Lecture notes for UG MBBS

1. Learning Objectives
• At the end of this session the learner
will be able to describe the “The
principles and steps of research in
clinical surgery.”

2. Research in clinical surgery
• Research is "creative and systematic work
undertaken to increase the stock
of knowledge.”

3. Basic principles of research
1. Inductive – Collect data and try to find the
mechanism -Newton.
2. Deductive –Form a hypothesis and match
with observations
The clinical research plan is based directly on
inductive Newtonian ideas for proceeding
from observation to inference.

4. Why to do research?
1. To advance knowledge for the good of
society.
2. To improve the health of people worldwide
3. To find better ways to treat and prevent
disease.
The high quality of medical care we enjoy
today is built upon years of effort by
physicians, physician-scientists, PhDs, and
other medical professionals investigating the
causes of and potential treatments for disease.

5. Types of research in Surgery
• Basic science research(Fundamental Research)-
to increase understanding of fundamental life
processes
• Clinical research- important questions of normal
function and disease using human subjects.
• Translational Research takes a result from basic
or fundamental science and studies its
applicability in the clinical or human situation.
• Applied Research seeks the specific knowledge
necessary to improve the treatment of a particular
disease.

6. What is clinical research?
1. Clinical research is the branch of scientific
endeavor devoted to the evaluation of
patients and the analysis of associated
health outcomes.
2. These analyses serve to identify potential
areas for change in physician or patient
behavior or in clinical processes.
3. The findings will be used to modify
clinical practice to achieve better
outcomes.

7. Clinical Research
Clinical research involves interaction with -
1. Patients
2. Diagnostic clinical materials or data
3. Populations

8. Clinical Research Areas
• Disease mechanisms;
• Translational research
• Clinical knowledge, detection, diagnosis, and
natural history of disease
• Therapeutic interventions, including clinical
trials
• Prevention and health promotion
• Behavioral research
• Health services research
• Epidemiology
• Community-based and managed care-based
research.

9. Evidence Based Medicine.
• Evidence-based medicine is the foundation
on which clinical research is built and is the
explicit use of scientific data in decision
making for clinical care.
• Approach to medical practice intended to
optimize decision-making by emphasizing
the use of evidence from well-designed and
well-conducted research.
• EBM evaluates the answers to research
question by meta-analysis of all research
studies done on the research question

10. Evidence Based Medicine.
• Level IA: evidence obtained from a meta-
analysis of multiple, well-conducted, and well-
designed randomized trials. Randomized trials
provide some of the strongest clinical evidence,
and if these are repeated and the results combined
in a meta-analysis, then the overall results are
assumed to be even stronger.
• Level IB: evidence obtained from a single well-
conducted and well-designed randomized
controlled trial. The randomized controlled
study, when well-designed and well-conducted, is
a gold standard for clinical medicine.
•

11. Evidence Based Medicine.
• Level IIA: evidence from at least one well-designed and
executed non-randomized controlled study. When
randomization does not occur, there may be more bias
introduced into the study.
• Level IIB: evidence from at least one well-designed case-
control or cohort study. Not all clinical questions can be
effectively or ethically studied with a randomized
controlled study.
• Level III: evidence from at least one non-
experimental study. Typically level III evidence would
include case series as well as not well-designed case-
control or cohort studies.
• Level IV: expert opinions from respected authorities on the
subject based on their clinical experience.
:

12. Evidence Based Medicine.
The evidence is commonly stratified into six
different levels:
• Level IA:
• Level IB:
• Level IIA:
• Level IIB:
• Level III:
• Level IV:

13. Research Question
• A research question pinpoints exactly what
you want to find out in your work. A good
research question is essential to guide
your research .
•

14. Research Question
Research questions should be:
1. Focused on a single problem or issue
2. Researchable using primary and/or secondary
sources.
3. Feasible to answer within the timeframe and
practical constraints
4. Specific enough to answer thoroughly
5. Complex enough to develop the answer over the
space of a paper or thesis
6. Relevant to your field of study and/or society
more broadly

15. Research Question:Examples
• What is the gate to knife time of our
hospital?
• Does eating sour increases the SSI rate?
• Which is better 2ml or 4ml. perkg bodyweight per
percent of burn in burn resuscitation?
• Does postoperative antibiotics reduce SSI rate?
• What are the dignoses attending our opd in the
year 2024?
• Are the members of surgical team scrubbing for
3minutes?

