Comparative study of surgical site infection incidence in patients with perforated peptic ulcer that undergo primary intention versus delayed primary(tertiary) intention
Incidence comparison of surgical site infection in each groups of study
Design
Randomised clinical trial with two different groups , parallel groups , single blinded , randomised and designed for 80 patients , randomisation with random number table
Settings and conduct
Patients with perforated peptic ulcer at imam reza hospital of kermanshah will divided into two groups and undergo different intentions and finally the outcome of each intention will compared. Patients and someone who divide them will not know which intention goes to whom
Participants/Inclusion and exclusion criteria
No entry if ; there is underlying disease , recent use of antibiotics , recent hospitalization , use of immunosuppressive drugs or corticosteroids
Intervention groups
The first group will undergo primary intention and the second group will undergo delayed primary intention
Main outcome variables
Incidence of surgical site infection in patients with primary intention ; Incidence of surgical site infection in patients with delayed primary intention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210508051227N1
Registration date:2022-03-11, 1400/12/20
Registration timing:registered_while_recruiting
Last update:2022-03-11, 1400/12/20
Update count:0
Registration date
2022-03-11, 1400/12/20
Registrant information
Name
arash koohihabibidehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6300
Email address
arash_koohi_ar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of surgical site infection incidence in patients with perforated peptic ulcer that undergo primary intention versus delayed primary(tertiary) intention
Public title
Comparative study of surgical site infection incidence in patients with perforated peptic ulcer that undergo primary intention versus delayed primary(tertiary) intention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with perforated peptic ulcer
Presence of peritonitis clinical sign that confirmed by surgeon
Presence of paraclinical findings that confirms peritonitis
Exclusion criteria:
Presence underlying disease like HIV , Diabetes , hepatitis , collagen vascular disease
Use antibiotics for one recent month
Hospitalization for 3 recent month
People with BMI more than 30
Using drugs like immunosuppressive or corticosteroid
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Numbers with random sequences are generated by PASS software and random number table and are encrypted into envelopes. The patient is then asked to choose one of the envelopes completely randomly (this part is done by one of the operating room staff or a doctor who does not know the details of the plan) and based on the number in the envelopes, the surgical method is selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
Primary intention method is considered as the basic method and delayed primary intention method is considered as the intervention method. Due to the assignment of encrypted envelopes containing numbers determining the type of surgery to each patient, as a result, patients are unaware of the type of intention method assigned to them.(Before presenting the envelopes to the patients, both types of surgical procedures and their complications will be explained to the patients and the consent of both surgeries will be taken from them). Considering that the intervention is a type of surgical procedure that the difference between them is in the kind of surgical incision and unlike the medical interventions, the patient will notice the surgical method after regaining consciousness according to the explanations given to him before the surgery in relation to the two existing types of surgery. As a result, blinding is performed only until surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kermanshah University of Medical Sciences
Acute peptic ulcer, site unspecified, with perforation
Primary outcomes
1
Description
incidence of surgical site infection
Timepoint
14 days
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
In this group, delayed primary intention is performed. In this way, after the perforation is repaired, all the layers of the abdominal wall are closed after surgery, and only the skin of the abdominal wall remains open for 5 days, and then it is sutured.
Category
Treatment - Surgery
2
Description
In this group, the primary intention method is performed. In this way, after perforation repair, all layers of the abdominal wall, including the skin, are sutured in the operating room immediately after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imamreza hospital
Full name of responsible person
Ali Toolabi
Street address
next to the medical school, Parastar blvd
City
krmanshah
Province
Kermanshah
Postal code
75333 - 67427
Phone
+98 83 3427 6300
Email
irhk @kums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sasan Jamshidi
Street address
Shahidbehshti Blvd , Kermanshah University of Medical Sience
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3835 0097
Email
Mcollege@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Toolabi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 20 , 11metri dovvom , mousa kalantari ave
City
Kermanshah
Province
Kermanshah
Postal code
6715746687
Phone
+98 921 337 8018
Email
ali.toolabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Toolabi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 20 , 11 Metri Dovvom , Mousa Kalantari Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715746687
Phone
+98 921 337 8018
Email
ali.toolabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Toolabi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 20 , 11 metri dovvom , mousa kalantari ave
City
Kermanshah
Province
Kermanshah
Postal code
6715746687
Phone
+98 921 337 8018
Email
ali.toolabi@yahoo.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