Sunteți pe pagina 1din 29

A THESIS PROTOCOL

FOR M.S. DEGREE


(GENERAL SURGERY)

TOPIC : A CLINICAL STUDY ON BLUNT TRAUMA ABDOMEN


FOLLOWING ROAD TRAFFIC ACCIDENTS WITH
SPECIAL REFERENCE TO ITS MANAGEMENT.

NAME OF CANDIDATE : DR. MELVIN JOHN


POST–GRADUATE STUDENT
DEPARTMENT OF GENERAL SURGERY,
ASSAM MEDICAL COLLEGE & HOSPITAL,
DIBRUGARH.

NAME OF GUIDE :DR. ROCKET CHANDRA BRAHMA


ASSOCIATE PROFESSOR
DEPARTMENT OF GENERAL SURGERY,
ASSAM MEDICAL COLLEGE & HOSPITAL,
DIBRUGARH

PLACE OF STUDY : ASSAM MEDICAL COLLEGE & HOSPITAL,


DIBRUGARH.

DURATION OF STUDY : ONE YEAR

UNIVERSITY : SRIMANTA SANKARADEVA UNIVERSITY


OF HEALTH SCIENCES, GUWAHATI, ASSAM

SIGNATURE OF SIGNATURE OF SIGNATURE OF SIGNATURE OF


CANDIDATE THE GUIDE HEAD OF THE THE PRINCIPAL
DEPARTMENT
1. INTRODUCTION
Trauma is globall y the leading cause of death among people under age of
45years. 1
The Airway, Breathing, Circulation, Disabilit y, Exposure (ABCDE) approach is
applicable in all clinical emergencies for immediate assessment and treatment.
The approach is widel y accepted by experts in emergency medicine and likel y
improves outcomes by helping health care professionals focusing on the most
life-threatening clinical problems. To summarize the approach in simple terms: -
Airway - assessment of voice and breath sounds.
Breathing - assessment of respiratory rate, chest wall movements, chest
percussions and pulse oximetry.
Circulation - assessment of skin colour, sweating capillary refill time(<2s)
palpate pulse rate(60 -100 per min) heart auscultation blood pressur e and ecg
monitoring.
Disabilit y- assessment by evaluating level of consciousness, limb movements,
pupillary light reflexes and blood glucose level.
Exposure - assessment of expsed skin temperature.
Apart from this basic approach in management of any trauma, blunt abdominal
injury requires clinical examination to look for symptoms such as pain,
tenderness, rigidit y and bruising in the external abdomen. [ 1 6 ]

