RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE IIPROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS. / DR.B.N HANUMANTHAPPA
PG IN GENERAL SURGERY
KIMS,
HUBLI – 580022
2. / NAME OF THE INSTITUTION. / KARNATAKA INSTITUTE OF MEDICAL
SCIENCES, HUBLI
3. / COURSE OF STUDY AND SUBJECT / M.S. GENERAL SURGERY
4. / DATE OF ADMISSION / 21-05-2012
5. / TITLE OF THE TOPIC / “CLINICAL STUDY ON ASSESMENT OF POST SURGICAL COMPLICATIONS ACCORDING TO CLAVIEN DINDO CLASSIFICATION IN MAJOR ABDOMINAL SURGERY”
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
Complication occur in every surgical department, no operation without complication. so surgical complication needs to classified and evaluated. when a new surgical procedure are introduced or when several surgical approaches exists for one procedure, there is need to compare outcomes and complication for each specific approach in a sound and reproducible way. although quality assesement gaining increasing attention, still there is no consensus on how to define and grade postoperative complication. A new classification intiated by Clavien which is been updated regularly.The classification based on the type of therapy needed to correct the complication. The priniciple of the classification was to be simple, reproducible and applicable irrespective of the cultutral background. The aim of the current study is to critically evaluate this classification and to correlate the classification grades in each patients and each procedure.so, Clavien-Dindo classification is the simple way of reporting all complications. It allow us to distinguishing a normal postoperative course from any deviation and the severity of the complication and it may be useful for comparing postoperative morbidity in each patients.Our main aim of study is to test the usefullness of Clavien-Dindo classification in patient undergoing the abdominal surgery.
6.2 REVIEW OF LITERATURE:
· Pierre Clavein MD et al l study on proposed classfication of complication of surgery with examples of utility in cholecystectomy, studied done on 650 patients they have presented an systemic approach to the classification and its possible uses advantages and its disadvantages and standardised complication scoring system.
· Daniel Dindo ,MD, Nicolas Demartines,MD and pierre-Alan Clavein,MD an orginal article2 of clasification of surgical complications, study conducted on 6336 patients, concentrated mainly on major surgery eg: liver surgery, colon surgery, pancreatic sugery etc. conclusion was that the new complication classification appears reliable and may represent a compelling tool quality assesement in surgery in all part of world.
· Michelle L.Deoliveira,MD et al3 study on assessment of complications after Pancreatic surgery,A Novel grading system applied to 633 patients undergoing Pancreaticoduodenectomy demonstrated the applicability and utility of a new classification in grading complications following pancreatic surgery.and enabling meaningful comparison among different centers.
· B.Liu, Yan et al4 study on using Clavein grading system to classify the complication of the right hepatectomy in living donors, study analysed on 160 patients, shown that the clavein grading system is useful compraise for surgical outcomes.
· Clavein pierre et al5 study of five year experience of clavein-dindo classification of surgical complication, collected reports from the literature from 7 centres with different continents. they provided the strong evidence that the classification is valid and applicable world wide in many fields of surgery.
· AndrewJ.E, Seely MD et al6 study on systematic classification of morbidity and mortality after thoracic surgery, on 2010, concluded that this standardised classification system for identifying presences and severity of thoracic surgical complications is feesible, facilities objective comparison, identifies burden illness of individual and provides an effective method for continuous surgical quality assesement.
· Riccardo casadei, claudio Ricci et al7 study on assessment of complications according to clavein-dindo classification after distal pancreatectomy. study conducted on 61 patients who undergoing distal pancreatectomy. concluded that clavein –dindo classification is a simple way of reporting all complication and it was useful for comparing postoperative morbidity between different centers.
· Xiaouha jiang MD et al8 of 2011,post-operative outcomes and complication after laproscopy assisted pylorus preserving gastrectomy for early gastric cancer done on 307 patients, concluded LAPPG is a safe operation with excellent postoperative outcomes in terms of minimized major complications based on clavien dindo classification.
· CK Oranusi, AME Nwofor et al9 on 2011: complication rates of open transvesical prostectomy according to clavein-dindo classification system:clavein-dindo classification provides excellent platform in an attempt to produce a veritable system under which complication rates following surgery can be compared.
· Jean J.M.CH de la rossete, dean opondo, francisco et al10 study conduted on 528 patients who underwent PCNL with complication created a set of 70 unique complication-management complied.concluded that the clavein score demonstrated highy validity for impact on PCNL complication on duration of stay and improved the reliabilty of of reporting adverse outcome on PCNL.
OBJECTIVES OF STUDY:
· To asses the clavein-dindo classification in grading and classifying the post surgical complications in abdominal surgery who admitted in KIMS surgical department.
· To validate the clavien score and categorise complications in each and individual procedures of elective major abdominal surgeries.
· Study on most common grade of complications in our hospital and its outcome.
7. MATERIALS AND METHODS
7.1 SOURCE OF DATA
All cases admited between DEC 2012 to JAN2014 under general surgical department for major elective abdominal surgeries were included in the study.
7.2 TYPE OF STUDY:
Prospective Time-Bound Hospital Based study.
INCLUSION CRITERIA:
All patients who admitted in general surgical department age more than 12 years who requires major abdominal surgeries were included
Major abdominal surgeries are
· Cholecystectomy, choledecholithotomy.
· Whipples procedure and other pancreatic surgeries.
· Gastrointestinal surgeries
· Transhiatal esophagectomy
· Spleenectomy
· Nephrectomy,Nephrolitomy and Uretrolithotomy.
EXCLUSION CRITERIA:
· Previously operated abdominal surgery.
· Pregnancy with surgical problems.
· Emergency abdominal surgeries.
· Complication developed after discharging from the hospital
7.3 METHOD OF COLLECTION OF DATA:
All abdomen cases admitted to surgical ward for major surgery will be evaluated through history, co-morbid condition and thorough clinical examination on the basis of inclusion and exclusion criteria. Routine investigation will be done and specific investigation like x-ray. USG and CT scan will do depending upon the provisional diagnosis and their requirement.and parameters like operative procedure, lenght of post-opeartive period, post operative complication and management recorded and then postsurgical complication classified based on clavien-dindo classification and assesed.
Classification of Surgical Complications by CLAVEIN-DINDO:
Grades / Definition
Grade I: / Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.
Acceptable therapeutic regimens are: drugs as antiemetics, antipyretics, analgeics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside
Grade II: / Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included
Grade III: / Requiring surgical, endoscopic or radiological intervention
Grade III-a: / Intervention not under general Anaesthesia
Grade III-b: / Intervention under general Anaesthesia
Grade IV: / Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management
Grade IV-a: / Single organ dysfunction (including dialysis)
Grade IV-b: / Multi organ dysfunction
Grade V: / Death of a patient
suffix D is added if patient had permanet disability at the time of discharge
7.4 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO DESCRIBE BRIEFLY.
Yes
· Complete blood picture.
· Random blood sugar, Blood urea, Serum creatinine.
· Serum electrolytes.
· Liver Function Test
· Chest x-ray.
· Ultrasonography
· CTabdomen if applicable.
· Any investigation done post-operative period if required.
o Post operative chest x-ray
o Post operative electrolytes
o Serum protein and albumin
· Period of follow-up
Followed up till discharge from the hospital, complication that will occure after discharge will not be included in the study.
· Statistical tests:
The collected data will be evaluated using appropriate statistical methods
7.5 HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.4?
Yes, ethical clearance has been obtained from the ethical committee of KIMS Hubli.
8.LIST OF REFERENCES:
1. Pierre-Alain clavein,MD,jaun and stevenberg: proposed classification of complication surgery with examples of utility in cholecyctectomy: Surgery may 1992:518-526
2. Daniel-dindo et al: Classification of surgical complication:newproposal with evaluation in cohort of 6336 patients and results of survey:Annals of surgery:vol240.agust 2004
3. Michelle L Deoliveira,MD et al :Assessment of Complications after Pancreatic surgery,A Novel grading system applied to 633 patients undergoing Pancreaticoduodenectomy.Annals of surgery:Volume 244,Number 6,December 2006:931-939.
4. B.Liu,L-N.Yan,j LI et al:using the clavein grading system to classify the complication of right hepatectomy in living donors: Transplantation proceedings 41,1703-1709:2009
5. Pierre A Clavein.MDet al: The Clavein-Dindo Classification of surgical complication: Annals of Surgery.vol 250 nov.2009187-195
6. AndrewJ.E, Seely MD et al study on systematic classification of morbidity and mortality after thoracic surgery: Annals Of Thoracic surgery vol 90- 2010:936-942.
7. Riccardo Casadei, Claudio Ricci et al: Assessment of the complication according to the clavein-dindo classification after distal pancreatectomy: journal of pancreas2011 mar9:12(2).
8. Xiaouha jiang MD et al:,post-operative outcomes and complication after laproscopy assisted pylorus preserving gastrectomy for early gastric cancer: Annals Of Surgery Vol253:5:May2011:928-933.
9. CK Oranusi, AME Nwofor : complication rates of open transvesical prostectomy according to clavein-dindo classification system: Nigerian Journal OF Clinical Practice:jan2012:vol15:issue1:34-37
10. Jean.J.M.CH De La Rossete et al: categorisation of complication and validation of the clavein scor for percutaneousnephrolithotomy: European Assocition urology vol:62(2012):246-255.
9 / Signature of candidate
10 / Remarks of guide
11 / Name and designation
11.1 Guide / DR. NARAYAN.I.HEBSUR M.S.
ASSOCIATE PROFESSOR ,
DEPT OF SURGERY,
KIMS, HUBLI.
11.2 Signature
11.3 Head of the department / DR.B.S MADAKATTI M.S
PROFESSOR,
DEPT OF GENERAL SURGERY,
KIMS, HUBLI.
11.4 Signature
12 / 12.1 Remarks of the Chairman and principal
12.2 Signature
FROM,
DR.B.N.HANUMATHAPPA
POST GRADUATE,
DEPARTMENT OF GENERAL SURGERY,
KIMS, HUBLI
TO,
THE PRINCIPAL
KIMS, HUBLI.
(THROUGH PROPER CHANNEL)
Respected sir,
Sub: Submission of proforma for registration of subject for Dissertation.
I am here with submitting my proforma for registration of dissertation titled “CLINICAL STUDY ON ASSESMENT OF POST SURGICAL COMPLICATIONS ACCORDING TO CLAVIEN DINDO CLASSIFICATION IN MAJOR ABDOMINAL SURGERY”
Kindly forward this to RGUHS, Bangalore.
Thanking you,
Yours sincerely,
DR. B.N HANUMANTHAPPA
Place: Hubli
Date:
KARNATAKA INSTITUTE OF MEDICAL SCIENCES
HUBLI – 580022
Ref No.
To,
The Registrar,
RGUHS,
Jayanagar, 4th block,
Bangalore-560011
Respected Sir,
Subject: Departmental Ethical clearance.
With regards to the subject mentioned above, the dissertation subject titled “CLINICAL STUDY ON ASSESMENT OF POST SURGICAL COMPLICATIONS ACCORDING TO CLAVIEN DINDO CLASSIFICATION IN MAJOR ABDOMINAL SURGERY” is justifiable and has taken ethical clearance from the department.
Thanking you,
Yours sincerely,
Dr. B. S. Madakatti
Professor & Head,
Dept. of Surgery
KIMS, Hubli
Date:
Place: Hubli
KARNATAKA INSTITUTE OF MEDICAL SCIENCES
HUBLI – 580022
Ref No.
To,
The Registrar,
RGUHS,
Jayanagar, 4th block,
Bangalore-560011
Respected Sir,
Subject: Institutional Ethical clearance.
With regards to the subject mentioned above, the dissertation subject titled “CLINICAL STUDY ON ASSESMENT OF POST SURGICAL COMPLICATIONS ACCORDING TO CLAVIEN DINDO CLASSIFICATION IN MAJOR ABDOMINAL SURGERY” is justifiable and has taken ethical clearance from the institution.
Thanking you,
Yours sincerely,
Principal,
KIMS, Hubli
Date:
Place:
15