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SYNOPSIS
GUIDE
DR. MEGHA JAIN
HEAD OF DEPARTMENT
DEPARTMENT OF RADIODIAGNOSIS
Submitted by:
Dr. AKARSH TANEJA
DEPARTMENT OF RADIODIAGNOSIS
SYNOPSIS
PRINCIPLE INVESTIGATOR
DR AKARSH TANEJA
POST GRADUATE STUDENT
Department of Radiodiagnosis
L.N. Medical College and Research Centre
GUIDE
DR MEGHA JAIN
HEAD OF DEPARTMENT
DEPARTMENT OF RADIODIAGNOSIS
The Chairman
I am here with enclosing the detail of project work. I submit the following undertaking: -
•I will start the study after obtaining approval of the Institutional ethics committee (IEC)
•I will get informed consent from the patients and maintained confidentiality of the
details and essentially obtain an informed consent from the family in case of post
mortems studies.
•I will carry out the work without detrimental to regular activities as well as without
extra expenditure to the Institution or the Government.
•I will inform the committee in the occurrence of any change in the study procedure,
site, investigation or guide.
•I will not deviate from the area of work for which I have applied for ethical clearance.
•I will inform the Institution ethics committee immediately in the occurrence of any
adverse events or serious adverse reactions.
•I will submit the summary / report of the study / project to the institution ethics
committee (IEC) on completion.
•I will not claim funds from the institution while doing the work or on completion.
•I understand that the members of the institutional ethics committee (IEC) have the right
to monitor the study / project without prior intimation.
Thanking You
Date:
Yours obediently
Place:
The dissertation titled As I have proposed to conduct “ Role of computed tomography in non
traumatic acute abdomen in adults.” An observational Study”.
-
”By Dr. AKARSH TANEJA at L.N. Medical College & J. K. Hospital, Kolar Road,
Bhopal
will be done according to the regulations of the institutional ethics committee and I
recommend it for acceptance.
Date:
HOD
DEPARTMENT OF RADIODIAGNOSIS
L.N. MEDICALCOLLEGE,
BHOPAL
NO OBJECTION CERTIFICATE FROM THE HOD
The dissertation/study titled To Study “Role of computed tomography in non traumatic acute
abdomen in adults.” -
By Dr. Akarsh Taneja at L.N. Medical College & J. K. Hospital, Kolar Road, Bhopal will be done
according to the regulations of the Institutional Ethics Comittee. I have no objection on study and
recommend it for acceptance.
Date…………………….
HOD
Department of Radio diagnosis
L. N. Medical College,
Bhopal
REMARKS OF THE GUIDE
Medical College & J. K. Hospital, Kolar Road Bhopal (MP) will be under my
supervision and I ensure that the candidate will abide by the rules of the
institutional ethics committee.
Date:
DR MEGHA JAIN
HEAD OF DEPARTMENT
DEPARTMENT OF RADIODIAGNOSIS
L.N.MEDICAL COLLEGE , BHOPAL
RECOMMENDATION OF THE DEAN
The dissertation / study titled “Role of computed tomography in non traumatic acute abdomen in
adults.” - An observational Study” by Dr. Akarsh Taneja at L.N. MEDICAL COLLEGE
-
Date:
The statistical analysis of work undertaken by Dr. AKARSH TANEJAtopic “Role of computed
tomography in non traumatic acute abdomen in adults.” at L.N. medical college, Bhopal will be done
-
Name:
Designation:
Department: Community
Bhopal
UNDERTAKING BY THE INVESTIGATOR
1 Investigator name: DR. AKARSH TANEJA , Room no : S10 PG1, J. K. Hospital campus, Kolar
road, Bhopal Title : PG 1ST YEAR GENERAL RADIODIAGNOSIS
Protocol title: “Role of computed tomography in non traumatic acute abdomen in adults.” -
5.Commitments
I have reviewed the clinical protocol and agree that it contains all the
necessary information to conduct the study. I will not begin the study until all
necessary ethics committee and regulatory approvals have been obtained.
i. I agree to conduct the study in accordance with the current protocol. I will not
implement any deviation from or changes of the protocol without agreement by
the sponsors and prior review and documented approval or favorable opinion
eliminate and immediate hazard to the trial subjects or when the changes
involved are only logistical or administrative in nature.
ii. Agree to personally conduct and /or supervise the clinical trial at my site
iii. I agree to inform all subjects on, that the drugs used for investigational purpose
and I will ensure that the requirement related to obtaining the informed
consent and ethics committee review and approval specified in GCP guidelines
are met.
iv. I agree to report the sponsor on adverse experience that occurs in the course
of investigation in accordance with the regulatory and GCP guidelines.
v. I have read and understood the information in the investigator’s brochure,
including the potential risk and side effect of drug.
vi. I agree to ensure that all associates, collogues and employees assisting the
conduct of the study are suitably qualified and experienced and they have been
informed about their obligations in meeting their commitments in the trial.
vii. I agree to maintain adequate and accurate records and to make those records
available for audit/ inspection by the sponsor, ethics committee, licensing
authority or their authorized representatives, in accordance with the regulatory
and GCP provisions. I will fully cooperate with any study related audit
conducted by regulatory officials or authorized representative of the sponsor.
viii. I agree to promptly report to the ethics committee for changes in clinical trials
activities and all anticipated problems involving risk to human subjects or others.
ix. I agree to inform all unexpected serious adverse events to the sponsors as well as
ethics committee within 7 days of their occurrence.
x. I will maintain confidentiality of the identification of all participating study
patients and assure security and confidentiality of study data.
xi. I agree to comply with all requirements, guidelines and statutory obligations as
applicable to clinical investigator participating in clinical trials.
Signature of investigator
Date:………………
1.