Liver and spleen are the two most common organs that are injured following
blunt abdominal trauma. 2
Motor vehicle collisions are a common source of blunt abdominal trauma. [ 3 ] Seat
belts reduce the incidence of injuries such as head injury and chest injury, but
present a threat to such abdominal organs as the pancreas and the intestines,
which may be displaced or compressed against the spinal column. [ 3 ]
Solid abdominal organs, such as the liver and spleen, bleed pro fusel y when cut
or torn, as do major blood vessels such as the aorta and vena cava. Hollow
organs such as the stomach, while not as likel y to result in shock from profuse
bleeding, present a serious risk of infection, especiall y if such an injury is not
treated promptl y. [ 3 ] Gastrointestinal organs such as the bowel can spill their
contents into the abdominal cavit y. Hemorrhage and systemic infectio n are the
main causes of deaths that result from abdominal trauma. [ 3 ]
The treatment method employed depends on t ype of injury, haemodynamic
stabilit y of the p atient, associated injuries, anaesthetic technique, laboratory
back-up and the experience of the surgeon. 4 - 5
Assessment of hemodynamic stabilit y is the most important initial concern in
the evaluation of a patient with blunt abdominal trauma. In the
hemodynamicall y unstable patient, a rapid evaluation for haemoperitoneum can
be accomplished by means of diagnostic peritoneal lavage (DPL) or the focused
assessment with sonography for trauma (FAST). Radiographic studies of the
abdomen are indicated in stable p atients when the physical examination findings
are inconclusive.
FAST
Bedside ultrasonography is a rapid, portable, noninvasive, and accurate
examination that can be performed by emergency clinicians and trauma surgeons
to detect haemoperitoneum.
The current FAST examination protocol consists of 4 acoustic windows
(pericardiac, perihepatic, perisplenic, pelvic) with the patient supine.
An examination is interpreted as positive if free fluid is found in any of the 4
acoustic windows, negative if no flui d is seen, and indeterminate if any of the
windows cannot be adequatel y assessed.
Diagnostic peritoneal lavage
DPL as a investigative procedure has limited scope in the setting of this study.
However, DPL is indicated for the following patients in the sett ing of blunt
trauma:
 Patients with a spinal cord injury
 Those with multiple injuries and unexplained shock
 Obtunded patients with a possible abdominal injury
 Intoxicated patients in whom abdominal injury is suggested
 Patients with potential intra -abdominal injury who will undergo prolonged
anesthesia for another procedure .
Computed tomography
Computed tomography is the standard for detecting solid organ injuries. CT
scans provide excellent imaging of the pancreas, duodenum, and genitourinary
s ystem.
CT scanning often provides the most detailed images of traumatic pathology and
may assist in determination of operative intervention. Unlike DPL or FAST, CT
can determine the source of haemorrhage.
Treatment of blunt abdominal trauma begins at the scene of th e injury and is
continued upon the patient’s arrival at the emergency department or trauma
center. Management may involve nonoperative measures or surgical treatment,
as appropriate.
Indications for laparotom y in a patient with blunt abdominal injury inclu de the
following ( 9 )
 Signs of peritonitis
 Uncontrolled shock or hemorrhage
 Clinical deterioration during observation
 Haemoperitoneum findings on FAST or DPL
When laparotomy is indicated, broad-spectrum antibiotics are given. A midline incision is
usually preferred. When the abdomen is opened, hemorrhage control is accomplished by
removing blood and clots, packing all 4 quadrants, and clamping vascular structures. Obvious
hollow viscus injuries (HVIs) are sutured. After intra-abdominal injuries have been repaired and
hemorrhage has been controlled by packing, a thorough exploration of the abdomen is then
performed to evaluate the entire contents of the abdomen.
After intraperitoneal injuries are controlled, the retroperitoneum and pelvis must be inspected.
Do not explore pelvic hematomas. Use external fixation of pelvic fractures to reduce or stop
blood loss in this region. Explore large or expanding midline retroperitoneal hematomas, with
the anticipation of damage to the large vascular structures, pancreas, or duodenum. Do not
explore small or stable perinephric hematomas.
After the source of bleeding has been stopped, further stabilizing the patient with fluid
resuscitation and appropriate warming is important. After such measures are complete, perform a
thorough exploratory laparotomy with appropriate repair of all injured structures.
A study by Crookes et al suggests that the true morbidity of a negative laparotomy may not be as
high as previously believed. They conclude that in blunt abdominal trauma patients, exploratory
laparotomy to establish a diagnosis does not result in increased morbidity in a 30-day period,
compared with no laparotomy. In other words, it is safer to undergo laparotomy with negative
findings than to delay treatment of an injury.

Nonoperative management
In blunt abdominal trauma, including severe solid organ injuries, selective
nonoperative management has become the standard of care. Nonoperative
management strategies are based on CT scan diagnosis and the hemodynamic
stabilit y of the patient, as follows: ( 1 5 )
For the most part, pediatric patients can be resuscitated and treated
nonoperativel y; some pediatric surgeons often transfuse up to 40 mL/kg of blood
products in an effort to stabilize a pediatric patient ( 1 3 )
Hemodynamicall y stable adults with solid organ injuries, primaril y those to the
liver and spleen, may be candidates for nonoperative management
Splenic artery embolotherapy, although not standard of care, may be used for
adult blunt splenic injury
Nonoperative management involves closel y monitoring vital signs and
frequentl y repeating the physical examination.
The present study will be undertaken to evaluate the various presentaions of
blunt abdomen trauma and its management, keeping in mind the recent trend of
managing patients, both with nonoperative as well as operative methods and
common complications.
AIMS
1. Tostudy the patients presenting with blunt abdominal trauma following road traffic accident
and evaluate management of these patients.
Objectives
1. To study various investigations for detection of blunt abdominal trauma

