Comparison of appendectomy through right abdominal crural crease approach versus standard method in patients with acute appendicitis without complication: a randomized clinical trial
Objectives: Comparison of appendectomy through right abdominal crural crease approach versus standard method.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with acute appendicitis without complication who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Acute appendicitis without complication
Exclusion criteria: (a) Disseminated peritonitis; (b) appendix variation toward sub hepatic area; (c) indication of laparotomy.
Intervention group: Appendectomy through right abdominal crural crease approach.
Control group: Appendectomy through standard method.
Primary outcome: Measuring surgical scar 10 days after surgery using a ruler.
Secondary outcome: assessing infection at the surgical location 10 days after surgery through physical examination.
Randomization: The patients will be randomly assigned to intervention and control groups using drawing a lot.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606209014N102
Registration date:2016-06-23, 1395/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-23, 1395/04/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-04-10, 1392/01/21
Expected recruitment end date
2014-04-10, 1393/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of appendectomy through right abdominal crural crease approach versus standard method in patients with acute appendicitis without complication: a randomized clinical trial
Public title
Comparison of appendectomy through right abdominal crural crease approach versus standard method in patients with acute appendicitis without complication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Acute appendicitis without complication
Exclusion criteria: (a) Disseminated peritonitis; (b) appendix variation toward sub hepatic area; (c) indication of laparotomy.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using drawing a lot.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-01-13, 1392/10/23
Ethics committee reference number
D/P/16/35/9/3570
Health conditions studied
1
Description of health condition studied
Acute appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Measuring surgical scar
Timepoint
10 days after surgery
Method of measurement
using a ruler
Secondary outcomes
1
Description
Assessing infection at the surgical location
Timepoint
10 days after surgery
Method of measurement
through physical examination
Intervention groups
1
Description
Appendectomy through right abdominal crural crease approach
Category
Treatment - Surgery
2
Description
Appendectomy through standard method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Alireza Nemati Motehaver
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Alireza Nemati Motehaver
Position
Resident of sugery
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
rezanematimotehaver@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Mahdi Eskandarlou
Position
Surgeon
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
eskandarlou.m@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)