RAJIV GANDHI UNIVERSITY OF

HEALTH SCIENCES – KARNATAKA,BENGALURU

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / Name of the Candidate &
Address
( in block letters) / Dr.VENKATESH S.P.
331/1,M.R.K.Street,
Indira Nagar,
Neyveli – 607 801
Tamil Nadu .
2. / Name of the Institution / J.S.S. MEDICAL COLLEGE , MYSORE
3. / Course of Study & Subject / M.S.GENERAL SURGERY
4. / Date of Admission to Course / 31-05-2008
5. / Title of the Topic / A Comparative study of Chest tube Insertion Versus Video Assisted Thoracoscopic Surgery as primary mode of treatment inFibrinopurulent stage of Empyema Thoracis.
6. / BRIEF RESUME OF WORK,INTENDED
(6.1) NEED FOR STUDY
For centuries, Empyema has been recognized as a serious problem. Despite the introduction of broad spectrum antibiotics and better antitubercular treatment, there are still a considerable number of patients getting admitted with the diagnosis of Empyema Thoracis especially in developing countries like ours. The optimal treatment of this condition especially in the fibrinopurulent phase(stageII) remains controversial so as to whether to go for a non - operative regimen (antibiotics, thoracentesis and chest tube drainage) or an early operative regimen (Video assisted Thoracoscopic Surgery and Decortication ).While the former mode is less invasive and cheap, it is not clearly proved that it is better than the more invasive later mode of treatment in terms of conversion into thoracotomy,morbidity and duration of Hospital stay.1
Thus the need for this study is to compare the efficacy of both treatment modalities in terms of morbidity and cost effectiveness and to identify the optimal way of managing the condition in our set up.
(6.2) REVIEW OF LITERATURE
The term “Empyema” comes from the Greek word “empyein” meaning “pus producing”. Empyema Thoracis is the condition in which pus and fluid from infected tissue collects in the pleural cavity. The causes are many but the most common is a pneumonia; others are trauma, esophageal perforation, surgical procedure on pleural space and septicemia.5 It is classified into three categories based on the chronicity of the disease process:
Stage I - Acute Exudative phase
Stage II - Transitional Fibrinopurulent phase
Stage III - Chronic Organizing phase.7
Around 500 BC, Hippocrates recommended treating empyema with open drainage. Since then, the treatment of Empyema remained essentially unchanged until the middle of the 19th Century.In 1876, Hewitt described a method of closed drainage of the chest in which a rubber tube was placed into the empyema cavity and drained via the water seal drainage.In the early
20th Century, surgical therapies for empyema ( ex:Thoracoplasty, Decortication) were introduced.5Since the introduction of minimally invasive surgical techniques in thoracic surgery in 1990,Video Assisted Thoracoscopic Surgery (VATS) has become the approach for many thoracic operations.4
In 1999, Hurtgen et al in their article “Video assisted thoracic Surgery: Has technology found its place?”stated that VATS is gaining importance especially in the fibrinopurulent phase of Empyema thoracis but evaluation of this access compared with mere chest tube drainage remains unsatisfactory.3
In 1997, Wait et al did a randomized trial of empyema therapy and concluded that VATS is associated with a higher efficacy, shorter hospital duration and less cost in the treatment of empyema.8
In 1998, Scherer et al did a study of VATS in the treatment of post traumatic empyema and concluded that VATS reduces morbidity and hospital stay and so believed that it should be the initial operative approach to trauma patients with suspected post traumatic empyema.6
In 2002, Coote did a study on Surgical versus non surgical management of pleural empyema and concluded that it might appear that VATS is superior to chest tube drainage for large, loculated pleural empyema in terms of duration of chest tubes in situ and hospital stay but the validity is questionable and there are risks of complications such as performing under General Anaesthesia and one lung ventilation.1
In 2000, Helfritzsch analysed the treatment of pleural empyema between 1992-1998 in a German Hospital and concluded that Stage I is best treated with simple chest tube drainage,Stage II is efficiently treated by VATS and in Stage III the method of choice is open decortication.2
(6.3) OBJECTIVES OF THE STUDY
  1. To compare the effectiveness of chest tube insertion versus VATS as primary mode of treatment in fibrinopurulent stage of empyema thoracis in terms of duration of chest tube in situ, duration of Hospital stay & cost of treatment.
  2. To compare the complications and morbidity associated with both the modes of treatment.
  3. To compare the treatment failure in both the options in terms of rate of
conversion into VATS/thoracotomy in the ICD group and that
to thoracotomy in the VATS group.
7. / MATERIALS & METHODS
(7.1)SOURCE OF DATA :-
The sources of data for the study are those patients getting
admitted with the diagnosis of Empyema thoracis in the fibrinopurulent stage in JSS Hospital,Mysore meeting the inclusion and exclusion criteria as mentioned later, during the study period Dec 2008 to Oct 2010.
(7.2)METHOD OF COLLECTION OF DATA :-
The data is to be collected by history, clinical examination,
investigations including imaging modalities and pleural fluid analysis and postoperative follow up of the patients with a profoma.
MODE OF SELECTION OF CASES AND METHOD OF ANALYSIS:-
The selection of cases will depend on age, diagnosis, imaging results, thoracentesis results, general condition at the time of admission and comorbid diseases and the selection will be done by a purposive sampling technique. A total number of 40 cases will be studied with randomly assigned 20 cases in both groups. A written consent will be obtained from all the patients to undergo the necessary investigations and the surgical interventions.
The study is a comparative study between the two modes of treatment. The following variables will be compared:
*Duration of chest tube in situ
*Duration of hospital stay
*Cost of treatment
*Complications
* Treatment failure
*Mortality
The following statistical methods will be employed:
  1. Descriptive statistics
  2. Chi-square test
  3. Contingency coefficient analysis
  4. Independent samples ‘t’ test
The statistical calculations will be done using Minitab for Windows software.
INCLUSION CRITERIA
Patients both adults and children diagnosed as Empyema Thoracis in fibrinopurulent stage based on clinical examination , imaging modalities and pleural fluid analysis.
EXCLUSION CRITERIA
* Empyema due to carcinoma
* Terminally ill patients
* Patients with severe respiratory distress
* Patients not fit for surgery
* Patients with comorbid diseases like cardiac disorders and
Immunosuppression.
(7.3)Does the study require any investigations or interventions to be conducted on patients ?
Yes, the study requires the following investigations and
interventions:
  • Thoracentesis
  • Basic investigations and imaging modalities such as X-rays and CT scan
  • Surgical interventions such as Chest tube insertion and Video assisted thoracoscopic surgery

(7.4)Has ethical clearance been obtained from your institution ?
Yes, obtained from Ethical committee, JSS Medical College,
Mysore.
8. / LIST OF REFERENCES : -
  1. Coote N., Surgical versus non surgical management of pleural empyema,
Cochrane database syst Rev.2002;(2):CD001956
  1. Helfritzsch H., Lesser T., Seifert S.et al., Stage adapted therapy of pleural
empyema, Zentralbl Chir.2000;125(5):454-458
  1. Hurtgen M., Witte B., Friedel G.et al., Video assisted thoracoscopic access
in pleural empyema compared with mere chest tube drainage,
Chirurg.1999 Apr;70(4):464-468
  1. Mack J., Scruggs R., Kelly M. et al., Video assisted Thoracic Surgery: Has
Technology Found its Place?, Ann Thorac surg.1997;64:211-215
  1. Sat Sharma. emedicine.com/med/topic659.htm, Pleural disorders :
Empyema, Pleuropulmonary
  1. Scherer LA., Battistella FD., Owings JT. et al., VATS in the treatment of
post traumatic empyema, Arch Surg.1998 Jun;133(6):637-641
  1. Lukanich M. and Sugarbaker J., Chest wall and Pleura, Townsend M.,
Beauchamp R., Evers B. et al., Sabiston textbook of Surgery,
17th edition. Philadelphia, PA:WB Saunders, 2004, Vol 2:1725
  1. Wait MA., Sharma S., Hohn J.et al., A randomized trial of empyema
Therapy, Chest 1997 Jun;111(6):1548-1551
9. / Signature of the Candidate :
10. / Remarks of the Guide : / Empyema thoracis, a common condition in our country, needs evaluation of the efficacy of management by minimal invasive procedure i.e., VATS. Hence this study has been taken up.
11.



12. / Name & Designation of
(in block letters)
(11.1) Guide
(11.2) Signature
(11.3) Co-Guide (if any)
(11.4) Signature
(11.5) Head of Department
(11.6) Signature / Dr. B.J. SHARATH CHANDRA. M.S.,
PROFESSOR,
DEPARTMENT OF GENERAL SURGERY,
JSS MEDICAL COLLEGE & HOSPITAL,
MYSORE.
__
Dr. G. SIDDESH. M.S.,
PROFESSOR AND HEAD,
DEPARTMENT OF GENERAL SURGERY,
JSS MEDICAL COLLEGE & HOSPITAL,
MYSORE.
(12.1) Remarks of the
Chairman & Principal
(12.2) Signature

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