2. To study the various modalities of treatment, whether operative or non-operative.

3. To study the effect of the above on morbidity and mortality of these patients in the tenure of
hospital stay.
REVIEW OF LITERATURE:

Blunt injury as causes of intra-abdominal injuries have been recognized since


historical times. Aristotle was the first to record visceral injuries from blunt trauma. Hippocrates
and Galen are said to have given apt description of the condition.6

By 1500 BC distinct triage and surgical protocol had been developed in Babylonia
under the rule of Hammurabi as said by Edwin Smith Papyrus.

In 1903,Senn described nonoperative management of splenic injury.7

In 1906 Solomen performed Peritoneal lavage for the first time. 8

In 1934 Aenhium used puncture of abdominal wall as a diagnostic procedure in


abdominal injuries.9

Operative mortality rates remained high until the 1950s, when new and rapid
advancements in surgical and anesthesia sciences occurred. Non operative care during this period
was predominantly fatal. Prior to the advent of CT scanning, physical examination and
diagnostic procedures such as diagnostic peritoneal lavage (DPL) and were the only diagnostic
methods. Minor injury was probably frequently missed, while major injury prompting
laparotomy for hypotension or physical findings was the normal.

The development of emergency medical service is an important milestone in the


history of clinical and surgical practice of trauma. Greeks required physicians to be present
during the battle and Romans established the hospitals close to the battlefield.6

Salomone Di Saverio et al10 (2012) suggested that at the beginning of the 21st
century, when NOM for liver and spleen injuries is often advocated beyond the limits of a
reasonable safety and the need for surgery is considered as a defeat or "failure". We should not
forget in making the best treatment choice, to keep in mind not only the predictors of NOM
failure, such as the injury grade, the presence of associated intra-abdominal injuries and the risk
of missing injuries with the subsequent sequelae, of a failed NOM and of delayed surgical
treatment, but we must also consider the potential drawbacks of angioembolization, the
environmental setting and factors, i.e. the level of the hospital (trauma center), availability of
Angio Suite and ICU for continuous monitoring, the initiation of NOM during night shift, the
need of an eventual time consuming spine surgery in a prone position for a concomitant vertebral
fracture, and last but not least, the time needed for complete and safe resumption of normal life
(work and physical activity).

In a 3 year study conducted by Ting-Min Hsieh et al (2011)11 150 patients


presented with high-grade BHSI(blunt hepatic and splenic injury), of whom 91 and 59 had
BHI(blunt hepatic injury) and BSI(blunt splenic injury), respectively. The majority of the study
subjects were men (62%), with a mean age of 31.9 ± 16.3 years (range, 3–77). The most
common causes of high-grade BHI were motorcycle collision (n = 55, 60.4%), motor vehicle
collision (n = 18, 19.8%), falls from greater height (n = 7, 7.7%) or from own height (n = 4,
4.4%), pedestrian struck (n = 3, 3.3%), assaults (n = 2, 2.2%), and bicycle collision (n = 2,
2.2%).

In another study conducted by John L. Kendall et al (2011)12 during a 2-year


study period, 7,369 patients were admitted to the observation unit. Of these, 1,277 (17%) were
observed specifically for BAT. The median age of the study sample was 31 (IQR: 23–42) years,
and 715 (66%) were male. The most common mechanisms resulting in BAT were motor vehicle
collision (73%).

