Abdominal adhesions may be defined as abnormal connective tissues attachments between tissue, organ or both in the abdominal cavity that are normally separated. The adhesion bonds can be congenital that are infrequent causes of bowel obstruction or acquired that usually can be due to peritoneal injuries especially abdominal pelvic surgery. Post operative adhesion are the most common cause of small bowel obstruction and it happens in 93% to 100% of trans peritoneal surgery.
Also adhesive small bowel obstruction is a common cause of hospital admission and its consequences have a significant burden socioeconomically and the treatment of adhesive small bowel obstruction used fundamental portion of national health care resources for any country.
It is estimate that approximately 85% of all small bowel obstruction are secondary to adhesion, hernias, or tumors.
In terms of management of small bowel obstruction two main method are advised, surgical and non surgical methods. The most important factor to management of adhesive small bowel obstruction is detection of the patients who need emergency surgical intervention.
The patients with partial adhesive small bowel obstruction may be managed conservatively. This management must be focus on fluid resuscitation, electrolyte correction, nasogastric suction, intestinal decompression with nasointestinal tube and antibiotic therapy.
Sometimes the patients have a long hospital stay(from 1 week to 3 weeks). Some studies have done to show efficacy of non-surgical management of adhesion small bowel obstruction by sesame oil, water – soluble contrast like gastrographin. In this study, we try to evaluate the effect of oral olive oil in the management of adhesive small bowel obstruction,that approved no need any surgical intervention.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201401059936N8
Registration date:2014-04-15, 1393/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-15, 1393/01/26
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University of Medical Sciences, Shiraz, Iran
Expected recruitment start date
2013-06-25, 1392/04/04
Expected recruitment end date
2014-06-25, 1393/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of olive oil in the treatment of small bowel obstruction due to adhesions
Public title
Effect of olive oil in the treatment of small bowel obstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
Therefore inclusion criteria are:
-age older than 18 years old
-previous laparotomy (>4 weeks)
-adhesive small bowel obstruction symptoms such as abdominal pain, vomiting, abdominal distention.
-plain and upright abdominal radiography will taken from the patient which showed dilated loops in small intestine and rectum and air fluid levels in the colon.
Exclusion:
-clinical evidence of bowel strangulation including interactable pain, fever, leukocytosis
-clinical evidence of peritonitis
-pervious abdominal and pelvic radiation
-inflammatory bowel disease
-past medical history of cancer(GI cancer, pancreas cancer)
-patient who were under operation within first 24 hours after admission
-patient who refused use of nasogastric tube decompression
-strangulated hernia
-non cooperative patients such as mental retardation
-immune compromise patient, diabetic patient, history of familial hypertrigliciremia
-unconscious patient that cannot evaluated perfectly.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Siences
Street address
Shiraz University of Medical Siences, Shiraz, Iran
City
Shiraz
Postal code
-
Approval date
2013-06-25, 1392/04/04
Ethics committee reference number
91-01-01-5543
Health conditions studied
1
Description of health condition studied
bowel obstruction
ICD-10 code
K31.5
ICD-10 code description
Obstruction of duodenum
Primary outcomes
1
Description
Time to bowel obstruction
Timepoint
Every 6 hours
Method of measurement
The patient reported
Secondary outcomes
1
Description
Low Abdominal pain and distention
Timepoint
Every 6 hours
Method of measurement
Physical Examination
Intervention groups
1
Description
Intervention: in this group after admission, 150cc olive oil will be give by NG Tube.
Category
Other
2
Description
Control: Treatment is done backing of small bowel obstruction.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Colorectal Surgery, Shahid Faghihi hospital, Shiraz University of Medical Sciences
Full name of responsible person
Dr Leila Ghahramani- Assistant professor of General Surgery
Street address
Colorectal Research Center, Faghihi hospital, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi, MD
Street address
Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Colorectal Research Center, Shiraz university of medical sciences
Full name of responsible person
Dr Leila Ghahramani
Position
Colorectal flowship-assistant professor
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz university of Medical Siences, Shiraz
City
Shiraz
Postal code
Iran
Phone
+98 71 1230 6972
Fax
Email
leila_ghahramani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Colorectal Research Center, Shiraz university of medical sciences, Shiraz, Iran
Full name of responsible person
Dr Leila Ghahramani
Position
Colorectal flowship-assistant professor
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz university of medical sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
leila_ghahramni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences, Colorectal Research Center, Shiraz, Iran
Full name of responsible person
Seyed Mohammad Hosseiniasl, MD
Position
Other areas of specialty/work
Street address
Shiraz university of medical sciences, Colorectal Research Center, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
mohosseini@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)