Protocol

1. A STUDY ON PERI OPERATIVE
RISK FACTORS AND THEIR
ASSOCIATION WITH POST
OPERATIVE PANCREATIC
FISTULA FOLLOWING DISTAL
PANCREATECTOMY
Dr Prashanth Venkatean
SURGICAL
GASTROENTEROLGY
Guide: DR PRAKASH K
Co guide: DR VIPIN IS

3. AIM & OBJECTIVES:
• Primary Objective: To analyze and estimate the association between potential
risk factors and Post operative Pancreatic Fistula following Distal
Pancreatectomy.
• Secondary Objective: To develop a risk prediction model based on the associated
risk factors found in this study.

4. Sample Size
A study conducted by Charles Vanbrugghe et al reports that the prevalence of
Pancreatic fistula was 31% and considering a precision of10% and 95% confidence
interval, the sample size is calculated as
N = Z21-α/2 * p * (1 - p) / d2
Z1-α/2 - two tailed probability for 95% confidence interval = 1.96
p (%) - prevalence of = 0.31
d (%) - precision or allowable error for = 0.10
N = 1.96^2 * 0.31 * (1 - 0.31) / 0.10^2
N = 82.17
Thus the minimum sample size required for the study is 82

5. MATERIALS & METHODS
• Study population- All patients with benign or malignant tumors of the
body or tail of pancreas planned for or underwent Distal
Pancreatectomy
• Study design - Observational study ( bidirectional)

6. • Inclusion Criteria
• All patients with benign or malignant tumors of the body or tail of
pancreas planned for Distal Pancreatectomy

7. CONDUCT OF THE STUDY
• Study period- 8 years (from June 2017 to April 2025). 5 years
Retrospective and 3 years prospective.
• Study setting - Patients who underwent and will undergo Distal
pancreatectomy in Department of Surgical Gastroenterology, Aster
Medcity.
• Data collection methods- Patients’ information will be retrospectively
and prospectively collected from electronic medical records.

8. DATA ANALYSIS PLANDATA ANALYSIS PLAN
Data Analysis plan
• Descriptive statistics for baseline characteristics of the data
• Qualitative variables as counts and percentages
• Quantitative variables as mean and standard deviation or median
and IQR
• A Chi square test or Fisher exact test for association of risk factors
with Post Operative pancreatic fistula.
• Logistic regression analysis for Significant risk factors.
• P value < 0.05 – statistically significant
• All data entered in Microsoft excel version 2019 and analyzed in
SPSS version 20.0

9. DATA COLLECTION FORM :
• Name : Age : Sex: Aster ID : DOA :
• Diagnosis :
• DOS :
• BMI :
• Grade of Pancreatic Fistula:
• ASA grade :
• Diabetes :
• History of Previous Abdominal Surgery
• Preoperative Lab values
 Serum Albumin
 Neutrophil to Lymphocyte ratio
 Prognostic Nutritional Index - [(10 x Serum albumin) + (0.005 x Total
lymphocyte count)]

10. • Pre operative Radiological factors
 Sarcopenic Obesity – SMI(Skeletal Muscle Index)
 MPDD – Main Pancreatic Duct diameter
 PT – Pancreatic Thickness
 PT/MPDD ratio
• Post operative Factors
• Pathology of Tumor
• Tumor Size

11. • Intraoperative factors
 Laproscopic or open
 Site of Transection
 Method of Transection
 Choice of Staplers
 Splenectomy vs Spleen preserving
 Multivisceral Excision
 Total Surgery Time
 Blood loss

12. Subject identification number for this study __________________________________
Title of the Study: _____________________________________________________
Name of the Principal Investigator ____________________ Tel. No.____________
• I have received information on the above study .
• I have been given the chance to discuss the study and ask questions.
• I am aware that my participation is voluntary.
• I understand that I may withdraw at any time without this affecting my future care.
• 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 persons (ethics committee members / regulatory authorities). I permit these individuals to have access to my records.
• I understand that my identity will not be revealed in any information released to third parties or published.
• I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s)
• I understand I will receive a copy of the informed consent form.
• I consent to take part in the study
Signature / Thumb Impression of subject Date of signature ______________________________
Printed name of the subject in capitals ___________________________
INFORMED CONSENT FORM

13. സമ്മതപത്തം
ക്രമ നമ്പർ
പഠനത്തിന്റെ പപര്:
ഗപേഷരയുറെ പപര്: പ ോൺ നമ്പർ:
ഈ പഠനറത്ത രുെിച്ചുള്ള േിേരം എനിക്ക് ലഭിക്കുരയും അത് ഞോൻ മനസ്സിലോക്കുരയും റെയ്തിട്ടുണ്ട് . പഠനറത്ത രുെിച്ച
സംശയങ്ങൾ പെോദിയ്ക്കോൻ എനിക്ക് അേസരം ലഭിച്ചിട്ടുണ്ട് . പഠനത്തിന്റെ ഏതു ഘട്ടത്തിലും എനിക്ക് ഇതിൽ നിന്ന്
പിൻേോങ്ങോൻ ഉള്ള അേരോശം ഉറണ്ടന്നും അത് എന്റെ തുെർ െിരിത്സറയ ഒരു തരത്തിലും ബോധിക്കില്ല എന്നും ഞോൻ
മനസിലോക്കുന്നു . ഈ പഠനത്തിൽ പറെെുക്കുേോനോയി ഞോൻ പൂർണ്ണമോയും സവമനസ്സോറല സമ്മതം നൽരുന്നു .
പറെെുക്കുന്ന ആളുറെ പപര് :
പറെെുക്കുന്ന ആളുറെ ഒപ്പ്:
തിയതി :
INFORMED CONSENT FORM

14. • All the laboratory and radiological investigations done, are even otherwise indicated in the
management of patients with benign or malignant tumours of Distal Pancreas.
• No additional cost for the patient
ETHICAL CONCERNS

15. Questionnaire for investigators
 Will potential participants be asked to give informed consent in
writing and will they be asked to confirm that they have received and
read the information about the study?---- Yes
 Has information (written and oral) about the study been prepared in
an appropriate form and language for potential participants? If so
show that here --- Yes
 At what point in the study will this information be offered?– at the
first contact with the study subject

16. • How have ethical concerns arising from data collection been
addressed- if any-- Yes
• All the laboratory and radiological investigations done, are even
otherwise indicated for patients undergoing Distal pancreatectomy
for Distal pancreas tumours.
• No additional cost for the patient
• What arrangements have been made to preserve confidentiality for
the participants or those potentially affected?
• The information related to the patients identity will not be
disclosed at any point in the study.
• Is the research being funded/sponsored?-- No

17. THANK YOU