MATERIALSANDMETHODS:

PLACE OF STUDY : The study will be conducted in the Department of General Surgery,
Assam Medical College & Hospital, Dibrugarh
DURATION OF STUDY : One year
TYPE OF STUDY : Hospital Based Prospective Study
SAMPLE SIZE : All patients admitted in the General surgical units of Assam
Medical College & Hospital, Dibrugarh with Haemoperitoneum during the study period and
fulfilling the inclusion and exclusion criteria.
STUDY POPULATION :Patients with blunt abdominal trauma admitted in Assam Medical
College & Hospital, Dibrugarh

METHODS OF COLLECTION OF DATA:

After admission data for study will be collected by:


(1) Direct interview with the patient or patient relatives accompanying the patient and
obtaining a detailed history.
(2) From hospital records for operative or non operative management that the patient may
have undergone.
(3) Thorough clinical examination.
(4) Clinical findings and relevant diagnostic investigations performed on the patient.
After initial resuscitation of the patients, thorough assessments for injuries will be carried out in
all the patients. Documentation of all relevant data, which will include identification, history,
clinical findings, diagnostic test, operative findings, operative procedures, complications during
the stay in the hospital and during subsequent follow-up period, will be recorded on a Proforma
specially prepared. Demographic data to be collected will include the age, sex, occupation of the
patient and nature and time of accident leading to the injury. Additional injuries other than these
will also be considered. Pain, respiratory distress and additional injuries will be treated as
approprioate.After initial radiologic investigation and diagnostic peritoneal lavage ,operative
decision will be taken depending on haemodynamic stability of the patients.
Follow up programme: After discharge ,patients are called for follow up at 1 week and 1
month. Assessment of late complication and appropriate treatment will be undertaken.

INCLUSION CRITERIA:
 All patients diagnosed with blunt abdominal trauma admitted in different General
Surgical Units of AMCH, during the study period.

Exclusion Criteria:
 All Patients with blunt trauma abdomen admitted in Paediatrics surgery Ward of AMCH
will be excluded.
 All patient with penetrating injuries admitted in AMCH will be excluded.
 Patients who refused to give consent to take part in the study.
 Patient who left during follow-up period(1month)
 Patients with blunt abdomen trauma following any other modes of injury like physical
assault or fall from a height.

Statistical Analysis:

Data will be statistically described in terms of range,mean ± standard deviation (±SD),


frequencies (number ofcases) and relative frequencies (percentages) when appropriate.All
statistical calculations will be done using proper statistical methods.
RESULTSANDOBSERVATIONS

The results and observation will be expressed in appropriate tables and graphs at the end of
the study, as detailed below. More tables will be added if required.

TABLE1: AGE DISTRIBUTION

AGE NUMBE PERCEN


GROUP R TAGE
(in years) (n) (%)

12—19

20—29

30—39

40—49

50—59

60—69

70—79

TOTAL
TABLE 2: SEX DISTRIBUTION

NUMBE PERCEN RATIO


SEX R TAGE (Male :
(n) (%) Female)

Male

Female

TOTAL

TABLE 3: INHABITANCE

NUMBER PERCENTAGE
Inhabitance
(n) (%)

Urban

Rural

TABLE 4: MODE OF INJURY

NUMBE PERCEN
MODE OF INJURY R TAGE
(n) (%)

Blunt RTA
Trauma Assaults

Fall fromHeights

TABLE 5: GENERAL CONDITION

GENER
NUMBE PERCEN
AL
R TAGE
CONDIT
(n) (%)
ION

Stable

Unstable

TOTAL
TABLE 6: SYMPTOMS

PERCENT
NUMBER
SYMPTOMS AGE
(n)
(%)

Abdominal Pain

Abdominal Distension

Vomitting

Hematuria

Symptoms of Shock

Tenderness in the lower


chest

Others

TABLE 7:SIGN/CLINICAL FEATURE

NUMBER PERCENTAGE
SIGN (n) (%)

Guarding and Rigidity

Abdominal Tenderness

Distension

Sign of Shock

Shifting Dullness

Others
TABLE 8A: TIME INTERVAL BETWEEN TRAUMA AND ARRIVAL AT CASUALTY

TIME NUMBE PERCEN


(in R TAGE
hours) (n) (%)

