The main objective of this investigation is to compare of complications and outcomes of three methods of appendectomy, consist of: 1-Laparoscopic 2-Single-incision 3-open appendectomy, in paediatric age group. Inclusion criteria: age between 8 to 14 years. Exclusion criteria: 1-patients with specific diseases (diabetes, congenital diseases and..) 2-use of Corticosteroid 3- presence of complicated appendicitis (generalized Peritonitis, abscess, phlegmon and gangrenous appendicitis). This study will be performed in 75 patients, which will randomly divided into three groups. The interventions consist of: group 1 undergoes open conventional appendectomy, group 2 will be treated by laparoscopic appendectomy and appendectomy in group 3 will be done using single incision appendectomy. Main outcome measures (variables) consist of: duration of surgery, wound infection, size of the scar and the time of hospital stay. This study will be carry-out in 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703088375N12
Registration date:2017-08-07, 1396/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
Seyed Amirkazem Vejdan
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
vejdan_sa@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of complications and outcomes of three methods of Laparoscopic appendectomy , Single-incision and open appendectomy in pediatric patients
Public title
Comparison of three methods of appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 8 to 14 years
Exclusion criteria: patients with specific disease such as diabetes; congenital diseases; immunosuppressive patients; consumption of Corticosteroid; patients with abdominal pain lasting more than 5 days; patients who have signs of generalized Peritonitis; the appendix complication such as perforation and Gangrenous appendicitis
Age
From 8 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
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
Birjand University of Medical Sciences
Street address
Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Postal code
Approval date
2017-03-01, 1395/12/11
Ethics committee reference number
ir.bums.REC.1395.250
Health conditions studied
1
Description of health condition studied
Acute appendicitis
ICD-10 code
K35.8
ICD-10 code description
Acute appendicitis without mention of localized or generalized peritonitis
Primary outcomes
1
Description
Duration of surgery
Timepoint
Starts from skin incision to wound clouser
Method of measurement
Minute
2
Description
Wound infection
Timepoint
The third day , The fifth day
Method of measurement
Number
3
Description
The size of the scar
Timepoint
14 days after surgery
Method of measurement
centimeter
4
Description
Hospital stay time
Timepoint
From admission to discharge
Method of measurement
Day
Secondary outcomes
empty
Intervention groups
1
Description
open appendectomy
Category
Treatment - Surgery
2
Description
Trans-umbilical single incision appendectomy
Category
Treatment - Surgery
3
Description
Laparoscopic appendectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Seyyed AmirKazem Vejdan
Street address
Taleghani street
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tuba Kazemy
Street address
Ghaffari Street , Birjand University of Medical Sciences
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Amir Kazem Vejdan
Position
Specialist in general surgery, Associate professor
Other areas of specialty/work
Street address
Imam Reza hospital
City
Birjand
Postal code
Phone
+98 915 161 3885
Fax
Email
vejdan_sa@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Amir Kazem Vejdan
Position
Specialist in general surgery, Associate professor
Other areas of specialty/work
Street address
Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 915 161 3885
Fax
Email
vejdan_sa@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Amir Kazem Vejdan
Position
specialis in general surgery / Associate professor
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Birjand
Postal code
Phone
+98 915 161 3885
Fax
Email
Vejdan,sa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)