RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, …



From,

Dr. Kshama S Hegde

Post Graduate in Department of General Surgery,

A.J. Institute of Medical Sciences,

Mangalore- 575004

To,

The Registrar,

Rajiv Gandhi University of Health Sciences,

Bangalore

(Through proper channel)

Sub: Submission of Synopsis of Dissertation

Respected Sir,

Herewith, I am submitting synopsis of my dissertation work “A CLINICAL STUDY ON ETIOLOGY,PROGNOSTIC OUTCOME AND ROLE OF ENDOSCOPY IN UPPER GASTROINTESTINAL BLEED” for the registration in Rajiv Gandhi University of Health Sciences, Bangalore.

Kindly accept the same and oblige.

Thanking you,

Yours faithfully,

(Dr. Kshama S Hegde)

Place: Mangalore

Date:15/10/12

CURRICULUM VITAE

Name : Dr. Ranjith Kumar Shetty B

Date Of Birth & Age : Apr 03,1968 – 43yrs

Present Designation : Professor

Department : General Surgery

College : A.J. Institute Of Medical Sciences

City : Mangalore

Residential Address : Flat No. 406,

Bon View Towers

Near Kadri Market

Mangalore-2

Phone & Fax Number With Code : Office : 0824-2225533

Residence : 0824-2217300

Mobile : 984504040

PAN Number : APWP53268M

Date Of Joining Present Institution : Oct 01,2003 as Assistant Professor

Qualifications:

|Qualification |College |University |Year |Registration No. Of UG & PG |Name Of The State Medical|

| | | | |With Date |Council |

|M.B.BS |Kasturba Medical College, Manipal |Mangalore university |Sep, 1991 |34771 |Karnataka Medical Council|

| | | | |Oct 22, 1992 | |

|MS(general surgery) |J.J.M Medical College, Davanagere |Kuvempu University |Sep, 1996 |34771 |Karnataka Medical Council|

| | | | |Jan 30,1997 | |

3. Details Of The Previous Appointments/ Teaching Experience

|Designation |Department |Name of Institution |From DD/MM/YY |To DD/MM/YY |Total Experience In Years |

| | | | | |& Months |

|PG Resident |General Surgery |J.J.M Medical College, Davanagere |Jun, 1993 |Jun,1996 |3 Years. |

|Assistant Professor |General surgery |K.S. Hegde Medical Academy, |Jan 01,1999 |Sep 30, 2003 |4 years |

| | |Deralakatte | | |9 months |

|Assistant Professor |General Surgery |A.J.Institute of Medical sciences,|Oct 01,2003 |Dec 31,2003 |3 Months |

| | |Mangalore | | | |

|Associate Professor |General Surgery |A.J Institute Of Medical Sciences,|Jan 01 ,2004 |Dec 31, 2007 |4 Years |

| | |Mangalore | | | |

|Professor |General Surgery |A.J. Institute of Medical | |Till Date | |

| | |Sciences, Mangalore | | | |

CURRICULUM VITAE

Name : Dr . Kshama S Hegde

Date of birth : July27th ,1986; 26yrs

Present designation : PG /Junior Resident

Department : General Surgery

College : A.J Institute of Medical Sciences

City : Mangalore

Nature of appointment : Full Time

Whether belongs to : Others

Present Address of employee : Resident Quarters,

No. 201,

AJIMS Campus

Date Of Joining Present Institution : June15th, 2012 as PG

Academic qualifications:

|Qualification |College |University |Year |Registration No. Of UG With |Name Of The State Medical |

| | | | |Date |Council |

|MBBS |SDM College of Medical Sciences and |RGUHS, |July |93273 |Karnataka Medical Council |

| |Hospital, Dharwad | |2010 | | |

|Internship |Kasturba Medical College |Manipal University |Oct 2011 | | |

3. Details Of The Previous Appointments/ Teaching Experience

|Designation |Department |Name of Institution |From DD/MM/YY |To DD/MM/YY |Total Experience In |

| | | | | |Years & Months |

|PG/Junior Resident |General surgery |A.J Institute of medical |June15th 2012 |Till date | |

| | |Science, Mangalore | | | |

SYNOPSIS

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

“A CLINICAL STUDY ON ETIOLOGY,PROGNOSTIC OUTCOME AND ROLE OF ENDOSCOPY IN UPPER GASTROINTESTINAL BLEED”

Name of the candidate : Dr. KSHAMA S HEGDE

Guide : Dr. RANJITH KUMAR SHETTY B

Course and Subject : M.S. (Gen.Surgery)

[pic]

Department of Gen.Surgery

A J Institute of Medical Sciences,

Kuntikana, Mangalore.