0–12 hrs

12-24 hrs

24-36 hrs

36-48 hrs

Beyond
48 hrs

TOTAL

TABLE 8B: TIME INTERVAL BETWEEN TRAUMA AND SURGERY

TIME NUMBE PERCEN


(in R TAGE
hours) (n) (%)

0–12 hrs

12-24 hrs

24-36 hrs

36-48 hrs

Beyond
48 hrs

TOTAL
TABLE 9: ULTRASOUND EXAMINATION

HAEMOPERITON
HAEMOPERITONE
EUM
UM ABSENT
PRESENT

Test
Positive

Test
Negative

TOTAL

TABLE 10: CAUSE OF INJURY (CECT )

NUMBE PERCEN
R TAGE
(n) (%)

SPLEEN

LIVER

BOWEL

MESEN
TRY

OTHERS

TOTAL
TABLE 11: MANAGEMENT

NUMBE PERCEN
OPTIONS R TAGE
(n) (%)

Operative

Conservative

TOTAL

TABLE 12: HOSPITAL STAY

HOSPITAL NUMBER PERCENTAGE


STAY IN DAYS (n) (%)

0-5

6-10

11-15

16-20

21-25

More than 25
TABLE 13:COMPLICATIONS

NUMBE PERCEN
COMPLICATIONS R TAGE
(n) (%)

Wound Infection

Wound dehiscence

Intra Abdominal
Collection

Sepsis

Respiratory
complication

Others

TABLE 14:MORTALITY

NUMBER PERCENTAGE
TYPE OF TREATMENT
(n) (%)

Operative

Conservative

Total
DISCUSSION:

The results and observations made in the study w will be discussed in details with
relevant study on the subject by other authors and critically analysed.

SUMMARY AND CONCLUSION:

Finally the results of this study will be summarized and a conclusion will be
derived from the critical analysis of the observations made during the study.
BIBLIOGRAPHY:

(1) Sauaia A. Moore FA, Moore EE, Moser KS, Brennan R, Read RE et al. Epidemiology of
Trauma death a reassessment J trauma 1995;38(2):185-193.

(2) Visrutaratna P, Na-Chiangmai W; Computed tomography of blunt abdominal trauma in


children. Singapore Med J ., 2008;49 (4): 352–358.

(3) Buccoliero ,F. and Ruscelli ,P. Splenic trauma. In the management of trauma.From the
territory to the Trauma Center. Edited by: Cenammo A. Napoli: Italian Society of
Surgery, 2010. p. 138 - 50.

(4) Demetriades D, Hadjizacharia P, Constantinou C, Brown C, Inaba K, Rhee P, Salim A.


Selective nonoperative management of penetrating abdominal solid organ injuries. Ann
Surg 2006;244(4): 620-628.

(5) Harbrecht BG. Is anything new in adult blunt splenic trauma? Am J Surg 2005;1 90(2):
273-278.

(6) Reihner E, Brismar B. Management of splenic trauma--changing concepts. Eur J Emerg


Med 1995;2(1): 47-51.

(7) Reigner O. Uebereinen Fall Extinpantion der traumatischzerrissenenMilz.


BerlKlinWochenschr 1893;30:177-182

(8) Senn N. the surgical treatment of traumatic Haemorrhage of spleen. JAMA 1903,
41:1241:-5.

(9) Maingot abdominal operation 11th edition p-772-184.

(10) J. David. Richardson, Martha. Brewer, Management of Upper abdominal solid organ
injuries, AORN Journal May, 1996.

(11) Di Saverio S, Moore EE, Tugnoli G, Naidoo N, Ansaloni L, Bonilauri S, Cucchi M,


Catena F. World J Emerg Surg. 2012 Jan 23;7(1)3.doi:10.1187/1749-7922-7-3.

