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Journal Reading

A COMPARATIVE STUDY BETWEEN


HAEMOCOAGULASE AND ADRENALINE
IN TYPE 1 TYMPANOPLASTY

Muhammad Reko Danuwirya, MD

Department of Otorhinolaryngology Head and Neck Surgery


Faculty Of Medicine Andalas University/Dr. M. Djamil
Hospital Padang - 2019
INTRODUCTION

Surgeon

Intraoperative bleeding

Pursuit for a bloodless field

Obscure surgical field result in poor visualization of


critical structure
INTRODUCTION

Middle ear
haemostasis

Adrenaline
Haemocoagulase
soaked cotton VS Topical solution
balls

Gold Standart
INTRODUCTION

Enzyme complex
Isolated from snake poison

Coagulative and
antihaemorhagic properties
Haemocoagulase
Accelerating the conversion
fibrinogen to fibrin polymer

Promote interaction of platelets


with fibrin clot
INTRODUCTION

Haemocoagulase for
treatment of sudden
SNHL

Previous No reports Novel study


study haemocoagulase comparing
being used for adrenaline and
achieving haemocoagulase
haemostasis in for attaining
middle ear surgery haemostasis
MATERIALS AND METHODS

Prospective double Tertiary care hospital in


January 2013 to June
blinded comparative Mangalore, Southern
2014
study India
MATERIALS AND METHODS

• 15-50 range of age


• Undergoing type I tympanoplasty with
or without cortical mastoidectomy
• Normotensive
• Normal coagulation profile
MATERIALS AND METHODS

Exclusion
• Aditus block
• Clotting disorders and systemic ilness
• Blood pressure > 150/99 mmHg
MATERIALS AND METHODS

A B
(50 cases) (50 cases)
• 2 ml • 2 ml Adrenaline
haemocoagulase • 1 : 1000 dilution
• 0.2 Coagulation of adrenaline
unit per ml
MATERIALS AND METHODS

Underwent
Tympanoplasty Time duration cortical
mastoidectomy
• Post aural • From placing • Mastoidectomy
approach the canal was perform
incision till initially
replacement of • Tympanoplasty
tympanomeatal was perform
flap after the later
placement of
graft
MATERIALS AND METHODS

During the procedure

• Mean blood pressure


• Number of cotton balls required
• Surgeon comfort levels score
• Post operative hearing level assessed
after 3 months and compare with pre
operative

Note
MATERIALS AND METHODS

Score 0
(Poor response)

Score 1
(Average response)
Surgeon comfort
levels
Score 2
(Good response)

Score 3
(Excellent response)
MATERIALS AND METHODS

Statystical analysis

IBM SPSS statistics

t-Test, Chi Square Test

p value < 0.05 (significance level)


RESULTS

Procedures
100
84 80
80
60
40
16 20
20
0
Group A Group B
Timpanopalsty With Cortical TM
RESULTS

Group A Group B
• Congested • Congested
Middle middle ear middle ear
ear mucosa (16 mucosa (22
mucosa cases) cases)
• Normal middle • Normal middle
ear mucosa (34 ear mucosa (28
cases) cases)
RESULTS

Group Cases Mean SD t DoF P value


A 50 4 1.877 2.727 83.455 0.008
B 50 3 1.204

The average number of cotton balls used in group A was 4


and in group B was 3, with p < 0.008
P value was <0.001

RESULTS

Time taken Mean BP


48 100 90
46 74
46
44 50
44
42 0
Group A Group B Group A Group B
Time taken Mean BP

Operation time
100 65 50
0
Group A Group B
Operation time
RESULTS

Surgeon comfort level


6
Group A 26
13
5
14
Group B 28
8
0

0 10 20 30
Score 3 Score 2 Score 1 Score 0

A significant p value of 0.005  more comfortable with


adrenaline >< haemocoagulase
RESULTS

Post Operatif Hearing Level


12.5
12.12
12
11.64
11.5

11
Hearing level
Group A Grup B
RESULTS

Graft Uptake
101
100
99 6 2
98
97 98
96
95
94
93 94
Failure
92 Success
91
Group A Group B

The p value was 0.307


DISCUSSION

Long standing infection of


the middle ear

Characterized by ear Bleeding is a major


Chronic discharge and permanent drawback in all ear
otitis changes in TM surgeries
media
(Gopen, Treated by ear toileting, A bloodless field
2010) topical and systemic AB and reduces the risk of
surgical intraoperative
complications
Eradicate the disease and to
close the perforation
DISCUSSION

Adrenaline Fibrin based


haemostats
Bone wax Hydrogen
Middle ear surgery peroxyde
Gelatin based
haemostats Cautery

