- Comparison of quality of life in patients undergoing appendectomy by laparotomy and laparoscopy
Design
Randomised, not blinded, two arm parallel group
Settings and conduct
In this clinical trial at Allameh Bohlol Hospital, patients undergoing laparoscopic and laparotomy are randomly selected and their quality of life is compared with SF-36 questionnaire. The quality of life of participants before and one month after surgery will be re-evaluated with the same instrument.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent to participate in the study
- Literacy for reading and writing
- Being alert
Lack of perforation of appendicitis and peritonitis and other open or laparoscopic surgical contraindications
- Over 18 years old
- No chronic disease
- Lack of mental retardation
- No history of mental illness, sedation and anxiolytics
- Lack of experience of a stressful accident in the last 6 months
- No drug use
Exclusion criteria:
- Patient failure to participate in the research process
- Occurrence of physical, psychological and social problems for any reason
Intervention groups
A group undergoing laparoscopic appendectomy
A group undergoing laparotomy appendectomy
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190606043825N1
Registration date:2020-01-30, 1398/11/10
Registration timing:registered_while_recruiting
Last update:2020-01-30, 1398/11/10
Update count:0
Registration date
2020-01-30, 1398/11/10
Registrant information
Name
Hamid Reza Niazkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3830 5189
Email address
niazkar@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Two Methods of Laparotomy and Laparoscopic Appendectomy on Quality of Life
Public title
Comparison the Effect of Two Methods of Laparotomy and Laparoscopic Appendectomy on Quality of Life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent to participate in the study
Literacy for reading and writing
Being vigilant
Lack of perforation of appendicitis and peritonitis and other open or laparoscopic surgical contraindications
Not having chronic disease
Not having mental retardation
No history of mental illness, sedatives and anti-anxiety drugs
No history of a stressful accident in the last 6 months
Not using drugs
Exclusion criteria:
Not being cooperate in the research process
Occurrence of physical, psychological and social problems for any reason
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
A two-group web randomization (www.graphpad.com) is used to create simple random sequences. Random assignment was performed using sequence envelope method (SNOSE). The random assignment process will be performed by a person other than the research team.
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
Ethics committee of Gonabad University of Medical Sciences
Street address
Sento Blv. Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-08-07, 1398/05/16
Ethics committee reference number
IR.GMU.REC.1398.092
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Quality of life
Timepoint
Before surgery and one month after surgery
Method of measurement
SF-36 Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Laparoscopy appendectomy
Category
Treatment - Surgery
2
Description
Intervention group: Laparotomy appendectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlol Hospital, Gonabad, Iran
Full name of responsible person
Dr Mohammad Sadegh Ramezani
Street address
Nurse Blv,Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3514
Email
ms.ramezani@outlook.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Abdoljavad Khajavi
Street address
Seno Blv, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3514
Email
ms.ramezani@outlook.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mohammad Sadegh Ramezani
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sento Blv, Gonabad, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
ms.ramezani@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mohammad Sadegh Ramezani
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sento Blv. Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
ms.ramezani@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Hamid Reza Niazkar
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sento Blv. Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5723 6833
Email
hrn185@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potentially unidentified individuals data will be made available after the publication
When the data will become available and for how long
When the research is published online
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Email ms.ramezani@outlook.com
What processes are involved for a request to access data/document
Email to ms.ramezani@outlook.com
Will be sent in a week.