(12) Hsieh T-M, Cheng Tsai T, Liang J-L, Che Lin C. Non-operative management attempted

(13) Mahajan P, Kuppermann N, Tunik M, Yen K, Atabaki SM, Lee LK, et al.
Comparison of Clinician Suspicion Versus a Clinical Prediction Rule in
Identifying Children at Risk for Intra -abdominal Injuries After Blunt
Torso Trauma. Acad Emerg Med . 2015 Sep. 22 (9):1034 -41.

(14) Holmes JF, Kelley KM, Wootton -Gorges SL, Utter GH, Abramson LP,
Rose JS, et al. Effect of Abdominal Ultrasound on Clinical Care,
Outcomes, and Resource Use Among Children With Blunt Torso Trauma:
A Randomized Clinical Trial. JAMA. 2017 Jun 13. 317 (22):2290 -2296.

(15) Mahajan P, Kuppermann N, Tunik M, Yen K, Atabaki SM, Lee LK, et al.
Comparison of Clinician Suspicion Versus a Clinical Prediction Rule in
Identifying Children at Risk for Intra -abdominal Injuries Afte r Blunt
Torso Trauma. AcadEmerg Med . 2015 Sep. 22 (9):1034 -41.

(16) T roe ls T him , N i e ls He nr ik V in t her Kr ar up , Er ik L erk ev a ng G r o ve , et a l. Initial


assessment and treatment wit h the Air way, Breat hing, Circulat ion,
Disabilit y, and Exposure (ABCDE) approach . In t J G e n Me d . 20 1 2; 5 : 1 1 7–
12 1 .
ANNEXURE-I

PROFORMA
Case No. : Hospital No.:
MRD No. :
Name : Age/Sex :
Address :
Religion : Occupation:
Rural/Urban :
Date of injury : Date of Admission:
Date of Operation:
Date of discharge :

Presenting Complaints:

Type of Injury : Time :

Place :
Mode of Injury :
 Road Traffic Accident
 Assault
 Fall
 Others
Events that followed :
History of Present Illness:
Pain Abdomen :
Vomiting :
Distension of Abdomen :
Shoulder tip pain :
Cold clammyextrimities :
Any Other Complaints :
Associated Injuries if any :
Previous History :
Personal History :

Examination:
General Physical Examination:
 Consciousness :
 Decubitus :
 Pulse :
 Blood pressure :
 Respiratory rate :
 Hydration :
 Pallor :
 Temperature :
 Others :

Per Abdomen Examination:


Inspection:
 Shape :
 Skin over abdomen :
 Visible injuries :
 Prominent swellings :
 Movement with respiration:
 External genitalia :

Palpation:
 Temperature :
 Tenderness :
 Guarding :
 Rigidity :
Percussion:
Auscultation:
 Bowel sounds :
Per rectal findings :
Associated injuries:
 Head and neck :
 Thorax: ribs :
 Hemopneumothorax :
 Spine :
 Pelvis :
 Extremities :

Systemic Examination:
Respiratory system :
Cardiovascular system :
Central nervous system :

Provisional Diagnosis:

Investigations:
Examination of Blood:
Blood : Haemoglobin (Hb%) :
Total Leukocyte Count (TLC) :
Differential Leukocyte Count (DLC) :
Platelet count :
ESR :
ABO Grouping & Rh Typing :
Blood sugar :
S. Creatinine :
Blood Urea :
Urine : Color:
Clarity: Albumin:
Sugar: Microscopy:
Serum: Amylase :
Bilirubin : Electrolytes:
Radiological Investigation:
USG Abdomen :
X ray:
 Erect Abdomen :
 Chest :
 Pelvis :
 Spine :
CT Scan of Brain/Abdomen :

Management:
 Conservative :
 Fluids given :

Type of Blood Blood


Day Amount
Fluids Transfusion Presure

1st Day

2nd Day

3rdDay

4thDay

5thDay

6thDay

7thDay
Operative:
If operative:
 Date of operation :
 Type of surgery :
 Anesthesia :

Operative Findings :

Final Diagnosis :

Follow up:

 1st Week :

 1 month
ANNEXURE-II

PATIEN T CONSENT FORM

TITLE OF THE STUDY: A CLINICAL STUDY O F BLUNT TRAUMA


ABDOMEN FOLLOWING ROAD TRAFFIC ACCIDENTS WITH SPECIAL
REFERENCE TO ITS MANAGEMENT.

