appendectomy surgery
Public title
The comparison of single incision laparoscopic appendectomy and conventional laparoscopic appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the research Age under 20 years Stable patient
Exclusion criteria:
Over 20 years old Abdominal infection Emergency Case Pregnancy Perforated appendicitis
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: 28
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed written consent from the individual and his legal guardian, the allocation of people to treatment groups will be done based on the sequence obtained from the 4 blocks obtained from the address below. https://www.sealedenvelope.com/simple-randomiser/v1/lists Also, the list of random allocation in 7 blocks of 4, which makes 28 people in each group, is as follows: • 1, 4, 1, Group B • 1, 4, 2, Group B • 1, 4, 3, Group A • 1, 4, 4, Group A • 2, 4, 1, Group B • 2, 4, 2, Group A • 2, 4, 3, Group A • 2, 4, 4, Group B • 3, 4, 1, Group B • 3, 4, 2, Group A • 3, 4, 3, Group B • 3, 4, 4, Group A • 4, 4, 1, Group A • 4, 4, 2, Group B • 4, 4, 3, Group A • 4, 4, 4, Group B • 5, 4, 1, Group A • 5, 4, 2, Group B • 5, 4, 3, Group A • 5, 4, 4, Group B • 6, 4, 1, Group B • 6, 4, 2, Group A • 6, 4, 3, Group A • 6, 4, 4, Group B • 7, 4, 1, Group A • 7, 4, 2, Group A • 7, 4, 3, Group B • 7, 4, 4, Group B
Blinding (investigator's opinion)
Single blinded
Blinding description
In this one-sided blind study, the patients will be unconscious during the surgery and will not be informed about which method the surgery will be performed. The research team (interviewers) will know which surgery was performed on which person.
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 merti Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2022-09-24, 1401/07/02
Ethics committee reference number
IR.ABZUMS.REC.1401.175

Health conditions studied

1

Description of health condition studied
Single incision laparoscopic appendectomy (SILA)
ICD-10 code
K35
ICD-10 code description
Acute appendicitis

2

Description of health condition studied
Conventional laparoscopic appendectomy
ICD-10 code
K35
ICD-10 code description
Acute appendicitis

Primary outcomes

1

Description
The degree of beauty of the operation site
Timepoint
Up to 3 weeks after surgery
Method of measurement
Based on the PSQ questionnaire

2

Description
The amount of pain after the operation
Timepoint
Up to 3 weeks after surgery
Method of measurement
Based on the VAS questionnaire

3

Description
Types of complications after surgery
Timepoint
Up to 3 weeks after surgery
Method of measurement
Self-Report

4

Description
Duration of operation
Timepoint
During surgery
Method of measurement
Based on the duration of surgery

5

Description
Duration of hospitalization
Timepoint
From after surgery to discharge
Method of measurement
Record the number of days of hospitalization

6

Description
Duration of leukocytosis drop
Timepoint
It is measured once before the operation and once or twice after the operation
Method of measurement
Record the duration of leukocytosis drop

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Single-incision laparoscopic appendectomy
Category
Treatment - Surgery

2

Description
Control group: Conventional laparoscopic appendectomy
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Narges Khaleghi Rostamkolaie
Street address
Vali Asr Boulevard, Shura Boulevard, Islamabad, Imam Ali Hospital
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 21 4410 8369
Email
atousakhaleghi71@gmail.com

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?
Yes
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
Narges Khaleghi Rostamkolaie
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 2, 1st sarv, sarv st, east farsad Blv, Taavon Blv. Shahre Ziba
City
tehran
Province
Tehran
Postal code
1487765415
Phone
+98 21 4410 8369
Email
atousakhaleghi71@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Narges Khaleghi rostamkolaie
Position
Intern
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No 2, 1st sarv, sarv st, east farsad Blv, Taavon Blv. Shahre Ziba
City
Tehran
Province
Tehran
Postal code
1487765415
Phone
+98 21 4410 8369
Fax
Email
atousakhaleghi71@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Narges Khaleghi rostamkolaie
Position
Intern
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
No 2, 1st sarv, sarv st, east farsad Blv, Taavon Blv. Shahre Ziba
City
Tehran
Province
Tehran
Postal code
1487765415
Phone
+98 21 4410 8369
Fax
Email
atousakhaleghi71@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
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