The aim of this study was to investigate the impact of nutritional counselling on the quality of life of patients who have undergone Sleeve Gastrectomy.
Design
Randomized Control Trial (RCT) was performed utilized a simple random sampling using lottery method. The study compared the quality of life of post-op patients that have undergone sleeve gastrectomy and who received nutritional counselling with those who did not receive any counselling.
Settings and conduct
The study was conducted in the General Surgery Department at Ammar Medical Complex Lahore and had a duration of 6 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The study's inclusion criteria included male and female patients aged between 18 to 60 years who have undergone bariatric surgery within 6 months, with no prior bariatric surgery, fractures or limb issues, and no coexisting diseases that affect limb function. This criteria helped in reducing confounding variables
Exclusion criteria: Patients under the age of 18 or older than 60, those with a history of bariatric surgery that lasted longer than six months, those with limb fractures, pregnant women with a history of bariatric surgery, those taking antidepressants, and those who refused to adhere to the study's protocol were all excluded from the study. These requirements helped to accurately represent the study's target group and to reduce any potential confounding variables that might have had a detrimental impact on the study's findings.
Intervention groups
A crucial component of sleeve gastrectomy is nutritional counselling, which assists patients in adjusting to dietary changes and achieving the best possible results in terms of weight loss and health
Main outcome variables
effectiveness of nutritional counselling
General information
Reason for update
Acronym
rct
IRCT registration information
IRCT registration number:IRCT20240415061496N2
Registration date:2024-06-08, 1403/03/19
Registration timing:registered_while_recruiting
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Dr amna amar butt
Name of organization / entity
Ammar medical complex
Country
Pakistan
Phone
+92 335 4614376
Email address
amaramarbutt123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-03, 1403/03/14
Expected recruitment end date
2024-10-03, 1403/07/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness Of Nutritional Counselling Among Post-Op Sleeve Gastrectomy Patients In Terms Of Quality Of Life.
Public title
Effectiveness Of Nutritional Counselling Among Post-Op Sleeve Gastrectomy Patients In Terms Of Quality Of Life
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The study's inclusion criteria included male and female patients aged between 18 to 60 years who have undergone bariatric surgery within 6 months, with no prior bariatric surgery, fractures or limb issues, and no coexisting diseases that affect limb function. This criteria helped in reducing confounding variables
Exclusion criteria:
Patients under the age of 18 or older than 60, those with a history of bariatric surgery that lasted longer than six months, those with limb fractures, pregnant women with a history of bariatric surgery, those taking antidepressants, and those who refused to adhere to the study's protocol were all excluded from the study. These requirements helped to accurately represent the study's target group and to reduce any potential confounding variables that might have had a detrimental impact on the study's findings
Age
From 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
145
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be based on six-month randomized control trial conducted in the General Surgery Department at Ammar Medical Complex Lahore with 145 eligible participants who were randomly divided into two groups. will be selected through lottery methord
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
interventional
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee of Ammar Medical Complex, Lahore
Street address
G8MV+X55 Ammar Medical Complex:, Jail Rd, Gulberg V, Lahore, Punjab
City
lahore
Postal code
54000
Approval date
2024-06-03, 1403/03/14
Ethics committee reference number
10006
Health conditions studied
1
Description of health condition studied
sleeve gastrectomy patients
ICD-10 code
E90*
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere
Primary outcomes
1
Description
Any difference in results between the groups has the potential to enhance current practice and patient life significantly. The purpose of this study is to contribute to the literature by comparing nutritional counselling. In nutritional counselling group, better results with the sleeve gastrectomy will encourage the demand of this minimally invasive counselling
Timepoint
4 months
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: While the other group in the trial did not receive any nutritional counselling, one group in the study received nutritional counselling for six months after surgery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ammar Medical Complex, Lahore
Full name of responsible person
dr amna amar butt
Street address
110,A,C-2, johar town lahore
City
lahore
Postal code
54782
Phone
+92 335 4614376
Email
amaramarbutt123@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ammar Medical Complex, Lahore
Full name of responsible person
dr maaz ul hassan
Street address
110,A,C-2, johar town lahore
City
lahore
Postal code
54782
Phone
+92 335 4614376
Email
amaramarbutt123@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
educational research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ammar Medical Complex, Lahore
Full name of responsible person
dr amna amar butt
Position
bariatric dietitian
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
110,A,C-2, johar town lahore
City
lahore
Province
punjab
Postal code
54782
Phone
+92 335 4614376
Email
dramnaamarbutt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ammar Medical Complex, Lahore
Full name of responsible person
dr maaz ul hassan
Position
general surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
110,A,C-2, johar town lahore
City
lahore
Province
punjab
Postal code
54782
Phone
+92 335 4614376
Email
amaramarbutt123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ammar Medical Complex, Lahore
Full name of responsible person
dr amna amar butt
Position
bariatric dietitian
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
110,A,C-2, johar town lahore
City
lahore
Province
punjab
Postal code
54782
Phone
+92 335 4614376
Email
amaramarbutt123@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effectiveness of nutritional counselling among post-op Mini-gastric Bypass patients in terms of Quality of life
When the data will become available and for how long
after 6 months
To whom data/document is available
to the research invesigator
Under which criteria data/document could be used
Data will be gathered using the meticulously created clinical proforma, which were then entered into, evaluated, and analyzed using the SPSS programmer version 22. Means and standard deviations were used to describe quantitative data.
From where data/document is obtainable
dramnaamarbutt@gmail.com
What processes are involved for a request to access data/document