Rajiv Gandhi University of Health sciences, bangalOrE, Karnataka
Annexure – ii
Synopsis for registration of subject for dissertation
1. / Name of the candidate and Address(In Block Letters) / Dr. ravindranath m meti
P.G. In GENERAL SURGERY
Dept of GENERAL SURGERY
Vims, Bellary
Pin – 583 104
2. / Name of the Institute / Vijayanagar institute of medical sciences, Bellary, Karnataka.
3. / Course of Study and Subject / Medical – M.S. In GENERAL SURGERY
4. / Date of Admission to Course / 16-08-2012
5. / Title of Topic / “Comparative study of endoscopic variceal ligation and endoscopic sclerotherapy in controll of bleeding in oesophageal varices in VIMS Bellary”.
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
The upper gastrointestinal bleeding is one of the most common surgical
emergencies that the surgeon encounters. Early diagnosis and accurate decision
regarding its management is very important.
Bleeding from esophageal varices can present to the clinician with one of the
most challenging therapeutic problems. Bleeding may be rapid and exsanguinating,
requiring urgent treatment for its control and resuscitation of the patient1
Approximately 1/3 of patients with portal hypertension experience upper GI
hemorrhage, and bleeding correlates with moderate to large sized gastroesophageal
varices. The mortality attending the initial variceal hemorrhage may be 50% in
untreated patients. Of those patients surviving their initial bleeding episodes
approximately one third rebleed within 6 weeks, and more than two-thirds will
rebleed within 1 year of initial bleed2.
The patients with cirrhosis of liver are already in a state of compromised
health status. Any additional surgical intervention will increase the morbidity and
mortality. Very few patients are in a condition to undergo major surgical procedures
like portacaval shunt. So simpler and safer procedures have evolved such as
sclerotherapy of varices, variceal band ligation, laser coagulation of varices etc.
Variceal injection sclerotherapy has emerged as the emergency intervention of
choice and accomplishes immediate control of variceal bleeding in 70% of cases2.
Endoscopic elastic banding ligation eradicates varices more rapidly, causes
fewer complications and has better long term survival than sclerotherapy3
REVIEW OF LITERATURE
For more than 5000 years, upper Gastro Intestinal bleeding is one of the
recognized causes of death. Various documents like Chinese manuscripts, Egyptian
papyri, medical works of Hippocrates and not to forget famous Indian Surgeon,
Sushruta, all have mentioned the upper gastrointestinal bleeding as one of the
conditions associated with very high mortality. But their main concentration was on
Peptic ulcers and not probably on esophageal varices. Morgagni in 1700 was the
first person to describe the gastrointestinal bleeding because of portal hypertension4.
Gustavo Oliveira Luz5done prospective study in 2011, that SCL and BL are equallyefficient for the control of acute variceal bleeding5.
In 1990, Saeed et al6employed endoscopic ligation in 12 actively bleeding
patients in whom the sclerotherapy had failed previously.
In 1991 AES Gimson etal7from institute of liver studies, Denmark proved variceal band ligation is a safe andeffective procedure, which obliterates the varices quickly and has a low rebleedingrate.
Matloff-DS8from Tufts University School of Medicine, Boston, employed
band ligation for the treatment of acute variceal bleeding and he found this procedure
to be as effective as sclerotherapy with negligible complications.
Terblanche J9from Department of Surgery University Capetown, South
Africa published a paper on endoscopic variceal band ligation for both acute bleeding
varices and for long-term management of varices.
Gold Schmiedt M et al10USA. Introduced the use over-tubes during
endoscopic ligation, which prevents the complications like esophageal perforation and
aspiration pneumonia.
Wong R.C11Endoscopy centre Brigham and women’s hospital Boston, USA
published a paper on band ligation. He found that the endoscopic variceal ligation is a
simple and reproducible method for emergency and elective treatment of varices.
Band ligation can be used prophylactically before the first life threatening
haemorrhage occurs.
Terblanche J et al12Department of Digestive Surgery, Regional Hospital-
France: commented that the endoscopic variceal ligation eradicated the varices with
fewer treatment sessions and negligible complications.
Jensen DM13studied regarding endoscopic screening for varices in cirrhosis
and concluded that stratification of cirrhotic patients into high and low risk groups for
prediction of first variceal hemorrhage is feasible with clinical and endoscopic
parameters. It is logical to screen for and offer high-risk patients safe and effective
endoscopic or medical therapies to prevent first esophageal hemorrhage.
American college of gastroenterology practice parameter committee
recommended band ligation as the endoscopic treatment of choice for long term
management of variceal hemorrhage. Combination therapy although not
recommended for initial bleeding has shown promising results in recurrent bleeds.Several studies and meta-analysis compared endoscopic injection sclerotherapy with endoscopic variceal ligation for the treatment of bleeding esophageal varices14,15 They generally demonstrated that ligation and sclerotherapy are equally effective in controlling variceal bleeding but ligation is associated with a lower incidence of complications,fewer episodes of a recurrent bleeding,and fewer sessions to obliterate varices.
