Protocol summary

Summary
The aim of this study was to determine the effect of nicotine patch on reducing postoperative ileus and consequently its use in the clinic to accelerate the return of gastrointestinal activity and to reduce hospitalization time, thereby saving hospital costs and reducing the risk of getting hospital infections due to Long-term admissions. The inclusion criteria for patients aged 15 to 45 years who were diagnosed with appendicitis with acute appendicitis and were excluded from the study of peripheral appendicitis and cardiovascular, respiratory, diabetes, hypothyroidism, hypoparathyroidism ; Electrolyte disturbances; neuromuscular diseases; Tyad to tobacco and drugs, according to the patients report.The study population consisted of 80 patients who referred to Fatemi Hospital in Ardabil in 2016 and 2017 who were diagnosed with appendicitis as an appendicitis candidate. These 80 patients were assigned to control and intervention groups. In an intervention group of 40, one hour Before the start of the operation, 15 mg nicotine patch was applied to the arm and after the initiation of intestinal sounds and gas and fecal excretion, and fluid and solids intake and duration of hospitalization, were examined and in the control group 40 patients were non nicotinic patches that were attached to the arm and examined for signs mentioned in above. 458/5000

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082535889N1
Registration date: 2017-10-04, 1396/07/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-04, 1396/07/12
Registrant information
Name
Javid Mansoori
Name of organization / entity
Ardebil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3375 0281
Email address
j.mansoori@stud.arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ardabil University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-09-16, 1396/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nicotine Patch in reducing post Appendectomy Illeus
Public title
Effect on nicotine glue in increasing gastric mucus movements after appendectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for entering the study: Age over 15 years of age and under 45 years of age Applicant for appendectomy Exit criteria: Perforated appendicitis; Cardiovascular disease; respiratory disease; diabetes; hypothyroidism; hypoparathyroidism; electrolyte disorders; neuromuscular diseases; addiction Cigarettes and hookahs and drugs are based on patients' reports
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee Of Ardabil University Of Medical Sciences
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR. Arums.rec.1395.58

Health conditions studied

1

Description of health condition studied
Acute appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis

Primary outcomes

1

Description
Bowel Sounds
Timepoint
Every 2 Hour
Method of measurement
Hearing of Bowel sound by stetoscope

2

Description
Flatus passing
Timepoint
Each 2 hours
Method of measurement
Asking from patients

3

Description
Defication
Timepoint
Each 2 hours
Method of measurement
Asking from patients

4

Description
Duration of admission
Timepoint
After hospital discharge of patients
Method of measurement
Hours of hospitalization

5

Description
Tolerance of watery foods
Timepoint
start eating of watery foods
Method of measurement
Ask the patient about nausea and vomiting

6

Description
Tolerance solid foods
Timepoint
Start solid foods
Method of measurement
Ask the patient about nausea and vomiting

Secondary outcomes

empty

Intervention groups

1

Description
Nicotine patch is fasted 15 milligrams half an hour before appendectomy surgery and the variables are recorded 2 hours after the operation.
Category
Treatment - Drugs

2

Description
Non-nicotine patch is fastened to the arm for half an hour before surgery and measurement of variables is performed 2 hours after the operation
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
The Fatemy Hospital OF Ardebil City
Full name of responsible person
Javid Mansoori
Street address
Ardebil, Sarein Station, Imam Khomeini Street (RA), not reaching Shariati Square, Fatemi Educational and Therapeutic Center
City
Ardebil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Ardabil University of Medical Sciences
Full name of responsible person
Dr Hadi Piri Dogahe
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Javid Mansoori
Position
Medical student
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 914 351 8741
Fax
Email
j.mansoori@stud.arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Ahmad Arabzadeh
Position
Specialist in General Surgery
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province
City
Ardabil
Postal code
Phone
+98 912 415 2242
Fax
Email
A.arabzade@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Javid Mansoori
Position
Medical Student
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province
City
Postal code
Phone
+98 914 351 8741
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...