The aim is Comparison abdominal washing in patients with acute peritonitis using “normal saline solution with trolls” compared with “normal saline solution”.
Design
This assessment is a clinical trial in phase 3; neonates who are diagnosed with peritonitis are considered as study group. In this study, 20 patients with inclusion criteria are selected. Patients are randomly assigned to the blockade method, 10 patients in normal lavage with normal saline and 10 patients in normal lavage with normal saline and trolls group. Accordingly, after surgery, the signs and symptoms associated with peritonitis are evaluated.
Settings and conduct
This study was carried out as a clinical trial at the Shohaday Khalije Fars Hospital in Bushehr, Also the study will be single blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Patients with peritonitis aged 15 to 65 years are included in the study as well as patients with evidence of intestinal encephalopathy, liver and kidney disease, history of steroid use, history of hypersensitivity and allergy to substances containing citrate, multiple trauma and organ damage in the event of vascular rupture and pregnancy are excluded from the study.
Intervention groups
In the intervention group, abdominal lavage was performed using normal saline and trolls and in the control group, abdominal lavage was done by normal saline.
Main outcome variables
Signs and Symptoms of Peritonitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190304042923N1
Registration date:2019-03-15, 1397/12/24
Registration timing:retrospective
Last update:2019-03-15, 1397/12/24
Update count:0
Registration date
2019-03-15, 1397/12/24
Registrant information
Name
mohammad amin rezari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5364 2934
Email address
rezaei@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-05, 1397/01/16
Expected recruitment end date
2018-10-08, 1397/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison abdominal washing in patients with acute peritonitis using “normal saline solution with trolls” compared with “normal saline solution”
Public title
Evaluation effect of abdominal washing in patients with acute peritonitis using normal saline solution with trolls
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute Peritonitis
Age more than 15 years and under 65 years
Exclusion criteria:
enteric encephalopathy
Liver disease
kidney Diseases
History of steroid use
History of allergy and allergic to citrate-containing substances
Multiple trauma and organ damage in case of vascular rupture
Pregnancy
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization we will use the block method, Accordingly, the patients under study are divided into two groups.
The allocation of patients in two groups was based on demographic characteristics and their matching.
Based on this, after considering the patients' demographic data, patients were divided into two equal groups of patients, they enrolled in the study and performed desired intervention on them.
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs, and drugs has similar packaging.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Bushehr Province, Bandar Bushehr, Kuy-e-Bandar, Moallem St، Iran
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2019-03-01, 1397/12/10
Ethics committee reference number
IR.BPUMS.REC.1397.123
Health conditions studied
1
Description of health condition studied
Peritonitis
ICD-10 code
K65
ICD-10 code description
Peritonitis
Primary outcomes
1
Description
Peritonitis
Timepoint
After the surgery
Method of measurement
According to the general state, the respiratory state, the symptoms of local infection, symptoms of systemic infection, heart rate, respiratory rate, blood loss, body temperature, wound healing, suture location, infection, abdominal sign and symptom, as well as abdominal abscesses is examined by ultrasound or CT scan if necessary.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, abdominal lavage is used by normal saline and trolls.
Category
Treatment - Surgery
2
Description
Control group: In this group, abdominal lavage is used by normal saline.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohaday Khalije Fars Hospital
Full name of responsible person
Mohammad Amin Rezaei
Street address
Pardis Blvd, University Blvd.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 76 3367 0280
Email
rezaei@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Bushehr University Of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 1455 2247
Email
Ghr.Khamisi@Gmail.Com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Mohammad Amin Rezaei
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pardis Blvd, University Blvd, Bushehr University Of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 76 3367 0280
Email
rezaei@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mohammad Amin Rezaei
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pardis Blvd, University Blvd, Bushehr University Of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 76 3367 0280
Email
rezaei@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mohammad Amin Rezaei
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pardis Blvd, University Blvd, Bushehr University Of Medical Sciences
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 76 3367 0280
Email
rezaei@bpums.ac.ir
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