Collagen based
Haemostasis haemostats

(Acar et al 2010;
Anschuetz et al
2017)
DISCUSSION

Sympathomimetic
hormone and a
neurotransmitter

Adrenaline With both alpha and beta


(Joshi et al 2014) adrenergic receptors

Vasoconstriction of
arterioles in mucosa 
alpha receptor
predominant stimulation
DISCUSSION

Enzyme complex  South American


snake species “Bothrops Jarararca” and
“Bothrops Atrax”

Arresting the capillary bleeding and


promoting wound healing
Haemocoagulase
(Joshi et al 2014)
Reduces blood cloting time significantly

Devoid antigenic capacity and does not


cause appearance of immunologic
phenomenon
DISCUSSION

Haemocoagulase

Surgical procedures

Cosmetic
Adeno- Treating
Dental surgeries, to Bleeding
tonsillectomy, sudden
extraction prevent disorders
ophthalmic deafness
(Gupta et al pulmonary (Wang et al
surgeries (Lee (Thelwell et
2018) haemorrhage 2012)
et al 1989) al 2016)
(Shi et al, 2005)
DISCUSSION

In this study

Adrenaline was better at achieving haemostasis

Intraoperative rise in blood pressure was more in adrenaline

The mean number of cotton balls used in haemocoagulase


group more than adrenaline group

The duration of surgery was more in haemocoagulase group


DISCUSSION

In this study (2)

Post operative hearing improvement was similar in both groups


with improvement of 11-12 dB

There was no significant difference in post operative graft


uptake : 98% (adrenaline) and 94% (haemocoagulase)

The cost of haemocoagulase is double that of adrenaline


DISCUSSION

• A significant difference in bleeding


stoppage time, postoperative pain, and
swelling between hemocoagulase and
Majumder control (no drug)
et al (2014) • The use of hemocoagulase solution
after extractions, provides faster
haemostasis, enhances healing by
rapid formation of healthy tissue
DISCUSSION

Conrado et al (2007)
• Cardiovascular effects of local anaesthesia with
epinephrine in periodontal treatment revealed an increase
in systolic and diastolic BP

Aarnivaara L et al (1977)
• Use of adrenaline for middle ear haemostasis was found to
increase blood pressure both under general and local
anaesthesia
DISCUSSION

In this study
• Middle ear in patients with hypertensive diseases.
• The mean blood pressure was significantly less in
haemocoagulase group

Kwakami et al (1992), Thelwell et al (2016)


• Haemocoagulase  the blood flow in the inner ear
used in sudden sensory neural hearing loss
DISCUSSION

In this study
• A mean improvement of 11.64 dB in haemocoagulase
group and a mean improvement of 12.12 dB in adrenaline
group
• Indicates that both adrenaline and haemocoagulase can
be used safely in middle ear haemostasis
LIMITATION

Subjective assessment of congestion and


edematous middle ear mucosa

Relatively small sample

There were no other confounding factors


CONCLUSION

ʛ Achieving middle ear haemostasis is vital to the


outcome of tympanoplasty
ʛ Adrenaline was a better haemostatic agent than
haemocoagulase
ʛ Haemocoagulase maybe the preferred agent in
hypertensives
P.I.C.O

Problems/ Patients Intervention


Patients undergoing type I Haemocoagulase soak cotton
tympanoplasty with or without balls
cortical mastoidectomy

P.I.C.O
Comparison Outcome
Adrenalin soak cotton balls Average number of cotton balls
use, Mean BP, Time duration,
Hearing level improvement,
Graft uptake
CRITICAL APPRAISAL

A. ARE THE STUDY RESULT VALID ? Yes No Can’t


tell
1 Was the assignment of patients to V
treatment groups truly randomized ?

2 Were all patients who entered the study V


accounted for appropriately at the end

3 Were patients, physicians, and those doing V


the assessments "blind" to treatment?
4 Was similarity between groups V
documented?
5 Aside from the intervention, were the V
groups treated in the same way
CRITICAL APPRAISAL

B. WHAT WERE THE RESULTS?


1 How large was the treatment effect ?

Could not be calculated

2 How precise was the estimate of the treatment effect?

Average number of cotton balls use p 0.008, the mean


blood pressure p < 0.001, time duration p < 0.001,
surgeon comfort level p 0,005
CRITICAL APPRAISAL

C. ARE THE STUDY RESULT VALID ? Yes No Can’t


tell
1. Can the results be applied to my V
patient (care)?

2. Were all clinically important outcomes V


reported?
3. Are the likely treatment benefits V
greater than the potential harms and
costs?
Thank You
Juli 2018 dr. M. Reko Danuwirya

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