16. Steps
• Louis Pasteur established the “IMRD” format for
reporting scientific information:
1. Introduction
2. Methods
3. Results
4. Discussion

17. Steps of clinical research
1. Background and objectives
2. Literature review
3. Trial design
4. Ethical approval
5. Funding
6. Register in registry.
7. Recruit participants
8. Data collection
9. Analysis
10. Conclusions
11. Discussion
12. Publish

18. Study Designs
• Randomized controlled trial (RCT):
• Observational studies
• Retrospective (Data Mining)
• Prospective
• Interventional studies
• Cohort study
• Case-control study
• Cross-sectional study
• Case series/case report
• Multicenter trials
• Systematic review and meta-analysis

19. Case-control Study
• A case-control study is a type of
observational study commonly used to look
at factors associated with diseases or
outcomes.
• We compare two existing groups differing
in outcome ie. subject of interest.
• Except for the subject of interest the
participants of two groups are otherwise
similar.

20. Case-control Study
• The case-control study starts with a group
of cases, which are the individuals who
have the outcome of interest.
• The researcher then tries to construct a
second group of individuals called the
controls, who are similar to the case
individuals but do not have the outcome of
interest.

21. Case-control Study
• The researcher then looks at historical
factors to identify if some exposure(s) is/are
found more commonly in the cases than the
controls.
• If the exposure is found more commonly in
the cases than in the controls, the researcher
can hypothesize that the exposure may be
linked to the outcome of interest..

22. Cohort Study
• Cohort studies are types of observational
studies in which a cohort, ie. a group of
individuals sharing some characteristic, are
followed up over time, and outcomes are
measured at one or more time points.
• Cohort studies can be classified as
prospective or retrospective studies,

23. •

24. Principles of research
1. Informed consent
2. Safety and ethical considerations
3. Validity and reliability
4. Statistical significance
5. Transparency and openness
6. Conflict of interest
7. Bias
8. Validity
9. Sampling
10. Blinding
11. Randomisation
12. Study protocol
13. Peer review
14. Plagiarism

25. Bias
• An error which tends to produce results or
conclusions that differ systematically from
the truth.
•

26. Types of Bias
1. Selection Bias
2. Classification bias, also aka measurement
or information bias
3. Confounding bias is a spurious association
made between the outcome and a factor
that is not itself causally related to the
outcome.
4. Lead-time bias
5. Publication bias

27. Validity
• Internal validity examines whether the study
design, conduct, and analysis answer the
research questions without bias.
• External validity examines whether the
study findings can be generalized to other
contexts.

28. Plagiarism
• Plagiarism is the fraudulent representation
of another person's language, thoughts,
ideas, or expressions as one's own original
work.
• Not citing (acknowledging) the source is
also plagiarism.
• It is a serious ethical offense.
• Punishable.

29. Types of Plagiarism
• Direct Plagiarism. Direct plagiarism is the
word-for-word transcription of a section of
someone else's work, without attribution
and without quotation marks. ...
• Self Plagiarism. ...
• Mosaic Plagiarism. ...
• Accidental Plagiarism.

30. Conflict of Interest
• Conflicts of interest may be defined as
“circumstances that create a risk that
professional judgments or actions regarding
a primary interest will be unduly influenced
by a secondary interest”
• Primary interest is research itself.
• Secondary interest is financial gain or
career advancement of researcher.

31. Title
• Conventional versus Prophylactic Mesh
placement technique of midline
laparotomy: A comparative study.
Dr. Kameshwar
Assistant Professor
-Dr. Pradeep Pande
Associate Professor
Deptt. Of Surgery

32. Abstract
Background and Objectives
• The midline laparotomy is frequently used
for abdominal surgeries.
• Main complication is incisional hernia.
• The objective of this study is to compare
Mesh Placement Technique with
conventional Mass closure technique in
preventing the incisional hernia

33. Introduction
• Introduction: The median laparotomy is
frequently used by abdominal surgeons to
gain rapid and wide access to the abdominal
cavity with minimal damage to nerves,
vascular structures and muscles of the
abdominal wall. However, incisional hernia
remains the most common complication
after median laparotomy, with reported
incidences varying between 2-20%1.

34. Introduction
• Median laparotomies and incisional hernias
have been subject of investigation for a long
period of time already. Although a lot is
known about patient related risk factors and
suture materials, technical risk factors such
as suture techniques have not been
investigated thoroughly 2.

35. Materials and Methods
Trial Design
• This trial has been designed as a
prospective, double-blind, randomized
controlled trial, in which Prophylactic
Mesh placementTechnique will be
compared with the conventionally used
large bites mass closure technique for the
closure of midline laparotomy.

36. Materials and Methods
• 100 consecutive patients reporting to the
department of General Surgery of BRK
Memorial Medical College in whom
midline laparotomy is indicated will be
included in this study.
• These 100 patients will be randomized into
two groups of 50 each.

