Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka s5

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

SYNOPSIS

OF

DISSERTATION

"A COMPARATIVE STUDY OF OPEN PROSTATECTOMY AND TRANSURETHRAL RESECTION OF PROSTATE IN BENIGN PROSTATIC HYPERPLASIA"

Submitted by

Dr. ANAND KUMAR S.V.

M.B.B.S.

POST GRADUATE STUDENT IN

GENERAL SURGERY (M.S.)

DEPARTMENT OF GENERAL SURGERY

ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,

B.G.NAGARA-571448


RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / NAME OF THE CANDIDATE
AND ADDRESS
(in block letters) / Dr. ANAND KUMAR. S.V.
P.G. IN GENERAL SURGERY,
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G. NAGARA,
MANDYA DISTRICT -571448
2. / NAME OF THE INSTITUTION /

ADICHUNCHANAGIRI INSTITUTE OF

MEDICAL SCIENCES, B.G.NAGARA.
3. / COURSE OF STUDY AND SUBJECT /

M.S. IN GENERAL SURGERY

4. / DATE OF ADMISSION TO COURSE / 1ST JUNE 2009
5. / TITLE OF THE TOPIC / "A COMPARATIVE STUDY OF OPEN PROSTATECTOMY AND TRANSURETHRAL RESECTION OF PROSTATE IN BENIGN PROSTATIC HYPERPLASIA"
6. / BRIEF RESUME OF INTENDED WORK
6.1  NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX-I
APPENDIX-IA
APPENDIX-IB
APPENDIX-IC
7 / MATERIALS AND METHODS
7.1  SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 / APPENDIX-II
APPENDIX-IIA
APPENDIX-IIB
YES
APPENDIX-IIC

YES

8. / LIST OF REFERENCES /

APPENDIX - III

9. / SIGNATURE OF THE CANDIDATE /
10. /

REMARKS OF THE GUIDE

/ The study is currently important as benign prostatic hyperplasia is the commonest cause of obstructive uropathy, lower urinary tract symptoms (LUTS) or voiding dysfunction. Various modes of therapy are available for the same.
Open surgical prostatectomy is the common approach for large prostates>100g.
An advanced technology like transurethral resection of prostate (TURP) has been made available in AIMS, BG Nagar, Nagamangala Taluk.
Hence, a comparative study of the outcome of open surgical prostatectomy and that of a less/minimal invasive transurethral resection has been recommended.
11 / NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE / Dr. S.R.MAHIMANJAN SINGH M.B.B.S., M.S.
Professor,
Department of General Surgery,
AIMS, B.G. Nagara-571448
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY) / Dr. B.K. HANUMANTHA RAJU
M.B.B.S., M.S., D.N.B. (URO)
Associate Professor,
Department of General Surgery,
AIMS, B.G. Nagara-571448
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT / Dr. B.J. SREEKANTAIAH,
B.Sc, M.B.B.S., M.S., FICS
Professor and Head
Department of General Surgery,
AIMS, B.G. Nagara-571448
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
12.2 SIGNATURE


APPENDIX-I

6.BRIEF RESUME OF THE INTENDED WORK:

APPENDIX –I A

6.1 NEED FOR THE STUDY:

Prostate gland, in its diseased state, is one of the main etiological factors for obstructive uropathy1.

BPH occurs in men over 50years of age. By 60 years of age 50% of men have histological evidence of BPH.

By the age of 70 years most men suffer from outflow obstruction due to BPH 2.

This enlargement of prostate takes place uniformly in the transitional zone 3.

Surgery for BPH can be done either by open method or by transurethral resection or by laser.

All procedures have their own advantages, disadvantages and complications.

To date, the influence of minimally invasive surgery(MIS)on the open surgeons has not been comprehensively assessed.MIS may give major competition to the open technique and it has influenced open surgeons to modify their surgical technique, reduce convalescence and alter follow-up recommendations4.

Hence, there is a need to select the cases for particular procedure by considering clinical parameters like age of the patient, size of prostate, symptomatology and intercurrent diseases and to compare between the results of the two procedures.

APPENDIX –I B

6.2 REVIEW OF LITERATURE

·  This study undertakes to review the recent developments in the management of benign prostatic hyperplasia (BPH).

·  The treatment options for bladder outflow obstruction (BOO) caused by BPH have expanded dramatically over the past two decades.

·  Surgery for BPH has been attempted for over 2000 years.

·  In recent history, Young showed the perineal approach, which is not in use now.

·  Eugene Fuller did the first transvesical prostatectomy in 1894. (Open prostatectomy-non-perineal and subcapsular). It was also done by McGill about the same time.The procedure involved opening the bladder and digital enucleation of prostate.

·  Peter Freyer also demonstrated the suprapubic transvesical approach.

·  The retropubic prostatectomy was developed in 1945 by Terence Millin at the All Saints Hospital in London.

·  Transurethral resection of prostate (TURP) was developed in the US in the 1920s and 1930s.

·  In 1908, vacuum tube was invented by DeForest, which allowed the constant production of high-frequency electrical current (energy source) that could be used in resecting tissue5.

·  In 1926, Bumpus combined the cystoscope and the tubular punch. Also, Stearns developed the tungsten loop, that could be used for the resection.

·  This was put together by McCarthy in 1932, using a foroblique lens so that he could resect the tissue under direct vision using a wire loop.

·  In the 1970s, the development of the fiberoptic lighting system, together with the Hopkins (1976) rod lens wide-angle system, significantly improved visualization for endoscopic surgery.

·  Previously, the optical system was a series of small lenses placed in a rigid tube.

In the Hopkins rod lens wide angle system, the air spaces were replaced by solid glass rods. The spacer tubes were shorter, resulting in minimal obstruction and increased admission of light5.

·  Transurethral resectoscope : the instrument assembled has:

1.  Continuous flow/standard sheath.

2.  Working element with cutting loop.

3.  Telescope. 6

·  The standard monopolar TURP is now being replaced by the use of bipolar resection- the Gyrus plasmakinetic system. It has:

1.  Generator with 200W capability.

2.  Radiofrequency range of 320-450 kHz

3.  A voltage range of 254 to 350 V.

·  The experiences of a General Surgical unit in Singapore are: about 80% of BPH cases can be dealt with by TURP. The very large adenomas, however, are better removed by the open operations. A transurethral resectionist in a general surgical unit can therefore complement the work of the unit7.

·  Longer hospital stay and more resource implications were observed in the group of 6 patients (8.4% in the study) who underwent open surgical treatment8.

·  Despite the morbidity of open enucleation being substantial, until recently, no other options (than open prostatectomy) were available when the size of the prostate approached 100g and beyond9.

·  Compared to non-obese, obese men suffer more frequently from post-retropubic prostatectomy urinary incontinence and vesicourethral strictures following open surgery10.

·  The results of a study showed that urethral catheter traction diminishes bleeding compared with suturing at the prostatic vesical junction during suprapubic prostatectomy11.

·  Transurethral resection was superior to open resection for prostates weighing 20g-100g. Also, the blood loss, need for transfusion, amount of blood transfused and the duration of surgery, catheterization and hospital stay were all related to prostate size12.

·  In the absence of comorbid conditions, i.e., a healthy subset of patients, there was no significant survival difference between the two procedures-open and TURP13.

·  Open prostatectomy should be considered when:

1.  Bladder diverticulectomy is to be done concurrently, if diverticula are sizeable.

2.  Large bladder calculi, not easily fragmentable.

3.  Ankylosis of hip which prevents proper positioning for TURP.

  1. In men with urethral stricture or previous hypospadias repair, to avoid the urethral trauma associated with TURP.
  2. Association of an inguinal hernia with an enlarged prostate-open method preferred as the hernia may be repaired through the same lower abdominal incision. (Schlegel and Walsh, 1987)

·  Contraindications to open prostatectomy include:

1.  A small fibrous gland.

2.  Previous prostatectomy or pelvic surgery that may obliterate access to the prostate gland14.

APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY

1.  To study the surgical management of BPH with emphasis on open prostatectomy and TURP.

2.  To compare the outcomes of open prostatectomy and TURP in BPH.

3.  To assess morbidity, mortality and complications associated with prostatectomy with respect to case specific BPH.

APPENDIX-II

7.0 MATERIALS AND METHODS

Sample size : Total of 50 consecutive cases.

1.  30 cases of BPH for TURP.

2.  20 cases of BPH for open prostatectomy

APPENDIX-II A

7.1 SOURCE OF DATA

All the cases of BPH admitted and treated in AIMS, BG Nagar, between December 2009 and June 2011 (18 months duration), by either open method or TURP will be chosen to be a part of this study.

APPENDIX-II B

7.2 METHOD OF COLLECTION OF DATA

·  Abdominal/external genitalia examination, and digital rectal examination (DRE)

·  Investigations-radiological, histopathological, biochemical and microbiological.

·  Collection of data pertaining to post-operative complications, morbidity and mortality

INCLUSION CRITERIA

1.  Patients with clinical features of BOO due to BPH.

2.  Patients with moderate symptoms with failed medical management.

3.  Significant post-void residual urine.

4.  Renal insufficiency and hydronephrosis due to BPH.

5.  Patients with acute urinary retention.

6.  Recurrent gross haematuria of prostatic origin.

EXCLUSION CRITERIA

1.  Patients who are medically unfit for surgery.

2.  Patients who request medical management and decline surgical treatment.

3.  Patients with symptoms of BOO due to causes other than BPH.

4.  Patients with BPH responding well to medical line of management.

APPENDIX-II C

7.3 Does the study require any investigation or intervention to be conducted on the patients or animals , if so please describe briefly

YES

1.  Urinalysis (with urine microscopy)

2.  Culture for bacteria and antibiotic sensitivity.

3.  Blood urea nitrogen (BUN) levels and serum creatinine.

4.  Blood examination.

5.  PSA levels.

6.  Radiology:

a.  Plain X-ray KUB

b.  Chest X-ray

c.  IVU

d.  USG - Transabdominal

- Transrectal

- Transurethral

7.  CT scan and MRI.

8.  Prostate biopsy.

9.  Multichannel urodynamic studies-uroflowmetry and cystometry.

10.  Cystoscopy.


APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A
a / Title of the study / " A COMPARATIVE STUDY OF OPEN PROSTATECTOMY AND TRANSURETHRAL RESECTION OF PROSTATE IN BENIGN PROSTATIC HYPERPLASIA "
b / Principle investigator
(Name and Designation) / Dr. ANAND KUMAR. S.V.
P.G IN GENERAL SURGERY,
ADICHUNCHUNAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
c / Co-investigator
(Name and Designation) / Dr. S.R.MAHIMANJAN SINGH M.B.B.S., M.S.
Professor
Department of General Surgery,
AIMS, B.G. Nagara-571448
d / Name of the Collaborating
Department/Institutions / NA
e / Whether permission has been obtained from the heads of the collaborating departments & Institution / YES
Section – B
Summary of the Project / APPENDIX I
Section – C
Objectives of the study
Section – D
Methodology
A / Where the proposed study will be undertaken / DEPARTMENT OF UROLOGY, BIOCHEMISTRY, MICROBIOLOGY, PATHOLOGY AND RADIOLOGY
B / Duration of the Project /
18 MONTHS
C / Nature of the subjects:
Does the study involve adult patients?
Does the study involve Children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant women? / YES
NO
NO
NO
NO
D / If the study involves health volunteers
I.  Will they be institute students?
II.  Will they be institute employees?
III.  Will they be Paid?
IV.  If they are to be paid, how much per session? / NO
NO
NO
NA
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trial been approved by the ethics Committee of the other centers?
If the study involves the use of drugs please indicate whether.
I. The drug is marketed in India for the indication in which it will be used in the study.
II. The drug is marketed in India but not for the indication in which it will be used in the study
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of India has been obtained for:
  Use of the drug in healthy volunteers
  Use of the drug in-patients for a new indication.
  Phase one and two clinical trials
  Experimental use in-patients and healthy volunteers. / NA
NA
NA
NA
NA
NA
NA
NA
G / How do you propose to obtain the drug to be used in the study?
-  Gift from a drug company
-  Hospital supplies
-  Patients will be asked to purchase
-  Other sources (Explain) / NA
H / Funding (If any) for the project please state
-  None
-  Amount
-  Source
-  To whom payable / NIL
I / Does any agency have a vested interest in the out come of the Project? / NO
J / Will data relating to subjects /controls be stored in a computer? / NO
K / Will the data analysis be done by
-  The researcher?
-  The funding agent / YES
NO
L / Will technical / nursing help be required form the staff of hospital.
If yes, will it interfere with their duties?
Will you recruit other staff for the duration of the study?
If Yes give details of
I.  Designation
II.  Qualification
III.  Number
IV.  Duration of Employment / YES,
but it will not interfere with their duties
NO
NO
M / Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent? Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give reason: / YES
YES
NO
YES
NO (CHILDREN OR MINORS NOT INVOLVED IN THE STUDY)
N / Describe design, Methodology and techniques / APPENDIX II

Ethical clearance has been accorded.

Chairman,

P.G Training Cum-Research Institute,

A.I.M.S., B.G.Nagara.

Date :

PS : NA – Not Applicable


APPENDIX-III

8. LIST OF REFERENCES

1.  Claus G.Roehrborn,MD and John D McConnell,MD, Ch.86-BPH:etiology,pathophysiology, epidemiology and natural history; in pg. 2727, vol.3,Campbell-Walsh Urology, 9th ed., by Saunders-Elsevier, 2007. Editors: Wein, Kavoussi, Novick, Partin, Peters

2.  David Neal, Ch.73-Prostate and seminal vesicles, pg.1345, Bailey and Love’s - short practice of surgery, 25th ed., 2008, Hodder-Arnold, editors: NS Williams, CJK Bulstrode and PR O’Connell.