Annexure- I rajiv gandhi university of health sciences bangalore proforma for registration of subjects for dissertation



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ANNEXURE- I

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1



Name of the Candidate

And Address :

DR. PINAKI MOHANTY,

DEPT. OF SURGERY,

MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL, DANDUPALYA, KOLATHUR

POST – HOSKOTE, BANGALORE – 562114.

2



Name of the Institution:

MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL,

DANDUPALYA, KOLATHUR POST

HOSKOTE, BANGALORE – 562114.



3



Course of study and subject:

M.S. GENERAL SURGERY


4



Date of admission and course:

31/05/2011 (Three Years)


5



Title of the Topic:


A CLINICAL STUDY AND GRADING OF PERIOPERATIVE COMPLICATIONS IN TRANSURETHRAL RESECTION OF THE PROSTATE.


6

Brief resume of the intended work:

6.1 Need for the study:
The reported incidence of the perioperative complications following transurethral resection of the prostate (TURP) varies considerably among different centers.
There was a lack of consensus on how to define complication & grade the perioperative in reporting the incidence of complications following TURP.
This has hampered proper interpretation of surgical outcome data for a long time.
The Modified Clavien Classification System (MCCS) has been proposed in 2004 as a standard tool to define complications and to grade the perioperative complications to assess the of treatment outcome. 
Our study is to evaluate the applicability of Modified Clavien Classification System to define and grade the of perioperative complications of TURP in the management of Benign Prostatic Hypertrophy (BPH) using Monopolar Electrosurgical System, to assess quality of treatment outcome.







    1. Review of literature:

The absence of a definition and a widely accepted ranking system to classify surgical complications has hampered proper interpretation of surgical outcome data for a long time. Though a number of attempts have been made in the 1990s to classify surgical complications, but none of them have gained widespread acceptance. In 1992, a novel approach1 was presented to rank complications by severity based on the therapy used to treat the complications, and differentiated 3 types of negative outcome after surgery, (a) complication, (b) failure to cure, and (c) sequela. Although this system was used by few investigators, they revisited this grading system in 2004, after its routine use for more than 12 years. They developed a new 5-scale classification system with the aim of presenting an objective, simple, reliable and reproducible way of reporting negative events after surgery2. They concluded that the Modified Clavien Classification System (MCCS) is reliable and may represent a compelling tool for quality assessment of surgery worldwide.



In a prospective study of 10,654 patients undergoing transurethral prostate resection by Reich O et al3, it was found that though the mortality rate is low (0.10%), the cumulative short – term morbidity rate was 11.1%.

Gupta NP, Doddamani DD and Kumar R in their study4 of 109 patients, found that TURP leads to a deterioration of sexual function in up to 33 % of patients, having pre operative normal sexually active life. This includes both loss of libido and erections. It also associated with a loss of antegrade ejaculation in over 8.5%. patients.

DeSilva WAS et al5 in 2008 studied over the complication rate of 321 patients who underwent TURP and found that it was to be 9.97%. They grouped those into Immediate, i.e. occurring within 24 hours (Intractable primary bleeding, Converted to open surgery and packing, Rediathermization before sending to ward, Postponement and TURP later, Blood transfusion, Large capsular perforation with intractable bleeding, ARF necessitating dialysis); Early, i.e. within 2 weeks (Failed TWOC recurring re–TURP, Transient incontinence, Secondary haemorrhage) and Late complications (Urethral stricture, Bladder neck contracture, Incontinence). Only one patient died who had a history of Ischemic Heart Disease (IHD) and died due to cardiogenic shock following acute myocardial infarction.

In another study, by Mamoulakis C et al6 in 2009 of evaluation for complications occurring up to the end of the first postoperative month of 198 patients with benign prostatic hyperplasia submitted to TURP using monopolar electrosurgical system, the complication rate is found to be 15.7%, which were classified prospectively according to the MCCS, they conclude that the MCCS is non–time–consuming, easily applicable tool for grading perioperative TURP complications. It may well serve as a straight forward, standardized platform allowing for sound comparisons, either longitudinally within centers to facilitate audit or among centers using similar or different technologies such as monopolar vs. bipolar TURP. It may serve as a standardized platform of communication among clinicians allowing for sound comparisons.








    1. Objectives of the study:

The objective of the study is to evaluate the applicability of the modified Clavien Classification System (MCCS) in defining and grading perioperative complications of transurethral resection of prostate to assess the incidence of complications and quality of treatment outcome, in our study group.

7



Materials and Methods:

7.1 Source of data:

Cases with signs and symptoms due to BPH, who are admitted in the surgical ward of MVJ Medical College and Research Hospital.


7.2 Method of collection of data (including sampling procedure if any):


  1. Definition of sample (case) of the study:

Patients with signs and symptoms of bladder outlet obstruction due to BPH, who are admitted in surgical ward of MVJ Medical College and Research Hospital, are subjected to undergo TURP using Monopolar Electrosurgical System & followed upto one month postoperatively. Data, collected as per the Proforma in 50 cases, is then to be analysed.




  1. The method of study consists of:




  1. Detailed history taking and a thorough physical examination as per the proforma.

  2. Recording the International Prostate Symptom Score (I–PSS) as per the International Proforma.

  3. Digital Rectal Examination (DRE) done to exclude Carcinoma of the Prostate. If any suspicion arises, then TRUS – directed prostate needle biopsy done to rule out Carcinoma of the Prostate.

  4. Blood for Complete Blood Count (CBC), along with other investigation (like BT/CT, Blood Grouping, FBS, RFT, Serum PSA, LFT, ECG, CxR) for the fitness for surgery.

  5. Abdominal Ultrasonography to confirm the diagnosis & assess the volume of the Prostate and Post void residual urine volume.

  6. All patients are subjected to undergo TURP using Monopolar Electrosurgical System.

  7. Identify the perioperative complication up to one month postoperatively and grade according to the Modified Clavien Classification System (MCCS).

  8. Compile all the data & compare our results with the results of reported literatures.




  1. Inclusion criteria:



a)All clinically diagnosed BPH patients with moderate to severe I-PSS and willing to undergo TURP are included in the study group.



  1. Exclusion criteria:



a)Patients diagnosed to have Carcinoma Prostate during work up or incidentally diagnosed to have Carcinoma Prostate after the procedure by Histopathology study are excluded.



b)BPH patients requiring additional procedures for associated clinical entities (eg. Vesical Calculus, Bladder Diverticula) are also excluded.



7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals?
Routine investigations will be conducted on the patients to assess fitness for anaesthesia and surgery as mentioned below. Only the standard surgical procedure (TURP) for treating BPH will be done. No investigations or interventions will be conducted on animals.


  • Complete Blood Count.

  • BT/CT & Blood Grouping.

  • Renal Function Test (RFT) assessed by Blood urea, S. creatinine and S. uric acid.

  • Liver Function Test (LFT) assessed by Serum Billirubin, SGOT, SGPT, Alk. Phosphatase, Total Protein and Albumin.

  • Serum Prostate Specific Antigen (PSA).

  • Urine Routine and Culture sensitivity Examination.

  • Electrocardiogram (ECG) & Chest X–Ray PA view.

  • Abdominal Ultrasonography to confirm the diagnosis & assess the volume of the Prostate and Post void residual urine volume.








7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes

8



List of references:


  1. Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992; 111(5): 518 – 526.

  2. Dindo D, Demartines N, Clavien PA. Classification of Surgical Complications: A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Annals of Surgery. 2004; 240 (2): 205 – 213.

  3. Reich O, Gratzke C, Bachmann A, Seitz M, Schlenker B, Hermanek P, Lack N, Stief CG; Urology Section of the Bavarian Working Group for Quality Assurance. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol. 2008 Jul; 180 (1): 246 – 249.

  4. Gupta NP, Doddamani DD, Kumar R. Sexual function status before and after transurethral resection of prostate (TURP) in Indian patients with benign hyperplasia of prostate. Indian Journal of Urology, 2004; 20 (2): 86 – 90.

  5. DeSilva WAS, Ranga KMGN, Karunaratne DMRPP, Sirisena KSC, Dissanayake DMAS. Surgical intervention in bladder outlet obstruction due to prostatic enlargement – A prospective study. Sri Lanka Journal of Urology. 2008; 9: 13 – 19.

  6. Mamoulakis C, Efthimiou I, Kazoulis S, Christoulakis I & Sofras F. The modified Clavien classification system: a standardized platform for reporting complications in transurethral resection of the prostate. World J Urol. 2011; 29: 205 – 210.



9



Signature of the candidate :


10



Remarks of the Guide

The reported incidence of perioperative complications following TURP varied considerably among published reports. This was attributed to lack of consensus on how to define and grade the severity of these complications.


The modified Clavien Classification System (MCCS) has been proposed as a standard tool to report these complications.
Therefore, this study is intended to evaluate the applicability of MCCS in the defining & grading the perioperative complications to assess the quality of treatment out come in our centre.


11



Name & Designation of (in block letters)


11.1 Guide

11.2 Signature

DR. R. VIJAYA KUMAR,

MS (GENERAL SURGERY),

PROFESSOR OF SURGERY,

DEPARTMENT OF GENERAL SURGERY,

MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL.







11.3 Co-Guide (if any)

11.4 Signature

NOT APPLICABLE

NOT APPLICABLE



11.5 Head of Department

11.6 Signature

DR. N. K. RAY,

MS (GENERAL SURGERY),

PROFESSOR & HEAD OF DEPARTMENT,

DEPARTMENT OF GENERAL SURGERY,

MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL.


12



12.1 Remarks of the chairman & principal

12.2 Signature






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