6.3 OBJECTIVES OF STUDY
- To diagnose the cases of esophageal varices
- To compare between sclerotherapy and banding for control of bleeding in esophageal varices by endoscopy.
- To know the eradication rate of varices
- To study different complications of this treatment.
7 / MATERIAL AND METHODS.
7.1(a) SOURCE OF DATA
This is a prospective study. All the patients with inclusion criteria attending to department of surgeryVIMS medical hospital Bellary from September2012 to September 2014 (24Months) will be included.
(b) STUDY SUBJECTS
Patients with inclusion criteria admitted/attending to department of surgery will be studied.
(c)INCLUSION CRITERIA
Patients olderthan 18 years and with signs of upper GI bleeding for
more than 24 h (confirmed hematemesis and melena)
Those who give consent for the study.
(d) EXCLUSION CRITERIA
1. Patients with prior endoscopic treatment.
2. Patients with previous surgical treatment for portal hypertension
3.All patients with diagnosed coagulation disorders
4. patients in decompensated cirrhosis(hepatic encephalopathy)
(e)SAMPLE SIZE
50 patients with inclusion criteria will be studied from September 2012 to September 2014 (24Months)
7.2 METHODS OF COLLECTION OF DATA
The patientswith inclusion criteria will be subjected to upper GI endoscopy for identification and location of varices and grouped into group A and group B. Group A will be subjected for slerotherapy using 3% setrol (sodium tetradecyl sulfate)
diluted with saline to 1% solution. technique and group B will be subjected for banding technique to control the bleeding. Both groups will be compared using appropriate statistical tests in terms of effectiveness, complications, procedural time and patient recovery.
7.3 Does the study require any investigation or intervention to be conducted on patients,other humans or animals? If so please describe briefly?
YES:Complete history, clinical examination
Routine bloodinvestigations:Complete blood Count, HBSAg, HIV,
Specific investigations like, endoscopy, LFT, USG abdomen/CT
depending on need according to provisional clinical diagnosis.
All the investigations and interventions will be done under the direct guidance and supervision of Thesis Guide.
7.4 Has ethical clearances been obtained from your institution in case of
YES, Ethical clearance has been obtained from VIMS Institutional Ethics committee, VIMS, Bellary.
8. / List of References
1)Burnet DA, Rikkers LF. Non-operative emergency treatment of variceal
hemorrhage. Surg Clinics N Am 1990; 70 (2): 291-306.
2) Stabile BE, Stamos MJ. Gastrointestinal bleeding. In: Zinner MJ, Schwartz SI,
Ellis H, ed (s). Maingot’s Abdominal Operaitons, 10th edition, USA: Appleton
and Lange, 1997: 289-313.
3) Stiegmann GV. Endoscopic management of esophageal varices. In: Greene FL,
Ponsky JL, ed(s).Endoscopic Surgery. Philadelphia: W.B. Saunders, 1994:
112-124.
4) Friddian Green RG, Turcott JG. Gastrointestinal haemorrhage. A subsidiary of
Harcourt Brace Javanovian Publishers, 1980:10-27.
5)Gustavo Oliveira Luz, Fauze Maluf-Filho, Sérgio Eiji Matuguma, Fábio Yuji Hondo, Edson Ide, Jeane Martins Melo, Spencer Cheng, Paulo Sakai Comparison between endoscopic sclerotherapy and band ligation for hemostasis of acute variceal bleeding. May 2011.
6)Saeed ZA, Michaletz-Onody PA. Endoscopic variceal ligation in patients who
have failed endoscopic sclerotherapy. Gastrointestinal Endos 1990; 36 (6):
572-4
7) Gimson AE, Ramage JK, Panos MZ, Hayllar K, Harrison PM, Williams R,
Westaby D. Randomized trial of variceal band ligation versus injection
sclerotherapy for bleeding oesophgeal varices. Lancet 1993; 342: 391-4.
8) Matloff DS. Treatment of acute variceal bleeding. Gastroenterol Clini North Am
1992; 21 (1): 103-18.
9) Terblanche J. Issues in gastrointestinal endoscopy: esophageal varices: injet,
band, medicate or operate. Scand-J-Gastroenterol 1992; 192: 63-6.
10) Goldschmiedt M, Haber G. A safety maneuver for placing overtube during
endoscopic variceal ligation. Gastrointestinal Endos 1992; 38 (3): 399-400.
11) Wong RC, Carr-Locke DL. Endoscopic band ligation of esophageal varices.
Gastroenterologist 1993; 1 (3): 177-84.
12) Terblanche J. Issues in gastrointestinal endoscopy: esophageal varices: injet,
band, medicate or operate. Scand-J-Gastroenterol 1992; 192: 63-6.
13) Jenson DM. Endoscopic screening for varices in cirrhosis: findings,
implications, and outcomes. Gastroenterology 2002; 32 (4): 1079-1105.