Documentation of the Informed Consent:

I, … … … … … … … … … … … … … … … … have read the information in


this form (or it has been read to me). I was free to ask any questions and they
have been answered. I am over 18 years of age and, exercising m y free power of
choice, hereby give my consent to be included as a participant in “A CLINICAL
STUDY OF BLUNT TRAUMA ABDOMEN FOLLOWINGROAD TRAFFIC
ACCIDENTS WITH SPECIAL REFERENCE TO ITS MANAGEMENT.I have read
and understood this consent form and the information provided to me.

1. I have had the consent document explained to me.


2. I have been explained about the nature of the study.
3. My rights and responsibilities have been explained to me by the investigator.
4. I have been advised about the risks associated with my participation in the study.
5. I have informed the investigator of all the treatments I am taking or have taken .
6. I agree to cooperate with the investigator and I will inform him/her immediately if I suffer
unusual symptoms.
7. I have not participated in any research study within the past … … … …month(s).
8. I am aware of the fact that I can opt out of the study at any time without having to give any
reason and this will not affect my future treatment in the hospital.
9. I am also aware that the investigators may terminate my participation in the study at any
time, for any reason, without my consent.
10. I hereby give permission to the investigators to release the information obtained from me as
result of participation in this study to the sponsors, regulatory authorities, Government
agencies, and ethics committee. I understand that they may inspect my original records.
11. My identity will be kept confidential if my data are publicly presented.
12. If, despite following the instructions, I am physically harmed because of any substance or
any procedure as stipulated in the study plan, [my treatment will be carried out free at the
investigational site / the sponsor will bear all the expenses], if they are not covered by my
insurance agency or by a Government program or any third party.
13. I have had my questions answered to my satisfaction.
14. I have decided to be in the research study.
I am aware, that if I have any questions during this study, I should contact at
one of the addresses listed above. By signing this consent from, I attest that
the information given in this document and the HIV consent form has been
clearl y explained to me and apparent l y understood by me. I will be given a
copy of this consent document.
Name and signature / thumb impression of the participant (or legal
representative if participant incompetent):
… … … … … … … … … … … … … … … … (Name) … … … … … … … …
(Signature)
Date: … … … … … … Time: … … … … …
Name and signature of impartial witness (required for illiterate patients):
… … … … … … … … … … … … … … … … (Name) … … … … … … … …
(Signature)
Date: … … … … … … Time: … … … … …
Address and contact number of the impartial witness: ___________________
… … … … … … … … … … … … … … … … (Name) … … … … … … … …
(Signature)
Date: … … … … … … Time: … … … … …
Name and signature of the Principal/Co-investigator obtaining consent:
… … … … … … … … … … … … … … … … (Name) … … … … … … … …
(Signature)Date: … … … … … … Time: … … … …
ANNEXURE-III
To,
The Chairman,
Institutional Ethics Committee (H),
Assam Medical College,
Dibrugarh, Assam.

(Through proper channel)

Sub: Permission to undertake thesis work.


Respected Sir,
With due respect, I would humbl y like to request you to grant me
the permission to undertake thesis work and provide the Ethical Clearance
Certificate for the study titled “A CLINICAL STUDY ON BLUNT
TRAUMA ABDOMEN FOLLOWING ROAD TRAFFIC ACCIDENTS
WITH SPECIAL REFERENCE TO ITS MANAGEMENT” in the
Department of General Surgery, Assam Medical College for a period of
One year.

Thanking You.
Yours sincerel y,

(DR. MELVIN JOHN)


Postgraduate trainee,
Department of General Surgery,
Assam Medical College &Hospital
Dibrugarh.

S-ar putea să vă placă și