Least Significance Difference:Biostatics and Research Methodology
prof.dr.manju maam ppt (3).pptx
1. “ASSESSMENT OF QUALITY-OF-LIFE (QOL) IN
PATIENTS UNDERGOING CONVENTIONAL
VENTRAL HERNIOPLASTY’’
Candidate- Dr. Souparno Mandal
1st year post graduate trainee, Dept Of General Surgery
Guide- Prof .Dr Manju Banerjee, Department of General Surgery
2. AIMS AND OBJECTIVES
To evaluate improvement in post-operative quality of life of patients of ventral hernia who have undergone open
polypropylene mesh hernioplasty.
Specific objectives of my study are to
A. evaluate improvement in: -
1) Physical pain
2) Functional ability: - dressing, walking, climbing stairs, squatting etc.
3) Cosmesis
4) Psychological agony
B. To evaluate any Post operative complications if any
3. METHODOLOGY
1. Study design – Observational prospective study
2. Study timelines- June 2023- December 2024
3. Place of study- Department of General Surgery JIMSH, Buita, Budge-Budge, Kolkata 700137
4. Period of study- 18 months
5. Study population – All patients admitted for ventral hernioplasty during the study period with fulfilment of the study population criteria.
6. Sample size- By applying the statistical formula i.e., 1.96^2pq/l^2, the minimum number of sample size with 95% confidence interval and
marginal error 5% should be ~31. Where ‘p’ = 0.02 and ‘q = (1-p) =0.98 as Prevalence=2%. I would like to decrease the marginal error from
5% to 3.5% to make the study more significant. With 3.5% marginal error, my sample size should be ~ 62. R. Le Huu Nho et all conducted a
study on ventral and incisional hernia. As per that study prevalence is 2%.
4. 7.Inclusion criteria
All elective patients having ventral hernias who will be undergoing open polypropylene mesh hernioplasty in Department of General
Surgery of the institute
1. Age 18years and above
2. ASA score up to III
3. Patients who give consent for prosthetic repair
4. Patients who will be available for follow up
8. Exclusion criteria:
1. Age less than 18 years
2. ASA score>III
3. Patients unwilling to undergo prosthetic repair
4. Patients who will not be available for follow-up
Data collection and interpretation-from the OPD and BHT of the patient
Data collection:
A. Name
B. Age
C. Sex
D. Occupation
E. Address
F. Religion
G. Date of admission
H. Chief complaints
I. History of present illness
J. History of past illness
K. Comorbidity, History of tuberculosis, thyroid disorder
5. L. PERSONAL HISTORY
1. Diet- Veg / non-veg
2. Urine- Normal / Polyuria
3. Sleep- Sound / Disturbed
4. Addiction to smoking or alcohol – Yes / No
5. Family History Of tuberculosis – Yes / No
6. Allergy history
7. Any skin conditions
M. Examination
• i. General Examination: -
1. Build - well / mod / poor
2. Decubitus –
3. BP –
4. PR –
5. Respiration –
6. Temperature – Normal / Raised
7. Pallor - Yes / No
8. Icterus –
9. Cyanosis –
10. Clubbing –
11. Oedema –
12. Lymph nodes –
13. Neck veins – Normal / Raised
14. Body weight
15. Height
16. BMI
6. • ii. Abdominal examination and examination of hernia site – number, gap in the scar, tone of abdominal muscles, position of rectus abdominis.
• iii. Systemic examination
• 1. Cardiovascular system
• 2. Respiratory system
• 3. Neurological system
• N. HerQLes” (Hernia related Quality of Life survey) form to be filled up on date of first attendance.
• 2. INVESTIGATION:
• a. Blood- Complete Blood count,
• Blood urea,
• serum creatinine,
• blood sugar assessment,
• blood coagulation profile,
• Lipid profile,
• Liver function test,
• Serology (HIV, Hepatitis B and Hepatitis C)
• b. Chest x-ray: -
• Postero-Antero view
• c. Electrocardiography,
• d. Ultrasonography of abdomen and anterior abdominal wall
• e. CT- as per requirement
7. • STUDY TOOLS: - Bed head ticket,outdoor ticket, Predesigned proforma, adapted from “HerQLes” (Hernia related Quality of Life
survey) will be used for data collection by doing serial interview with the patients. The HerQLes is a questionnaire which has 12 items.
By this tool we can assess functional improvement of abdominal wall after ventral hernia repair. Some modification is made with respect
to sociodemographic distribution of our patient population.
• STUDY TECHNIQUE: - At first, the purpose of this study will be explained in patient’s own language. Patients will be informed that
they can refuse to participate at any point and that will not affect in management. Based on HerQLes data will be collected preoperatively
and then every day till 7th post-operative day and then 1st and 4th month of follow up. Patient’s outdoor ticket, bed head ticket and
discharge certificates will be studied thoroughly while collecting data.
