Rajiv Gandhi University Of Health Sciences, Karnataka
4th 'T' Block, Jayanagar, Bangalore-560 041
Proforma For Registration of Subject for Dissertation
1. Name of the candidate and address: Dr.ARJUN.N
13/559, KRISHNA GARDENIA APARTMENTS , RMV 2ND STAGE, DOLLARS COLONY, NEW BEL ROAD, BANGALORE- 56009
2. Name of the institution: M.S.RAMAIAH MEDICAL COLLEGE
3. Course of study and subject: M.S.GENERAL SURGERY
4. Date of admission to the course: 01/06/2012
5. Title of the topic: COMPARISON OF OUTCOME OF BIPOLAR TURP WITH MONOPOLAR TURP FOR BPH – A RANDOMIZED CONTROL STUDY
6. Brief resume of the intended work:
6.1) Need for the study:
Transurethral resection of prostate (TURP) is a standard operative procedure for patients with benign prostatic hypertrophy (BPH).
Irrigants used range from distilled water to a variety of solutions as glycine, saline, sorbitol and mannitol. Irrigant fluid absorption is a potentially serious complication of TURP, resulting in TURP syndrome with appreciable morbidity and mortality (1).Hence the ideal irrigant for endoscopic resections would be a non-ionizing medium that does not interfere with diathermy, has a high degree of translucency and only minimal side effects when absorbed.
The electrical ionizing properties of saline prohibits the use of conventional monopolar cautery but the development of bipolar resection systems now permit the use of normal saline as an irrigant. Use of bipolar cautery has been reported to be associated with less collateral and penetrative tissue damage, lower incidence of TURP syndrome and earlier hospital discharge. (2)
This study will be taken up to compare the safety and efficacy of bipolar cautery using saline as an irrigant with the conventional monopolar cautery systems using distilled water as an irrigant.
6.2) Review of literature:
Traditionally, TURP has been performed using monopolar technology with 1.5% glycine or mannitol as nonhemolytic fluids for irrigation, but concerns for TUR syndrome have led to introduction of bipolar TURP. According to the authors of Campbell – Walsh, Urology, the rationale for the introduction of bipolar TURP is that the complications of the standard monopolar TURP need to be reduced to improve acceptability by the patient.(3)
Transurethral resection of prostate is associated with procedural complications with TUR syndrome being the most noted. This is based on many factors with irrigant fluid used and resection time being the most important. In the study done by Piyush Singhania et al which compared monopolar versus bipolar resection of prostate gland showed the difference in the mean resected weight was 17.6 +/- 10.8 g in the monopolar group and 18.66 +/- 12.1 g in the bipolar group. Mean resection time was 56.76 +/- 14.51 min in the monopolar group and 55.1+/- 13.3 min in the bipolar group. The monopolar group showed a greater decline in serum sodium and osmolarity (4.12 meq/l and 5.14 mosmol/l) compared to the bipolar group (1.25 meq/l and 0.43 mosmol/l). The monopolar group however showed a statistically significant decline in Hb and PCV (0.97 g%, 2.83, p<0.005) as compared to the bipolar group (0.55g%, 1.62, p< 0.005). They hence concluded that bipolar transurethral resection of prostate though comparable clinically with monopolar resection, has an improved safety profile.(2)
In a similar study by Issa MM which concluded that since the risks of dilutional hyponatremia andtransurethralresection syndrome are eliminated, it allows for a longer and saferresection. (4)
Another study by Shiou-Shen Chen et al which monitored the hemolysis in patients undergoing monopolar transurethral resection of prostate, showed that there was significant hemolysis noted in 43.6 % of the patients immediately after operation. They concluded in patients with larger prostate volumes and with longer resection times, there are more chances of hemolysis while using monopolar resection methods.(5)
The above articles will be used in this study as an aid and to verify the results which will be obtained in the study done by us.
6.3) Objectives of the study :
· To compare the weight of the resected gland and resection time taken using bipolar cautery using saline as an irrigant with the conventional monopolar cautery systems using distilled water as an irrigant in TURP.
· To compare the incidence of TUR syndrome while using bipolar cautery with conventional monopolar cautery in TURP.
· To compare the fall in haemoglobin while using bipolar cautery with conventional monopolar cautery in TURP.
7) Materials and methods:
7.1) Source of data:
· STUDY DESIGN: Prospective randomized control study
· STUDY PERIOD: 2 years
7.2) Method of data collection:
1. Baseline information and a brief clinical history will be collected from all patients after a detailed informed consent. Uroflowmetry findings will be recorded, as well as patient age, weight and height. Preoperative blood investigations will include complete hemogram, renal function tests, chest X-ray and electrocardiogram. Preoperative International Prostate Symptom Score (IPSS) will be recorded. Both pre and post op serum sodium, potassium, osmolarity, hemoglobin and hematocrit values will be estimated.
2. TheInternational Prostate Symptom Score (IPSS)is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the diseaseBPH. The 7 symptoms questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency,weak stream, straining and nocturia, and each involving assignment of a score from 1 to 5 for a total of maximum 35 points.The 8th question ofquality of lifeis assigned a score of 1 to 6 and tabulated. 0-7 is mildly symptomatic, 8-19 is moderately symptomatic, 20-35 is severely symptomatic.(3)
3. The patients will be divided into two groups using standard randomization techniques. Group I will undergo TURP performed with monopolar cautery using 0.9% saline as an irrigant and Group II will undergo TURP performed by a bipolar cautery with distilled water as irrigant performed by the same surgeon under spinal anaesthesia.
