Evaluation of the effect of peritoneal repair or non-repair on complications after open appendectomy
Design
Randomized specific study of intervention and control groups, blinded, parallel, supportive
Settings and conduct
candidates for surgery are randomly assigned to open appendectomy with two methods of repair and non-repair of peritoneum, followed by a telephone call and invitation to visit in person. Patients are visited at the specified time and are clinically examined for local postoperative complications, and the information about each of these complications is recorded and analyzed separately. If any of the complications that endanger the patient's condition are confirmed, the patient will be re-hospitalized
Participants/Inclusion and exclusion criteria
Patients with diagnosis of appendicitis and candidate for open appendectomy
Intervention groups
Perform open appendectomy with two methods of repair and non-repair of peritoneum
Main outcome variables
Severity of complications ,Incidence of complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200207046408N2
Registration date:2021-03-03, 1399/12/13
Registration timing:retrospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Reza Hosseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 1813
Email address
reza.hosseinpour@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2019-07-21, 1398/04/30
Trial completion date
2020-01-10, 1398/10/20
Scientific title
Evaluation of the effect of Peritoneal repair or non-repair on Complications after Open Appendectomy
Public title
Evaluation of the effect of Peritoneal repair or non-repair on Complications after Open Appendectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
En Patients Candidate for open Appendectomy
Exclusion criteria:
Patients with a diagnosis other than appendicitis
Patients with a diagnosis of appendicitis are candidates for medical treatment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Actual sample size reached:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual randomization, random number table randomization
Random number table is a set of numbers that are generated without a specific pattern or order and in a completely random manner and become a table. In order to use the table of random numbers, we first predetermined the table to read the numbers, then we considered the numbers for different groups, then we touched one of the numbers and moved in one of the predefined directions and recorded the numbers and We assigned to different groups.
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
کمیته اخلاق دانشگاه علوم پزشکی یاسوج
Street address
Shahid Beheshti Hospital, Montazeri St, Yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.YUMS.REC.1398.164
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35.80
ICD-10 code description
Unspecified acute appendicitis
Primary outcomes
1
Description
Relative frequency of hernia, relative frequency of operation site pain; Relative frequency of postoperative wound infection; Relative frequency of obstruction symptoms
Timepoint
One week, three months and six months after surgery
Method of measurement
Depending on the severity of the symptoms: asymptomatic, mild, moderate, severe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Peritoneal repair in 64 patients and postoperative visit three times
Category
Treatment - Surgery
2
Description
Control group: Non-peritoneal repair in 64 patients and postoperative visit three times
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj Shahid Beheshti Hospital
Full name of responsible person
Chamran Zakarya Nezhad Kasgary
Street address
Shahid Beheshti Hospital, Montazeri St, yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1814
Fax
Email
dr.mehdi.b.65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Yazdan Panah
Street address
Shahid Beheshti Hospital, Montazeri St, yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Email
dr.mehdi.b.65@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Chamran Zakarya Nezhad Kasgary
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Montazeri St, yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Email
dr.mehdi.b.65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Reza Hosseinpour
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Montazeri St, yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Fax
+98 74 3322 4722
Email
reza.hosseinpour@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Chamran Zakarya Nezhad Kasgary
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Montazeri St, yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Email
dr.mehdi.b.65@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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