RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE AND ADDRESS / DR. BIJU ISLARY
PG STUDENT, MS GENERAL SURGERY
ROOM NO.307, PG MEN’S HOSTEL, HOSPITAL ROAD, SHIVAJINAGAR,
BANGALORE-560001.
2. / NAME OF THE INSTITUTION / BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE.
3. / COURSE OF STUDY AND SUBJECT / M.S. IN GENERAL SURGERY
4. / DATE OF ADMISSION TO THE COURSE / 1ST JUNE, 2012
5. / TITLE OF THE TOPIC / A STUDY TO EVALUATE THE CLINICAL PROFILE AND MANAGEMENT OF DUODENAL ULCER PERFORATION IN ELDERLY PATIENTS.
6. / BRIEF RESUME OF THE INTENDED WORK:
6.1. NEED FOR THE STUDY:
According to the United Nations, age of 60 years and above are referred to as elderly person in developing countries.1
Perforation complicates duodenal ulcer about half as often as bleeding and most perforated ulcers are on the anterior surface of the duodenum. The risk also increases with age older than 60 years, patients having a prior GI event, or concurrent use of steroids or anti-coagulants.2 Helicobacter pylori is implicated in 70–92% of all perforated duodenal ulcers even if those secondary to Non-Steroidal Anti-inflammatory Drugs are included.
Prompt recognition of the condition is very important and only by early diagnosis and treatment, it is possible to reduce morbidity and mortality.
Hence, an attempt is made to analyze the various factors, which are affecting the incidence, outcome of management, morbidity and mortality of patients with duodenal ulcer perforations in elderly patients.
6.2. REVIEW OF LITERATURE:
In Maingot’s Abdominal Operation, Timothy J. Broderick and Jeffrey B. Matthews states that in older patients, admission rates for duodenal ulcer perforation increased and gastric ulcer perforation decreased in the last decade. Duodenal perforation currently accounts for approximately 75% of peptic perforation and the mortality rate of perforated ulcer is higher in the elderly.3
In Sabiston Textbook of surgery, David M. Mahvi and Seth B. Krantz states that it is now believed that 90% of duodenal ulcer is associated with H. pylori infection.2
In Bailey and Love’s Short Practice of Surgery, Primrose N John states that an erect plain chest radiograph will reveal free gas under diaphragm in >50% of cases.4
Uccheddu A et.al states that the duration of symptoms is a known factor that influences the prognosis after surgery for perforated peptic ulcer. This factor is still the most important in the elderly being responsible of the high mortality rate. The delay in treatment is due to a delayed hospitalization of old patients, who show a low reactivity to the disease.5
In the study done by Gutiérrez de la Peña et.al, it is found that the treatment of the perforated duodenal ulcer continues to be a controversial subject. The comparison of the results of simple closure of perforated duodenal ulcer versus treatment by truncal vagotomy and pyloroplasty shows that simple closure remains the selected treatment in the majority of patients who present with a perforated duodenal ulcer. The operation is a simple and safe procedure.6
O'Riordain DS et.al conclude that perforated duodenal ulcer is associated with a high mortality and morbidity in the elderly. Efforts to reduce mortality and morbidity should be aimed at accurate diagnosis and early surgical intervention.7
Arveen S et.al states that perforated peptic ulceris one of the most common surgical emergencies in South India. The high incidence of complications necessitates the identification of factors associated with the morbidity and mortality of patients undergoing surgery forperforated peptic ulcer.8
Perforated duodenal ulcer is a major complication of chronic peptic ulcer disease. Simple omental patch by open method and helicobacter pylori eradication therapy is sufficient to prevent reperforation.9,10
6.3. AIMS AND OBJECTIVES OF STUDY:
This research work is intended:
1.  To study the incidence and management of duodenal ulcer perforation and association of H. pylori with duodenal perforation in elderly patients.
2.  To evaluate the morbidity and mortality associated with duodenal ulcer perforation in elderly patients.
7. / MATERIALS AND METHODS:
7.1. SOURCE OF DATA:
Patients admitted in Victoria hospital and Bowring & Lady Curzon hospital attached to Bangalore Medical College & Research Institute from November 2012 to October 2014, a total of 30 cases for 2 years.
7.2. METHOD OF COLLECTION OF DATA:
After hospitalization data to be collected regarding patient’s socio-demographic profile, clinical history, examination, relevant diagnostic investigations, operative procedure and post-operative complications.
A) STUDY DESIGN: Prospective study.
B) STUDY PERIOD: November 2012 to October 2014.
C) PLACE OF STUDY: Victoria hospital and Bowring & Lady Curzon hospital attached to Bangalore Medical College and Research Institute.
D) SAMPLE SIZE: 30 cases.
E) INCLUSION CRITERIA:
- Patients of age 60 years and above.
- Patients of both sexes.