37. Materials and Methods
• Group A patients will be managed by
conventional closure of the midline incision
• GroupB patients will be managed by Mesh
placement technique.
• One year after surgery the patients will be
examined for the complication of incisional
hernia clinically and sonographically.

38. Results: Outcome parameters
Primary outcome
• Primary outcome will be incisional hernia
occurrence within one year after surgery,
either clinically and/or ultrasonographically
detected.

39. Results: Outcome parameters
Secondary outcomes
• Postoperative complications
• Pain
• Quality of life
• Cost effectiveness

40. Conclusions:
• The trial will provide level 1b evidence to
support the preference for either a
Prophylactic Mesh placementTechnique
or for the conventionally used large bites
technique

41. Participants
• Participants: Patients undergoing midline
laparotomy in BRK Memorial Medical
College Jagdalpur will be included in this
study .

42. Inclusion criteria:
• Patients undergoing midline laparotomy in
BRK Memorial Medical College Jagdalpur .

43. Exclusion criteria
• None

44. Analysis
• Differences between randomized groups
will be tested with appropriate statistical
methods

45. Conclusion
• This trial is a comparative studyof
Conventional versus Prophylactic Mesh
placement technique of midline laparotomy
closure.

46. Bibliography
• Muysoms FE, Detry O, Vierendeels
T, Huyghe M, Miserez M, Ruppert
M, Tollens T, Defraigne JO, Berrevoet

47. MCQ
A research aims at
• (A) Verifying the existing knowledge
• (B) Acquiring new knowledge
• (C) Filling the missing links in the existing
Knowledge
• (D) All of the above

48. MCQ
A research aims at
• (A) Verifying the existing knowledge
• (B) Acquiring new knowledge
• (C) Filling the missing links in the existing
Knowledge
• (D) All of the above

49. MCQ
Reliability of a research result implies its
• (A) Verifiability
• (B) Validity
• (C) Uniqueness
• (D) Usefulness

50. MCQ
Reliability of a research result implies its
• (A) Verifiability
• (B) Validity
• (C) Uniqueness
• (D) Usefulness

51. MCQ
• In clinical research studies, conflict of
interest is a risk factor for scientific
misconduct.
– A.True
– B. False

52. MCQ
• In clinical research studies, conflict of
interest is a risk factor for scientific
misconduct.
– A.True
– B. False

53. MCQ
What is "blinding" and what is its purpose?
• A. Blinding means you begin with the null hypothesis, and
base your conclusions totally on a statistical analysis of the
data without any preconceived ideas.
• B. Blinding refers to equipoise, i.e. uncertainty regarding
whether a new treatment is effective.
• C. Blinding means that the subjects and/or investigators do
not know which treatment group the subject is in. The
purpose is to prevent bias in assessing the outcome.
• D. Blinding occurs when the results totally disagree with
previously published studies. Its purpose is to cause a re-
evaluation of the data.

54. MCQ
What is "blinding" and what is its purpose?
• A. Blinding means you begin with the null hypothesis, and
base your conclusions totally on a statistical analysis of the
data without any preconceived ideas.
• B. Blinding refers to equipoise, i.e. uncertainty regarding
whether a new treatment is effective.
• C. Blinding means that the subjects and/or
investigators do not know which treatment group the
subject is in. The purpose is to prevent bias in assessing
the outcome.
• D. Blinding occurs when the results totally disagree with
previously published studies. Its purpose is to cause a re-
evaluation of the data.

55. MCQ
Which statement about blinding in an
intervention study is NOT correct?
A. The purpose of blinding is to reduce bias in
determining the outcome.
B. The purpose of blinding is to reduce
confounding.
C. In a double blinded study, neither the subject nor
the investigators know which treatment the
subject is receiving.
D. Blinding can be accomplished by using a
placebo.

56. MCQ
Which statement about blinding in an
intervention study is NOT correct?
A. The purpose of blinding is to reduce bias in
determining the outcome.
B. The purpose of blinding is to reduce
confounding.
C. In a double blinded study, neither the subject nor
the investigators know which treatment the
subject is receiving.
D. Blinding can be accomplished by using a
placebo.

57. MCQ
• What are the documents mandatory to
enroll a subject in a clinical research
study?
– A. Protocol
– B. Case Report Form
– C. Informed Consent Form
– D. Investigator's Brochure

58. MCQ
• What are the documents mandatory to
enroll a subject in a clinical research
study?
– A. Protocol
– B. Case Report Form
– C. Informed Consent Form
– D. Investigator's Brochure

59. • Lectures one drive

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