8. Hernia Related Quality Of
Life Survey (HerQLes) Tool
Score and Interpretation
9 – BEST OUTCOME
10-22- GOOD OUTCOME
23-35- MODERATELY BAD OUTCOME
36-45- POOR OUTCOME
LOWER THE SCORE BETTER THE PROGNOSIS,HIGHER THE SCORE POORER THE OUTCOME
9. • Consent Form
*PART 1 of 2
• INFORMATION FOR PARTICIPANTS OF THE STUDY
• PARTICIPANT INFORMATION SHEET
• Instructions - This is the patient information sheet. It should address the participant of this study. Depending upon the nature of the individual project, the details
provided to the participant may vary. A separate consent form for the patient/test group and control (drug/procedure or placebo) should be provided as
applicable. While formulating this sheet, the investigator must provide the following information as applicable in a simple language in English and Bengali which
can be understood by the participant
• Title of the project- Assessment of quality of life (QOL) in patients undergoing conventional Ventral hernioplasty.
• Name of the investigator/guide- Dr.Souparno Mandal/ Prof. Dr. Manju Banerjee, Head of department, Department of General Surgery.
• Purpose of this project/study- Assessment of quality of life (QOL) in patients undergoing conventional Ventral hernioplasty.
• Procedure/methods of the study- An observational prospective study.
• Expected duration of the subject participation- : June 2023 to December December 2024.
• The benefits to be expected from the research to the participant or to others and the post trial responsibilities of the investigator
• Any risks expected from the study to the participant - No
• Maintenance of confidentiality of records- Yes
• Provision of free treatment for research related injury- Yes
• Compensation of the participants not only for disability or death resulting from such injury but also for unforeseeable risks- Since it is an observational prospective
study any risk or study related injury involving the patient is not expected, hence compensation issue does not arise.
• Freedom to withdraw from the study at any time during the study period without the loss of benefits that the participant would otherwise be entitled to - Yes
• Possible current and future uses of the biological material and of the data to be generated from the research and if the material is likely to be used for secondary
purposes or would be shared with others- Yes
• Address and telephone number of the investigator and co-investigator/guide – Souparno Mandal, 9699879775 dr.souparnomandal@gmail.com
• Prof. Manju Banerjee, mob no- 833597779, manjubanerjee2022@gmail.com
• The patient information sheet must be duly signed by the investigator.
10. • CONSENT FORM
• PART 2 of 2- Participant consent form
• Protocol Study number:
• Patient identification number for this study:
• Title of the project: ASSESSMENT OF QUALITY-OF-LIFE (QOL) IN PATIENTS UNDERGOING CONVENTIONAL VENTRAL HERNIOPLASTY
• Name of Principal investigator: Souparno Mandal
• Tel. No(s) - 9699879775
• The contents of the information sheet dated that was provided have been read carefully by me / explained in detail to me, in a language that I comprehend, and I have fully understood the contents. I confirm that
I have had the opportunity to ask questions.
• The nature and purpose of the study and its potential risks / benefits and expected duration of the study, and other relevant details of the study have been explained to me in detail. I understand that my
participation is voluntary and that I am free to withdraw from the study at any time, without giving any reason, without my medical care or legal right being affected.
• I agree to take part in the above study
• Signatures / Left Thumb Impression)
• Date:
• Place:
• i understand that the information collected about me from my participation in this research and sections of any of my medical notes may be looked at by responsible individuals from JIMSH, Budge budge. I give
permission for these individuals to have access to my records.
•
• I agree to take part in the above study
• --------------------------------------------
• (Signatures / Left Thumb Impression)
Name of Participant: Son/Daughter/spouse of:
• Complete postal address:
• This is to certify that the above consent has been obtained in my presence.
• -------------------------------------------- ………………………………….
• Signatures of the Principal Investigator Signatures of the Witness
•
Date-
Place-
-
11. I, Mr. / Mrs. ___________________________ have been informed about all the aspects of the study, by the investigator verbally in a language
known to me. I have been given the opportunity to discuss all aspects of the study, to ask questions and hereby consent to participation in the
study.
I understand that my participation in this study is voluntary, and I am free to withdraw at any time, without having to give any reason and
without my rights and privileges being affected.
I understand that my data will be kept confidential, but the individuals appointed by principal investigator, ethics committee of the institution
where the study is being conducted and the regulatory authority will have access to the records both in respect of the current study and future
research that may be conducted in relation to it. Even if I withdraw, I agree to this access. However, I understand that my identity will not be
revealed, and confidentiality of the information will be maintained.
I agree to take part in this study voluntarily.
Signature of participant / Left thumb impression of participant:
Date:
CONSENT FORM