2011

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1 |Name of the candidate and address (in block letters) |DR.KSHAMA S HEGDE |

| | |POST GRADUATE RESIDENT,(MS) |

| | |DEPARTMENT OF GENERAL SURGERY, |

| | |A.J. INSTITUE OF MEDICAL SCIENCES, |

| | |MANGALORE. |

|2 |Name of the Institution |A. J. INSTITUTE OF MEDICAL SCIENCES MANGALORE. |

|3 |Course of study and Subject |M.S GENERAL SURGERY |

|4 |Date of admission to course |JUNE 15TH, 2012 |

|5 |Title of the Topic |

| |“” |

| |“A CLINICAL STUDY ON ETIOLOGY,PROGNOSTIC OUTCOME AND ROLE OF ENDOSCOPY IN UPPER GASTROINTESTINAL BLEED” |

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|BRIEF RESUME OF INTENDED WORK |

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|6.1 NEED FOR THE STUDY |

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|Upper gastrointestinal bleed is one of the most challenging and life threatening problems and requires emergency hospitalization.The overall mortality is |

|approximately 10%, increasing to 40 % in patients with other co-morbid illness. The prognostic outcome can be determined by Rockall scoring for risk |

|stratification. Precise determination of the location and type of bleeding is of great value to the surgeon. Thus endoscopy is crucial for diagnostic and |

|therapeutic purposes |

|REVIEW OF LITERATURE: |

|Clinicians have observed and recorded features of gastrointestinal haemorrhage for more than 500 years. The first description of a gastric ulcer is attributed to|

|Diodes of Caryastos in the 4th century BC. Gallen in the 2nd century AD described the symptoms and complications of peptic ulcer emphasising that haemorrhage was|

|commonly associated with black stools. Caelius Aurelianius appreciated that bleeding might arise from a variety of sources and recommended that the site should |

|first be identified before treatment is initiated. |

|Abercombie (1828) noted the difficulties in establishing an accurate diagnosis and described fatalities where no organic cause had been found and the source of |

|hemorrhage was undetected. In 1935 Avicenna gave the first description of the Mallory Weiss syndrome. Morgagni described a series of case histories and |

|pathological studies of gastric and duodenal ulceration and was the first to describe GI hemorrhage from portal hypertension.. |

|Blood transfusion became the most important advance in managing acute GI bleed only after the discovery of ABO blood group system by Loadsteiner. Methods of |

|donor blood transfusion described by Rons and Turner in 1916 and introduction of continuous drip infusion technique by Marriot and Kekwick made blood transfusion|

|a practical proposition. |

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|The first operation for upper GI bleed is credited to Mikulicz in 1881 and finally in 1937, Gordon Taylor was able to report on a large series of successful |

|operations. |

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|ENDOSCOPY: |

|The word Endoscopy is derived from the Greek “endo” meaning within and ‘skopein” – to view or observe. The earliest attempt at endoscopy was by Philip Bozzini, |

|who in 1806 devised a tin tube illuminated by a wax candle fitted with a mirror. Desmoreaux in 1867 described an open tube endoscope for genitourinary passage. |

|Adolf Kaussmaul, a German physician is generally credited with fashioning and employing the gastroscope. Bivan in 1868 extracted foreign bodies and saw |

|strictures in the oesophagus. Waldenberg in 1870 designed a longer instrument in which 2 tubes telescoped into each other for an easier introduction. |

|The real progress in endoscopy was the invention of an optical system. Nitze in 1879, Beneche(optician) and Eliter(instrument maker) made the first cystoscope. |

|Johann von Mickulicz in 1881 designed a tube that was slightly angulated in its distal one fourth as he realised the axis of he oesophagus is not the same as the|

|stomach. In 1898, Lange and Meltzing designed, used and reported the first results with a gastro-camera. |

|The 2nd phase of gastroscopy was introduced by Rudolf Schindler in 1920. He performed hundreds of gastroscopic examinations carefully documenting each procedure.|

|This led to the publication of Schindler’s monumental “Lehrbuch und Atlas der Gastroskopie”. He was then joined by George Wolf and this led to the invention the |

|famous Wolf-Schindler semi flexible gastroscope in 1932 and in 1937, Schindler published the first textbook “Gastroscopy” which turned out to be the gospel of |

|gastroscopy for a generation of clinicians. |

|The third phase of gastroscopy was initiated by Hirchowitz in 1957 with the introduction the flexible fibre glass gastroscope. |

