The aim of this study is to compare improvement in Quality of life after nutritional counselling among post-op MGB patients.
Design
Prospective comparative study
Settings and conduct
The study will be conducted in General Surgery Department, Ammar Medical complex Lahore, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Patients with either gender with age group ranging between 18 to 60 years.
• Patients with bariatric surgery which was not older than 6 months.
• Patients with no fracture or limbs issue.
• No previous bariatric surgical history
• No coexisting diseases affecting the function of the limbs.
Exclusion criteria
• Patients below 18 and above 60 years of age.
• Patients with bariatric surgery more than 6 months.
• Patients with fractures of limbs.
• Pregnant ladies after a bariatric surgery were not a part of it.
• Patients who were suffering from depression and taking anti-depressant medication.
• Patients who refuse our protocol.
Intervention groups
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 MGB will encourage the demand of this minimally invasive counselling.
Main outcome variables
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 MGB will encourage the demand of this minimally invasive counselling
General information
Reason for update
Acronym
NCT
IRCT registration information
IRCT registration number:IRCT20240415061496N1
Registration date:2024-05-18, 1403/02/29
Registration timing:registered_while_recruiting
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
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
2024-05-04, 1403/02/15
Expected recruitment end date
2024-10-04, 1403/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of nutritional counselling among post-op Mini-gastric Bypass patients in terms of Quality of life.
Public title
Effectiveness of nutritional counselling among post-op Mini-gastric Bypass patients in terms of Quality of life.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients with either gender with age group ranging between 18 to 60 years.•
Patients with bariatric surgery which was not older than 6 months. •
Patients with no fracture or limbs issue.•
No previous bariatric surgical history •
No coexisting diseases affecting the function of the limbs.
Exclusion criteria:
• Patients below 18 and above 60 years of age.•
Patients with bariatric surgery more than 6 months. •
Patients with fractures of limbs.•
Pregnant ladies after a bariatric surgery were not a part of it.•
Patients who were suffering from depression and taking anti-depressant medication.• Patients who refuse our protocol.
Age
From 18 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling using lottery method.
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
ammar medical complex etjcal committee
Street address
Ammar Medical Complex, Lahore
City
lahore
Postal code
54000
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
1004
Health conditions studied
1
Description of health condition studied
bariatric surgery post op patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
. The purpose of this study is to contribute to the literature by comparing nutrtitional counselling.
Timepoint
4 months after surgery
Method of measurement
The clinical proforma (annexure-I) will collect data, fed into, assessed, and analyzed using the SPSS software version 22. Quantitative data will be described as means and standard deviations. Percentages and frequencies would be determined for qualitative data. Linear regression analysis will be performed to determine correlation of age, gender and clinical outcome
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The study will be conducted in General Surgery Department, Ammar Medical complex Lahore.
Full name of responsible person
dr amna amar butt
Street address
G8MV+X55 Ammar Medical Complex:, Jail Rd, Gulberg V, Lahore, Punjab
City
lahore
Postal code
54000
Phone
+92 335 4614376
Email
amaramarbutt123@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ammar medical complex
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?
Yes
Title of funding source
ammar medical complex
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
ammar medical complex
Full name of responsible person
dr amna amar butt
Position
bariatric dietitian
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
122,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
Full name of responsible person
prof dr maaz ul hassan
Position
general surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
ammar medical complex
City
lahore
Province
punjab
Postal code
54000
Phone
+92 300 9421994
Email
drmaaz@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
ammar medical complex
Full name of responsible person
dr amna amar butt
Position
bariatric dietitian
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
122,A,C-2, johar town lahore
City
lahore
Province
punjab
Postal code
54782
Phone
+92 335 4614376
Email
dramnaamarbutt@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
Yes - There is 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
This study was a six-month randomized control trial conducted in the General Surgery Department at Ammar Medical Complex Lahore. The study included 145 eligible participants who had undergone bariatric surgery within six months and had no prior bariatric surgery, fractures, limb issues, or coexisting diseases affecting limb function. The participants were randomly divided into two groups, one receiving nutritional counseling and the other not. The data were analyzed using SPSS software version 22, and descriptive statistics were calculated
When the data will become available and for how long
after 4 months
To whom data/document is available
to dr amna amar butt
Under which criteria data/document could be used
for publication purpose only
From where data/document is obtainable
from hospital
What processes are involved for a request to access data/document