Evaluation of the effectiveness of sugar-free chewing gum in reducing the snaking in patients with a history of sleeve gastrectomy and classic gastric bypass
Evaluation of the effect of chewing sugar-free gum on the snaking after gastrectomy sleeve and classic bypass
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 100 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
In this clinical trial with a control group, which is performed on 116 patients complaining of snaking after obesity surgery, patients refer to Rasool-e Akram Obesity Center in Tehran and are divided into two groups: sugar-free gum and the control group. Statistical analyzer and outcome assessor are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of Gastric Sleeve or classic bypass, Snaking after gastric sleeve or classic bypass, consent to participate in the study. Exclusion criteria: Age more than 60 years, history of dental problems resulting in disability to chew properly
Intervention groups
Intervention group: It is recommended to chew sugar-free gum regularly and four hours a day in the form of four one-hour intervals between meals to the patients for two months. Control group: Do not receive chewing gum.
Main outcome variables
Reducing the snaking; Weight loss after bariatric surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190128042520N3
Registration date:2021-11-02, 1400/08/11
Registration timing:prospective
Last update:2021-11-02, 1400/08/11
Update count:0
Registration date
2021-11-02, 1400/08/11
Registrant information
Name
Mohammad Kermansaravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 5451
Email address
kermansaravi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-12-23, 1401/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of sugar-free chewing gum in reducing the snaking in patients with a history of sleeve gastrectomy and classic gastric bypass
Public title
The effect of sugar-free chewing gum on reducing snaking after weight loss surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
History of Gastric Sleeve or classic bypass
Snaking after gastric sleeve or classic bypass
Consent to participate in the study
Exclusion criteria:
Age more than 60 years
History of dental problems resulting in disability to chew properly
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is used; Blocking should be used to balance the number of samples assigned to each of the study groups. In this way, because we have two intervention groups, equal blocks of 4 are used and we create all possible blocks of 4, and then we randomly select a number of blocks with Excel software. Because the number of sample sizes in this study is 116 people (58 people in each group), 15 blocks of 4 using Excel software are needed. Also, in order to observe the concealment of the randomization sequence, this sequence is given to a person outside the study who has no involvement in the study, who announces the sequence of patients in the study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor is unaware of the allocation of patients in the two groups and the statistical analyst receives the groups as codes A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ehtics Committee of Iran University of Medical Sciences
Street address
Fifth floor, Headquarter., Iran university of Medical Sciences., between Chamran and Sheikh Fazlollah., Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.IUMS.REC.1400.009
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Snaking changes
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Interview with patients
Secondary outcomes
1
Description
Weight change
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Scale
Intervention groups
1
Description
Intervention group: Intervention group is recommended to chew sugar-free gum (Biodent company of Iran) regularly and four hours a day in the form of four one-hour intervals between meals to the patients for two months