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|6.3 OBJECTIVES |

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|To evaluate the indispensible role of endoscopy in diagnosing and management of upper GI bleed.. |

|To study the etiology of upper GI bleed |

|To assess the prognostic outcome using Rockall scoring .of risk stratification . |

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|7. MATERIALS AND METHODS |

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|7.1 SOURCE OF DATA |

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|A Prospective study in patients presenting with symptoms of upper GI bleed in A.J. Institute Of Medical Sciences, Mangalore, during the period of June 2012 to |

|November 2014.. |

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|7.2 METHODOLOGY OF STUDY |

|Definition of study subject: |

|Any patient with upper GI bleed |

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|Inclusion criteria: |

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|Age>16 with symptoms of upper GI bleed on presentation or ongoing several days before admission |

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|Exclusion criteria: |

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|Patients with upper respiratory bleed, paranasal sinuses bleed, lower GI bleed |

|Upper endoscopy is 90% to 95% diagnostic for acute upper GI bleeding.All patients with upper GI bleeding need an upper endoscopic examination to diagnose and |

|assess the risk posed by the bleeding lesion and to treat the lesion, reducing the risk of recurrent bleeding. |

|In patients presenting with acute hematemesis:. |

|. Appropriate hemodynamic assessment includes monitoring of heart rate, blood pressure, and mental status. Tachycardia at rest, hypotension, and orthostatic |

|changes in vital signs indicate a considerable loss of blood volume. Low urine output, dry mucous membranes, and sunken neck veins are also useful signs |

|If these signs of hypovolemia are present, the initial management focuses on treating shock and on improving oxygen delivery to the vital organs. This involves |

|repletion of the intravascular volume with intravenous infusions or blood transfusions with nasogastric tube insertion and Supplemental oxygen. |

|In the initial assessment if the nasogastric aspirate contains bright red blood then patient needs an urgent emergency endoscopy . if it is coffee brown then |

|endoscopic evaluation is planned within 24 hours. |

|The scoring systems are valuable for assessing patients with nonvariceal upper GI bleeding, as they predict the risk of death, longer hospital stay, surgical |

|intervention, and recurrent bleeding |

|Statistical analysis used: Chi Square Test and Fisher Exact Test12,13 |

|Study Design: a prospective of 50 patients |

|Duration of study: June 2012 to November 2014 |

| |

|7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY |

|ROUTINE INVESTIGATIONS REQUIRED: |

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|Complete haemogram, LFT,RFT,Serum electrolytes, coagulation profile |

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|SPECIAL INVESTIGATIONS REQUIRED: |

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|Upper GI endoscopy |

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|7.4 HAS THE ETHICAL CLEARANCE OBTAINED FROM YOUR INSTITUTION ? |

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|Clearance obtained. |

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|8. LIST OF REFERENCES |

|Bailey and Love ,Short practice of surgery, 25th edition ,2012 |

|Lenicke et al “Emergency Endoscopy in active upper gastro intestinal hemorrhage” Gastrointest. Endosc. 1976; 22: 228-229 |

|Rockall TA, Logan RF, Devlin HB, Northfield TC, Risk assessment after acute GI hemorrhage. Gut 1996; 38: 316-321 |

|Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding from a peptic ulcer. N Engl J Med 2008; 359: 928-937 |

|Corley DA, Stefen AM, Wolf M, Cook EF, Lee TH. Early indicators of prognosis in upper gastrointestinal haemorrhage. Am J Gastro enterol 1998; 93: 336-340 |

|Chak A, Cooper GS, Lloyd LE, Kolz CS, Barnhart BA, Wong RC. Effectiveness of endoscopy in patients admitted to the intensive care unit with upper |

|gastrointestinal hemorrhage. |

|Bjorkman DJ, Zaman A, Fennesty MB, Liberman D, Disario JA, Guest-Warnick G. Urgent versus elective endoscopy for acute non-variceal upper gastrointestinal |

|bleeding: An effectiveness study. Gastrointest Endosc 2004; 60: 1-8 |

|Yavorski RT, Wong RK, Maydonovitch C, Battin LS, Furnia A, Amundson DE. Analysis of 3,294 causes of upper gastrointestinal bleeding in military medical facility.|

|Am J gastro enterol 1995; 90:568-573 |

|Aljebrum AM, Fallone CA ,Barkun AN , Nasogastric Aspirate predicts high risk endoscopic lesions in patients with acute upper GI bleeding. Gastrointest Endosc |

|2004; 59:172-178. |

|Kovacs TO, Jensen DM. Endoscopic treatment of ulcer bleeding, Curr treat options. Gastroenterol 2007; 10:143-148 |

|Silverstein FG .et al , Gilbert DA et al “The National ASGE Survey on upper GI bleeding.” Gastrointest endosc, 1981; 27:73-79, 94-102 |

|William S. Hembrick, “History of endoscopy” Gastroesophageal Endoscopy by Sivak. |

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|9. Signature of the candidate |

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|10. Remarks of the guide |

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|11.Name and designation of |

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|11.1 Guide |

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|Dr. RANJITH KUMAR SHETTY B, M.B.B.S, M.S |

|PROFESSOR, |

|DEPARTMENT OF GENERAL SURGERY, |

|A.J. INSTITUTE OF MEDICAL SCIENCES |

|MANGALORE |

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|11.2 Signature |

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|11.3 Head of the department |

|DR ASHOK HEGDE M.B.B.S, M.S |

|PROF. & HEAD, |

|DEPARTMENT OF GENERAL SURGERY, |

|A.J. INSTITUTE OF MEDICAL SCIENCES |

|MANGALORE |

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|11.4 Signature |

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|12.1 Remarks of the Chairman and Principal |

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|12.2 Signature |

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|INFORMED CONSENT |

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|A J INSTITUTE OF MEDICAL SCIENCES, |

|KUNTIKANA, MANGALORE |

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|Informed consent form for the patients of “A.J Institute of Medical Sciences Kuntikana, Mangalore”, who will be participating in the research project (MS |

|dissertation) titled “ A CLINICAL STUDY ON ETIOLOGY, PROGNOSTIC OUTCOME AND ROLE OF ENDOSCOPY IN UPPER GASTROINTESTINAL BLEED” |

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|Name of Principal Investigator |

|Dr. Kshama S Hegde |

|Junior Resident. |

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|Name of Organization |

|Department of General Surgery, |

|A.J Medical Sciences, Kuntikana, Mangalore |

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|This Informed Consent Form has two parts: |

|Information Sheet (to share information about the research with you) |

|Certificate of Consent (for signatures if you agree to take part) |

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|You will be given a copy of the full Informed Consent Form |

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|PART I: Information Sheet |

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|Introduction |

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|I, Dr. Kshama s Hegde, Junior Resident in the department of General Surgery, A.J Institute of Medical Sciences, Kuntikana, Mangalore, is working on my MS |

|dissertation titled “ A CLINICAL STUDY ON ETIOLOGY, PROGNOSTIC OUTCOME AND ROLE OF ENDOSCOPY IN UPPER GASTROINTESTINAL BLEED” My study subjects will be patients |

|undergoing treatment for Upper GI bleed in the Surgery department of AJIMS. |

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|I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the |

|research. Before you decide, you can talk to anyone you feel comfortable with about the research. Your decision to participate or not to participate will not |

|have any effect on your treatment in our hospital. There may be some words that you do not understand. Please ask me to stop as we go through the information and|

|I will take time to explain. If you have questions later, you can ask them and get yourself clarified. |

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|Purpose of the research |

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|To show the Role of endoscopy in both diagnosis and management of Upper GI bleed . |

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|Type of Research Intervention |

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|It is a hospital based prospective study. All the patients undergoing treatment for Upper GI in the Surgery department of AJIMS in a time period of two years |

|will be enrolled in this study after providing informed consent to participation. |

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|Participant selection |

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|All the patients undergoing treatment for Upper GI bleed in Surgery department of AJIMS. |

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|Voluntary Participation |

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|Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, it will not|

|affect your treatment in our hospital. You have every right to withdraw at any stage in the research process. |

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|Procedures and Protocol |

|The objective of the study is to evaluate the role of endoscopy in Upper GI bleed . Written informed consent will be obtained from the patients agreeing to |

|participate in the study. |

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|Duration OCTOBER 2012 to OCTOBER 2014 |

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|Benefits |

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|Personally you will be benefited directly from the research by the economical and technical ease of this particular treatment modality. By taking part in this |

|research, you will be helping the scientific world to learn more about this treatment modality and its application in the field of surgery, when applied in the |

|study, which may possibly help in early diagnosis of cause of upper GI bleed. Thus, possibly assisting in the faster treatment and good outcome for the patient .|

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|Reimbursements |

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|You will not be given any money or gifts to take part in this research. |

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|Confidentiality |

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|The information that we collect from this research project will be kept confidential. Information about you that will be collected during the research will be |

|put away and no-one but the researchers will be able to see it. Any information about you will have a number on it instead of your name. |

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|Sharing the Results |

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|The knowledge that we get from doing this research will be shared with you. Confidential information will not be shared. We will publish the results in order |

|that other interested people may learn from our research. |

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|Right to Refuse or Withdraw |

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|You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your |

|choice and all of your rights will still be respected. |

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|Whom to Contact |

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|This proposal has been reviewed and approved by the Research and Ethical committee of A. J. Institute of Medical Sciences, Kuntikana, Mangalore, which is a |

|committee whose task it is to make sure that research participants are protected from harm. |

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|You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions? |

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|PART II: Certificate of Consent |

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|I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have |

|been answered to my satisfaction. I consent voluntarily to participate as a participant in this research. |

|Print Name of Participant__________________ |

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|Signature of Participant ___________________ |

|Date ___________________________ |

|Day/month/year |

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|If illiterate a literate witness must sign (if possible, this person should be selected by the participant and should have no connection to the research team). |

|Participants who are illiterate should include their thumb-print as well. |

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|I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm |

|that the individual has given consent freely. |

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|Print name of witness_____________________ AND Thumb print of participant |

|Signature of witness ______________________ |

|Date ________________________ |

|Day/month/year |

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|Statement by the researcher/person taking consent: |

|I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the |

|following will be done: |

|1. |

|2. |

|3. |

|I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered |

|correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and |

|voluntarily. |

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| A copy of this informed consent from has been provided to the participant. |

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|Print Name of Researcher/person taking the consent________________________ |

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|Signature of Researcher /person taking the consent__________________________ |

|Date ___________________________ |

|Day/month/year |

PROFORMA

CLINICAL STUDY ON ETIOLOGY,PROGNOSTIC OUTCOME AND ROLE OF ENDOSCOPY IN UPPER GASTROINTESTINAL BLEED ”

FORMAT OF PATIENT EXAMINATION

Case No. 2. I.P.No.

3. Patient’s Name 4. Age

5. Gender - Female 6. Occupation

7. Address

CHIEF COMPLAINT:

HISTORY OF PRESENTING ILLNESS:

PAST HISTORY:

FAMILY HISTORY:

PERSONAL HISTORY:

Sleep :

Appetite:

Bowel and bladder habbits:

GENERAL EXAMINATION :

State of nutrition & built:

PALLOR / ICTERUS / CLUBBING / CYANOSIS / EDEMA / LYMPHADENOPATHY:

BP : RR:

PR : SPO2:

EXAMINATION OF ABDOMEN :

EXAMINATION OF RESPIRATORY SYSTEM :

EXAMINATION OF CARDIOVASCULAR SYSTEM :

EXAMINATION OF CENTRAL NERVOUS SYSTEM :

INVESTIGATIONS

Data collection table:

|Hb | |

|LFT | |

|RFT | |

|SERUM ELECTROLYTES | |

|COAGULATION PROFILE | |

UGI SCOPY FINDINGS :

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:

Hb

LFT

RFT

SERUM ELECTROLYTES

UGI SCOPY

I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

  

 A copy of this informed consent form has been provided to the participant.

Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent_____________________

Date ___________________________

Day/month/year

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