TITLE OF THESIS Role of computed tomography in non traumatic acute abdomen in adults .
2.
AIM:- To determine the contributions of CT in non-traumatic acute abdomen for
AIMS AND confirmation of diagnosed or equivocal USG cases, its management and
OBJECTIVES postoperative follow-up .
OR
To study, assess, and diagnose causes of acute abdomen accurately so as to
minimize the chances of exploratory laparotomy and unnecessary operations and
consequently improved patient care .
The use of conventional radiography (X-rays) has been nowadays of little value with
significance being in the setting of bowel obstruction showing dilated bowel loops
with air fluid levels.
12. DOES THE STUDY The study is mainly based on Radiology imaging being a
REQUIRE ANY tool of Investigation. The study involves
INVESTIGATIONS OR
only humans. Informed consent would be taken from the
INTERVENTIONS TO BE
CONDUCTED ON patient after explaining about and before
PATIENTS OR OTHER CT Imaging .
ANIMALS? IF SO
PLEASE DESCRIBE
BRIEFLY.
Name of patient :
Age/ Sex :
Residential address:
Contact no:
Date of Admission :
OPD/IPD no:
Consultant Incharge
CHIEF COMPLAINTS
HISTORY OF PRESENT
ILLNESS
PAST HISTORY
PERSONAL HISTORY
OBSTETRIC
HISTORY/MENSTRUAL
HISTORY
CLINICAL PROFORMA :-
CBC Hemoglobin-
TLC-
DLC-
PLATELET-
LFT Total bilirubin- SGOT-
SGPT-
Direct bilirubin- ALP-
Indirect bilirubin- Albumin-
S.ELECTROLYTE Na+ -
K+ -
HbA1C
appendicolith
periappendiceal reactive nodal enlargement
Acute cholecystits :
cholelithiasis: gallstones isodense to bile will be missed on CT
gallbladder distension
gallbladder wall thickening
mural or mucosal hyperenhancement
pericholecystic fluid and inflammatory fat stranding
high-density bile
enhancement of the adjacent liver parenchyma due to reactive
hyperemia
tensile gallbladder fundus sign
o fundus bulging the anterior abdominal wall
o ~75% sensitivity and ~95% specificity for acute cholecystitis in the
absence of any other CT features
o useful sign in making an early diagnosis
Acute pancreatitis :
o Focal or diffuse parenchymal enlargement
o changes in density because of edema
o indistinct pancreatic margins owing to inflammation
o surrounding retroperitoneal fat stranding
liquefactive necrosis of pancreatic parenchyma
o lack of parenchymal enhancement (should ideally be 1 week after
symptom onset to differentiate from pancreatic hypoenhancement
secondary only to edema)
o often multifocal
infected necrosis
o difficult to distinguish from aseptic liquefactive necrosis
o the presence of gas is helpful (emphysematous pancreatitis)
o FNA helpful
abscess formation
o circumscribed fluid collection
o little or no necrotic tissues (thus distinguishing it from infected
necrosis)
hemorrhage
o high-attenuation fluid in the retroperitoneum or peripancreatic
tissues
calcification
o evidence of background chronic pancreatitis
retroperitoneal fat necrosis 33
o low density collection showing minimal heterogeneity
o mimicking carcinomatosis
Acute renal colic :- On CT almost all stones are opaque but vary
considerably in density.
Study Number:
Subject’s Initials:
Subject’s Name:
Date of Birth/Age:
1. I confirm that I have read and understood the information sheet dated for the above
study and have had the opportunity to ask questions. ( )
2. I understand that my participation in the study is voluntary and that I am free to
withdraw at any time, without giving any reason without my medical care or legal rights
being affected.( )
3. I understand that the sponsor of the clinical trial, others working on the sponsor’s
behalf, the Ethics Committee and the regulatory authorities of the current study and any
further research that may be conducted in relation to it, even if I withdraw from the
trial. I agree to this access. However, I understand that my identity will not be revealed
in any information related to third parties or published. ( )
4. I agree not to restrict the use of any data or results that arise from this studyprovided
such a use is only for scientific purposes.
( )
5. I agree to take part in above study. ( )
Father’s name MR
Date of joining
Date of registration/
//
Investigator’s curriculum vitae
Qualification MBBS
Designation Postgraduation
अध्ययन शीर्षक:
अध्ययन संख्या:
चिर्य केप्रारंचिकअक्षर:
चिर्यकानाम:
पता:-
न्मकीचतचि / आयु:
(1) मैंपुचिकरता हंचक मैंनेसूिनापत्र पढ़ और सम चिया हैो उपयुषक्तअध्ययन केचिए चिनांचकतहैऔर मुप्रनेपूपूश्ने
कानेअिसर चमिा है।( )
(2) मैंसम ता हंचक अध्ययन मेंमेरीिागीिारी स्वैच्छिकहैऔर मैंचकसी िी समय अपनी िागीिारी िापस
िेनेकचिए स्वतंत्रहं।( )
(3)मैंसम ता हंचक नैिाचनकपरीक्षण केप्रायो क, प्रायो क की तरफ सेकाम करनेिािेअन्य, नैचतकता सचमचत और
ितषमानअध्ययन केचनयामक प्राचिकरण और इसकेसंबंिमेंचकए ा सकनेिािेचकसी सम्बंचित चिशी , ििे ही मैं प र र क्ष ण
सेचनकि ाऊं,परीक्षण को ारी रखा ा सकता है|मैंइसिक्तव्य सेसहमत हं। हािांचक, मैंसम ता हंचक मेरीपहिान
तीसरेपक्ष सेसंबंचितचकसी िी ानकारी मेंप्रकाचशत नहींहोगी। ()
ांिकताषका हस्ताक्षर: