Comparative evaluation of the effect of two different fluid therapy regimen (crystalloid VS crystalloid + colloid) on the speed of bowel motility return after gastrointestinal resection & anastomosis surgery
Further studies are needed in the field of volume and method of fluid therapy in patients having intra-abdominal surgery. This research is also in this context and its purpose is to make a comparison between two different protocols of fluid therapy during surgery, being crystalloid alone and crystalloid-colloid fluid composition during resection and anastomosis surgery of gastrointestinal tract and examining its effect on speed of gastrointestinal motility return after the surgery.
For this purpose, in a prospective randomized double blinded clinical trial study, one hundred candidates of gastrointestinal resection & anastomosis will be enrolled in the study.The chosen patients would be 18 to 60 years old and of physical class of ASA I-III. Patients with serious insufficiency in vital organs (such as heart, liver, lungs etc) and genito-urinary diseases will not be included in the study. The selected patients divided randomly in two groups will be put under the aforementioned protocols of fluid therapy (group A) crystalloid, (group B) crystalloid + colloid), during surgery and anesthesia , then their effects on speed of gastrointestinal motility return and incidence of side effects such as nausea and vomiting, leaking from anastomosis site and ileus in the postoperative period shall be evaluated and compared.
Also, patients will be prescribed with epidural pumps and local anesthetic drugs for post surgical analgesia; they are excluded from the study in the case of opioid drugs use for treatment of pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090711398N7
Registration date:2014-11-30, 1393/09/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-30, 1393/09/09
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Iran University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of two different fluid therapy regimen (crystalloid VS crystalloid + colloid) on the speed of bowel motility return after gastrointestinal resection & anastomosis surgery
Public title
Comparative evaluation of the effect of two different fluid therapy regimen on the bowel motility return after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidated for resection & anastomosis of gastrointestinal surgery; Age between 18 - 60 years old; Patients with ASA physical status class I-III; Having consent for entry.
Exclusion criteria:
Age less than 18 & more than 60; Patients with ASA physical status over than III; Pregnant females; Patients with acute or chronic uncompensated cardiac insufficiency; Known coagulopathy; Hepatic insufficiency ( 2-3 times increase in liver enzymes); Renal insufficiency ( more than 50% rise in creatinine); Known gastroparesis & bowel motility disorders; Fatty patients with BMI over than 35
Age
From 18 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Tehran University of Medical Sciences
Street address
Main University building, Qods St. Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2013-09-07, 1392/06/16
Ethics committee reference number
1190/130/د/92
Health conditions studied
1
Description of health condition studied
Ileus
ICD-10 code
K-56.0
ICD-10 code description
Paralytic ileus
Primary outcomes
1
Description
Ileus
Timepoint
Day after intervention
Method of measurement
Based on questionnare
Secondary outcomes
1
Description
Nausea & Vomiting
Timepoint
Day after intervention
Method of measurement
Based on questionnaire
2
Description
Anastomosis leak
Timepoint
Day after intervention
Method of measurement
Based on clinical chart documents
3
Description
Dehiscence
Timepoint
From day after intervention
Method of measurement
Based on clinical observation
Intervention groups
1
Description
Intervention group: For the fluid therapy of the patients of this group, we will use a combination of crystalloid & colloid fluids. Where, colloid will be used to replace the third space loss and bleeding until reaching the transfusion limit, and crystalloid for the replacing the rest of the fluid needs.
Category
Treatment - Other
2
Description
In control group:Total calculated fluid need of patients will be replaced with crystalloid (normal saline & ringer lactate in 50:50 ratio)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Hosein Reza Dehghan MD.
Street address
Anesthesiology department, Firoozgar hospital, Beh-afarin St, Karim Khan Av.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi MD.
Street address
Hemmat highway, between Chamran & Sheykh Fazlollah
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hosein Reza Dehghan MD.
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Firoozgar Hospital, Beh-afrin St, Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
dhoseinreza@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Anesthesiology Department, Firoozgar Hospital, Beh-afarin St, Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
mrghodrati@yahoo.comghodrati.mr@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Reza Dehghan MD.
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Anesthesia department, Firoozghar hospital, Beh-afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
Fax
Email
dhoseinreza@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)