The aim of this study was to evaluate the incidence of right inguinal hernia in laparoscopic appendectomy.
Design
Patients are randomly will divide into two groups under treatment with open appendectomy and laparoscopic appendectomy
Settings and conduct
Patients with acute appendicitis referred to Modarres Hospital are divided into two groups, treated by open appendectomy and laparoscopic appendectomy, by matching between age and sex variables. One year after surgery, they undergo inguinal ultrasougraphy
Participants/Inclusion and exclusion criteria
This prospective study is performed in Modarres Hospital,Tehran, between2018-2020 Patients with a clinical diagnosis of acute appendicitis who candidate for appendectomy on the basis of the Alvarado are enrolled . Patients who could not under gone laparoscopic surgery willexcluded.
Intervention groups
groups under treatment with open appendectomy and group laparoscopic appendectomy
Main outcome variables
Incidence of inguinal hernias
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160803029181N7
Registration date:2019-11-11, 1398/08/20
Registration timing:registered_while_recruiting
Last update:2019-11-11, 1398/08/20
Update count:0
Registration date
2019-11-11, 1398/08/20
Registrant information
Name
Nasser Malekpour Alamdari
Name of organization / entity
Shaid Behesht University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4089
Email address
nassermalekpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of laparoscopic appendectomy and open appendectomy for Incidence of inguinal hernia
Public title
Laparoscopic appendectomy versus open appendectomy for inguinal hernia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Clinical Diagnosis of Acute Appendicitis who Candidate for Appendectomy based on the Alvarado
Exclusion criteria:
Patients who could not undergone laparoscopic surgery will excluded.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly will divide into two groups under treatment with open appendectomy and laparoscopic appendectomy.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer does not know the intervention type
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
International Affairs Department
Street address
13th Floor,Block A,the Ministry of Health and Medical Education,between South Flamak and Zarafshan, Iran Sima AveQods Town (West),,
City
tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2019-10-12, 1398/07/20
Ethics committee reference number
IR.SBMU.MSP.REC.1398.740
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
inguinal hernia
Timepoint
after 1 year
Method of measurement
sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Group will treat with laparoscopic appendectomy after confirm diagnosis with three ports method( Olympus Keymed, UK)
Category
Treatment - Surgery
2
Description
Intervention group 2: Group will treated with open appendectomy with McBurney's incision after confirm
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Nasser Malekpour
Street address
Modarres Hospital;Kaj Sq;Saadat Abad;
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Fax
+98 21 2206 9355
Email
nassermalekpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyyed Ali Ziai
Street address
Danshju Ave Velenjak
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4087
Email
aliziai@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
ShahidBeheshti University Of Medical Sciences,Arabi street,Velenjak.
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2207 4088
Fax
+98 21 2207 4088
Email
nassermalekpour@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasser Malekpour Alamdari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shaid Behesht University of Medical Sciences, Arabi street, Velenjak.
City
tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4089
Fax
+98 21 2207 4101
Email
nassermalekpour@sbmu.ac.ir
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