4. Bipolar resection will be performed using the Autocon-2 400 bipolar resection system and monopolar resection will be performed using Erbee cautery using the Barnes method of resection in all the patients.
5. Post operatively, resection time, volume of irrigant used, weight of the resected gland and duration of surgery in both the groups will be recorded. The patients vital parameters (pulse, blood pressure, oxygen saturation monitoring by pulse oximeter) will be monitored and clinical signs of transurethral resection (TUR) syndrome will be analysed.
6. Patients will be followed up for a period of upto 6 months with an IPSS reassessment and uroflowmetry recording.
7. The results will be tabulated on a predesigned proforma.
INCLUSION CRITERIA:
· Failed medical therapy.
· Acute urinary retention with failed voiding trial.
· Recurrent urinary tract infection and hematuria.
EXCLUSION CRITERIA:
· Patients with documented or suspected prostate cancer, neurogenic bladder, previous prostate surgery, urethral stricture, associated bladder stones and renal impairment will be excluded from the study.
SAMPLE SELECTION AND SAMPLING PROCEDURES: Applying the inclusion and exclusion criteria, patients admitted under the department of Urology, M.S.Ramaiah Hospital during the period of the study will be taken up for the study. The subjects will be randomized to both groups by permuting the serial numbers of the patients employing random number tables.
STATISTICAL ANALYSIS WITH SAMPLE SIZE:
Rationale for sample size: The sample size of the present study has been estimated based on the study results of Piyush Singhania et al and Shiou-Sheng Chen et al, which have provided certain results regarding the mean resected weight by using both monopolar and bipolar resection using distilled water, saline and glycine as irrigant fluids .(2,5)
Sample size for the present study has been estimated based on the above findings with various types of comparisions considering the mean resected weight and haemoglobin as a parameter. The sample size for the present study was based on the mean resected weight of 17.6 +/- 10.8 g with the monopolar method and 18.66 +/- 12.1 g with the bipolar method with an alpha error of 10 % and power of the study at 80% and was worked out to be 62 patients in each group. With the other combinations considering similar modalities of surgical intervention also revealed 62 patients in each group should be sufficient to detect a statistical significance in the mean resected weight of prostate gland. Hence a total of 124 patients will be included in this study.
SAMPLE SIZE: 124 patients.
STATISTICAL ANALYSIS OF DATA: All the quantitative parameters such as operated time, resected weight of prostate gland, haemoglobin etc in each of the groups (bipolar method and monopolar method), will be summarized in terms of mean standard deviation. Differences in the outcome indicators such as mean resected weight between both the groups will be tested for statistical significance through t- test/appropriate non parametric tests of significance.
OUTCOMES AND IMPLICATIONS:
· To determine the safety profile and efficiency of bipolar TURP when compared to monopolar TURP.
· To determine if bipolar saline TURP may prove safer in patients with large prostates where longer resection time and greater absorption of irrigating fluid is a concern.
7.3) Does the study require any investigations or interventions to be conducted on patients or other humans or animals?
NIL.
7.4) Has ethical clearance been obtained from your institution ?
YES
8) References:
1. Gravenstein D, Transurethral resection of the prostate (TURP) syndrome: a review of the pathophysiology and management. Anesth Analg 1997; 84: 438-46.
2. Piyush Singhania, Dave Nandini, Fernandes sarita, Pathak hemant, Iyer hemalatha, Transurethral resection of prostate: A comparision of standard monopolar vs bipolar saline resection. Int Braz J Urol. 2010 Mar-Apr; 36(2):183-189
3. Wein.A,Kavoussi.L,Novick.A,Partin.A,Peters.C, editors, Campbell Walsh Urology – 10th edition
4. Issa MM, Technological advances in transurethral resection of the prostate: bipolar versus monopolar TURP. J Endourol. 2008; 22: 1587-95.
5. Shiou-Sheng Chen, Alex Tong-Long Lin, Kuang Kuo Chen, Luke S Chang, Hemolysis in transurethral resection of the prostate using distilled water as the irrigant. J Chin Med Assoc.2006 Jun; 69(6):270-5.
6. Martis G, Cardi A, Massimo D, Ombres M, Mastrangeli B, Transurethral resection of prostate: technical progress and clinical experience using the bipolar Gyrus plasmakinetic tissue management system. Surg Endosc. 2008; 22: 2078-83.
7. Ho HS, Cheng CW, Bipolar transurethral resection of prostate: a new reference standard? Curr Opin Urol. 2008; 18: 50-5.
8. Singh H, Desai MR, Shrivastav P, Vani K, Bipolar versus monopolar transurethral resection of prostate: randomized controlled study. J Endourol. 2005; 19: 333-8.
1. Signature of the candidate:
2. Remarks of the guide:
3. Guide name and Designation: Dr.S.V.Kulkarni
Professor and Head of Unit,
Department of General Surgery
4. Signature:
5. Co-guide name and designation: Dr.Ramesh
Professor and Head of Department, Deapartment of Urology
6. Signature:
7. Head of the department: Dr.S.V.Kulkarni
Professor and Head of Department,
Department of General Surgery
8. Signature:
9. Dean of the institution : Dr.Saraswathi.G.Rao
Principal and dean,
M.S.Ramaih Medical College
10. Signature:
11. Remarks of the dean: