Study objective: The aim of this study was to compare gastrointestinal function after gastrectomy in patients with gastric cancer with and without nasogastric tube. Design: This study was a randomized clinical trial with two groups (experimental and control), post-test design, and not-blind. Setting and conduct: This study was conducted on 66 patients hospitalized in general surgery department of Imam Reza hospital of Mashhad. Sample size: This study was conducted on 66 patients with gastric cancer who had been operated, were randomly assigned into two groups. Inclusion criteria: having total or subtotal gastrectomy; lack of other chronic diseases (such as Renal failure, diabetics, liver disease); lack of GI bleeding and intestinal polyps. Exclusion criteria: withdraw from the study for any reason; Accidental exit of nasogastric tube after surgery. Intervention: in experimental group (n=32) nasogastric tube did had inserted by anesthesiologist immediately after surgery that its remain three days and in control group (n=34) did’t had inserted nasogastric tube. The main outcome variables in this study included: gastrointestinal function (severity of nausea, vomiting, first passage of flatus and diet tolerance). GI function in both groups was assessed 6 hours after the entrance to surgery ward from recovery room until the seventh day after surgery using a researcher-made questionnaire of gastrointestinal function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016073124845N2
Registration date:2016-08-13, 1395/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-13, 1395/05/23
Registrant information
Name
Akhtar Nejat Mohammad
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3523 2319
Email address
nejatma1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Mashhad, Vice chancellor for research
Expected recruitment start date
2015-10-28, 1394/08/06
Expected recruitment end date
2015-12-29, 1394/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Gastrointestinal Function after Gastrectomy in patients with Gastric Cancer with and without Nasogastric tube
Public title
The Effect of Nasogastric tube on Gastrointestinal Function
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having total or subtotal gastrectomy; lack of other chronic diseases (such as Renal failure, Diabetes, liver disease); lack of GI bleeding and intestinal polyps.
Exclusion criteria: withdraw from the study for any reason; accidental exit of nasogastric tube after surgery.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
University of Medical Sciences Mashhad, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
IR.MUMS.REC.94.190
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
C16.9
ICD-10 code description
Gastric cancer NOS
Primary outcomes
1
Description
gastrointestinal function
Timepoint
Up to 7 days after the day of surgery, morning
Method of measurement
self-made gastrointestinal function scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the intervention group was inserted nasogastric tube by anesthesiologist immediately after surgery and remained for three days. GI function (severity of nausea and vomiting, first passage of flatus, and diet tolerance) was assessed 6 hours after the entrance from recovery room to surgery ward until the seventh day after surgery. Data was recorded in the researcher-made questionnaire of GI function.
Category
Treatment - Devices
2
Description
Control group: in this study, no intervention was administered to the control group
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Akram Elhami
Street address
General Surgery Department, Imam Reza Hospital, Ebne Sina St, Imam Reza Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences Mashhad, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
University of Medical Sciences Mashhad, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Mashhad, Vice chancellor for research
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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Kari
Position
Master of Science
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3841 2081
Fax
Email
karim1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Hamid Chamanzari
Position
Master of Science
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3523 2319
Fax
Email
chmanzarih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Mahdi Kari
Position
Master of Science
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 915 861 4300
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)