The purpose of this study is to determine the therapeutic role of oral Gastrografin in cases of small bowel obstruction who did not response to conservative treatments.this is a single arm stydy, not blinded,without using any placebo,single assignment and interventional.Inclusion criteria: patients older than 16 years hospitalized as adhesive small bowel obstruction.Exclusion criteria: 1) strangulation signs and symptoms.2) patients younger than 16 years old.3) patients with documented intra abdominal malignancy ,IBD or history of abdominal irradiation.sample size at least 30 patients.all the patients admitted to Qazvin Velayat hospital in 4 month with adhesive partial small bowel obstruction without any signs and symptoms of strungulation can participate in our study after they sign the permission paper.these patients receive oral gastrografin and evalute in 48 hours to determine if their signs reduce or improve.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082829567N1
Registration date:2016-09-25, 1395/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-25, 1395/07/04
Registrant information
Name
Rezvan Barkhordari
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 283336001
Email address
r.barkhordari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
nothing
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of oral Gastrografin in the management of postoperative adhesive, partial small-bowel obstruction
Public title
Therapeutic effect of oral Gastrografin in the management of partial small-bowel obstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 16 years hospitalized as adhesive small bowel obstruction with no signs or symptoms of strungulation
Exclusion criteria: 1) strangulation signs and symptoms
2) patients younger than 16 years old
3) patients with documented intra abdominal malignancy ,IBD or history of abdominal irradiation.
Age
From 16 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Science
Street address
Qazvin University of Medical Science, Bahonar blvd, Qazvin
City
Qazvin
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.QUMS.REC.1395.95
Health conditions studied
1
Description of health condition studied
Adhesive Small Bowel Obstruction
ICD-10 code
K56.5
ICD-10 code description
Intestinal adhesions [bands] with obstruction
Primary outcomes
1
Description
Nausea
Timepoint
Befor and after gastrografin
Method of measurement
Questionair
2
Description
Vomitting
Timepoint
Befor and after gastrografin
Method of measurement
Questionair
3
Description
Colicy abdominal pain
Timepoint
Befor and after gastrografin
Method of measurement
Questionair
4
Description
Abdominal distention
Timepoint
Befor and after gastrografin
Method of measurement
Questionair
5
Description
Fever
Timepoint
Befor and after gastrografin
Method of measurement
Questionair
6
Description
Constipation
Timepoint
Befor and after gastrografin
Method of measurement
Questionair
Secondary outcomes
empty
Intervention groups
1
Description
Gastrografin meal(2 ampule+100cc water) in 24 hours after admission in hospital ( 1 or 2 meal) and evaluation within 48 hours after that.if there is any signs or symptoms of strungulation surgery will performed as soon as possible
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Rezvan Barkhordari
Street address
Velayat Hospital, Minoodar square, Qazvin City
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Dr.Farzam
Street address
Qazvin University of Medical Science, Bahonar blvd, Qazvin City
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Dr Hossein Parsa
Position
Professor of Vascular Surgery
Other areas of specialty/work
Street address
Qazvin University of Medical Science
City
Qazvin
Postal code
Phone
+98 283336003
Fax
Email
r.barkhordari@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Rezvan Barkhordari
Position
Intern
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Bahonar blvd, Qazvin City
City
Qazvin
Postal code
Phone
+98 283336001
Fax
Email
r.barkhordari@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Rezvan Barkhordari
Position
Intern
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Bahonar blvd, Qazvin City
City
Qazvin
Postal code
Phone
+98 283336001
Fax
Email
r.barkhordari@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)