- Patient presenting with symptoms and signs of peritonitis who are found to have duodenal ulcer perforation.
F) EXCLUSION CRITERIA:
- Age less than 60 years.
- GI tract Perforation involving other than duodenum
- Traumatic perforation.
G) STUDY METHODOLOGY:
A total of 30 patients presenting to Victoria hospital and Bowring & Lady Curzon hospital from November 2012 to October 2014 with features suggestive of perforation peritonitis, are admitted, analyzed and managed accordingly.
H) ASSESSMENT TOOLS:
The outcome variables are incidence of duodenal ulcer perforation in elderly patients, incidence of association of H. pylori (IgG serological test) with duodenal perforation, mean operative time, complications like wound infection, respiratory complication and ileus.
I) STATISTICAL METHOD:
Data will be analyzed using SPSS (version 17).
7.3. DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENT OR OTHER HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY.
A) It does not require any intervention on animals.
B) Investigations will be done on patients only after taking their consent.
1) Hematological: Hemoglobin, Total leucocyte count, Differential count, Erythrocyte sedimentation rate, Platelet count.
2) Blood urea, Serum creatinine and Serum electrolytes.
3) Random Blood sugar, Fasting blood sugar, Post-prandial blood sugar.
4) Blood grouping & cross matching, Bleeding Time, Clotting Time.
5) Erect Abdomen X-ray, Chest X-ray PA view.
7) Electrocardiogram.
8) Culture and sensitivity of peritoneal collection.
9) H. pylori test (IgG serological test).
10) Ultrasonography of abdomen (optional).
11) CT scan abdomen (optional).
7.4. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
YES
8. / LIST OF REFERENCES:
1.  World Health Organization Definition of an older or elderly person [Internet] 2012. Available from: http://www.who.int/healthinfo/survey/ageingdefnolder/en/index.html
2.  David M. Mahvi, Seth B. Krantz, Stomach. In: Townsend, Beauchamp, Evers, Mattox, Sabiston Textbook of surgery. 19th ed. Elsevier; 2012: Vol.2:1191-1198.
3.  Timothy J. Broderick, Jeffrey B. Matthews, Ulcer complications. In: Michael J. Zinner, Stanley W. Ashley, Maingot’s Abdominal Operation. 11th ed. McGraw Hill; 2007:357-361.
4.  Primrose N John, Stomach and duodenum. In: Norman S. Williams, Christopher J.K. Bulstrode, P. Ronnan O’connell, Bailey and Love’s Short Practice of Surgery. 25thed. Hodder Arnold; 2008:1054-1063.
5.  Uccheddu A, Floris G, Altana ML, Pisanu A, Cois A, Farci SL. Surgery for perforated peptic ulcer in the elderly. Evaluation of factors influencing prognosis. Hepatogastroenterology. 2003 Nov-Dec; 50(54):1956-8.
6.  C. Gutiérrez de la Peña, R. Márquez, F. Fakih, E. Domínguez-Adame, J. Medina et.al. Simple Closure or Vagotomy and Pyloroplasty for the Treatment of a Perforated Duodenal Ulcer, Comparison of Results. Dig Surg 2000; 17:225-228.
7.  O'Riordain DS, O'Dwyer PJ, O'Higgins NJ. Perforated duodenal ulcer in elderly patients. J R Coll Surg Edinb. 1990 Apr; 35(2):93-4.
8.  Arveen S,Jagdish S,Kadambari D. Perforated peptic ulcer in South India: an institutional perspective. World J Surg 2009; 33(8):1600-1604.
9.  Nuhu A, Kassama Y. Experience with acute perforated duodenal ulcer in a West African population. Niger J Med. 2008 Oct; 4:403-6.
10.  Enders K. W. Ng, Y. H. Lam, Joseph J. Y. Sung, M. Y. Yung, K. F. To, Angus C. W. Chan, Danny W. H. Lee, Bonita K. B. Law, James Y. W. Lau, Thomas K. W. Ling, W. Y. Lau, and S. C. Sydney Chung. Eradication of Helicobacter pylori prevents recurrence of Ulcer after simple closure of duodenal ulcer perforation: randomized controlled trial. Ann Surg. 2000 Feb; 231(2):153–58.
9. / SIGNATURE OF THE CANDIDATE:
10. / REMARKS OF THE GUIDE:
Nowadays, due to the injudicious use of NSAIDs, alcohol abuse and H. pylori infection, peptic ulcer disease is common, but duodenal ulcer perforation is on the rise following peptic ulcer disease. Hence early diagnosis and treatment helps to reduce the morbidity and mortality. So I recommend to conduct a study on duodenal ulcer perforations in elderly age group.
11. / NAME AND DESIGNATION OF (IN BLOCK LETTERS):
11.1. GUIDE: / DR. SHASHIKALA C. K., M.S.
ASSTT. PROFESSOR
DEPTT. OF GENERAL SURGERY,
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE.
11.2. SIGNATURE & SEAL:
11.3. HEAD OF DEPARTMENT: / DR. B. S. SHIVASWAMY, M.S.
PROFESSOR & HOD
DEPTT. OF GENERAL SURGERY,
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE.
11.4. SIGNATURE & SEAL :
12. / REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.1. DEAN CUM DIRECTOR: / DR O.S. SIDDAPPA, M.S., M.Ch.
DEAN CUM DIRECTOR,
BANGLORE MEDICAL COLLEGE AND RESEARCH INSTITUTE,
BANGALORE.
12.2. SIGNATURE AND SEAL:

To, Dated: 13/11/12

The Chairman

Ethical committee,

BMCRI, Bangalore-2.

Respected Sir,

This is to inform you that I will bear the cost of IgG serological test for H. pylori which will be done on patients for my thesis purpose.

Thanking you,

Yours faithfully,

Dr. Biju Islary

PG in MS General Surgery,

BMCRI, Bangalore.