14)zargar SA,Javed G, khan BA, Et al. Endoscopic ligation compared with sclerotherapy for bleeding esophageal varices in children with extrahepatic portal venous obstruction. Hepathology 2002;36;666-72.
15) Gross M, schiemann U, Muhlhofer A,et al. Meta-analysis: efficacy of therapeutic regimens in ongoing variceal bleeding. Endoscopy 2001;33;737-46.
16) Injection therapies for varicial bleeding dis orders of GI tract Walter G. Park,MD, Ronald W.Yeh,MD George Triadafilopoulos,MD Stanford,California,USA;Volume 67,No.2 :2008 GASTROINTESTINAL ENDOSCOPY
9. / Signature of the candidate
10. / Remarks of the guide
11. / Name & designation (in block letters)
11.1 Guide / Dr. M. SHIVAPRASAD
professor
DEPARTMENT OF GENERAL SURGERY
vims, bellary
11.2 Signature
11.3 Co-guide (if any)
11.4 Signature
11.5 Head of the
Department / Dr. VIDYADHAR KINhAL
Prof. & HOD,
departmentOFGENERAL SURGERY
Vims, Bellary
11.6 Signature
12. / 12.1 remarks of the
chairman & principal
12.2 SIGNATURE
FROM, date: 25/09/2012
THE PROFessor AND HEAD OF THE DEPARTMENT
DEPARTMENT OF GENERAL SURGERY
VIMS, BELLARY.
TO,
THE PRINCIPAL,
VIJAYNAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY.
Through proper channel
Sir,
As per the regulations of the University of the Dissertation topic, the following post graduate student in M.S DEGREE IN GENERAL SURGERY has been allotted the Dissertation topic as follows by the official registration committee of all qualified and eligible guides of the Department ofGeneral Surgery.
NAME / TOPIC / GUIDEDr.RAVINDRANATH M METI
P.G. In GENERAL SURGERY Dept of GENERAL SURGERY
Vims, Bellary
Pin – 583 104 / “Comparative study of endoscopic variceal ligation and endoscopic sclerotherapy in controll of bleeding in oesophageal varices in VIMS Bellary” / Dr. M .SHIVA PRASAD
professor
DEPARTMENT OF GENERAL SURGERY vims, bellary
Therefore I request you kindly to communicate the acceptance of the dissertation topic allotted to the P.G student at an early date.
Thanking you yours faithfully,
Dr. VIDYADHAR KINhAL
Prof. & HOD,
departmentOF GENERAL
SURGERY
Vims, Bellary.
FROM, date:25/11/2010
THE PROFessor AND HEAD OF THE DEPARTMENT
DEPARTMENT OF general surgery
VIMS, BELLARY.
TO,
THE REGISTRAR,
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE,
KARNATAKA.
Through proper channel
Sir,
As per the regulations of the Universityfor the registration of the Dissertation topic, the following post graduate student in M.S DEGREE IN GENERAL SURGERY has been allotted the Dissertation topic as follows by the official registration committee of all qualified and eligible guides of the Department ofGeneral Surgery.
NAME / TOPIC / GUIDEDr.RAVINDRANATH M METI
P.G. In GENERAL SURGERY Dept of GENERAL SURGERY
Vims, Bellary
Pin – 583 104 / “Comparative Study of endoscopic variceal ligation and endoscopic sclerotherapy in controll of bleeding in oesophageal varices in VIMSBellary” / Dr. M .SHIVA PRASAD
professor
DEPARTMENT OF GENERAL SURGERY
vims, bellary
Therefore I request you kindly to communicate the acceptance of the dissertation topic allotted to the P.G student at an early date.
Thanking you yours faithfully,
Dr.VIDYADHAR KINhAL
THE PROFESSOR AND HOD
DEPARTMENT OF SURGERY
VIMS BELLARY
FROM, date:25/09/2012
dr. RAVINDRANATH M METI
PG IN GENERAL SURGERY
DEPARTMENT OF GENERAL SURGERY
Vims, BELLARY
PIN-583104
TO,
THE PRINCIPAL,
VIJAYNAGAR INSTITUTE OF MEDICAL SCIENCES,
BELLARY.
THROUGH PROPER CHANNEL
Respected sir,
Sub: ACCEPTANCE, REGISTRATION AND FORWARDING OF TOPIC
In accordance of the above cited topic, I the undersigned studying in P.G course in M, S DEGREE IN GENERAL SURGERY have been allotted the Dissertation topic “Comparative study of endoscopic variceal ligation and endoscopic sclerotherapy in controll of bleeding in oesophageal varices in VIMS Bellary”under the guidance of Dr.SHIVA PRASAD, THE PROFESSOR, dEPT.ofGENERAL SURGERY, vims, bellary.
I request you to kindly forward the dissertation topic in the prescribed form to the University for Approval.
Thanking you, yours faithfully
(DR.RAVINDRANATH M METI)
THESIS GUIDE
Dr. M .SHIVA PRASAD
professor
DEPARTMENT OF GENERAL SURGERY
vims, bellary