ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
NAME OF THE CANDIDATE & ADDRESS
DR. PRIYADARHINI C.A
POST GRADUATE IN GENERAL SURGERY
NAME OF THE INSTITUTION
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,
COURSE OF STUDY AND SUBJECT
M.S. (GENERAL SURGERY)
DATE OF ADMISSION TO THE COURSE
TITLE OF TOPIC
SURGICAL MANAGEMENT OF BENIGN PROSTATIC HYPERPLASIA
BRIEF RESUME OF INTENDED WORK:
6.1 Need for study:
Benign prostatic hyperplasia (BPH) is a histological diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone [Lee et al. 1997, 1995]. The enlarged gland is thought to lead to disease manifestations via two routes: (1) the static component: direct bladder outlet obstruction (BOO) from enlarged tissue; and (2) the dynamic component: from increased smooth muscle tone and resistance within the enlarged gland. Therapy for BPH typically targets one or both of the disease components (static or dynamic) to provide relief. Surgical intervention is an appropriate treatment alternative for patients with moderate-to-severe lower urinary tract symptoms (LUTS) and for patients who have developed acute urinary retention (AUR) or other BPH-related complications. In addition, medical therapy may not be viewed as a requirement because some patients may wish to pursue the most effective therapy as a primary treatment if their symptoms are particularly bothersome.
The 2003 AUA Guideline recognized that transurethral resection of prostate (TURP) remained the benchmark for therapy as it permits a high success rate in symptom scores, urinary flow, postvoid residue and low retreatment rate on long-term follow up4. However, multiple complications can be observed after TURP: perioperative bleeding, blood transfusions, transurethral resection (TUR) syndrome, prolonged catheterization, long hospital stay, urinary incontinence, and retrograde ejaculation are the most important. In an effort to keep the same efficacy of TURP while reducing the related complications, various surgical techniques have been developed in recent years. Various laser and electrovaporization prostatectomy techniques have been gaining popularity in recent years by reducing the two most important morbidities noted with TURP; namely, hemorrhage and electrolyte disturbance due to excessive irrigation fluid absorption. Transurethral vaporization resection of the prostate is one of the more recent modifications to standard TURP.
In 1999 TURP represented the 81% surgical treatment for BPH versus 39% of 20051, and the future will show if this is a marketing driven change or if there is a real advantage in new technologies. In the present paper we review the surgical treatment options currently available for BPH and the efficacy and safety of open prostatectomy and transurethral vaporization of prostate with the standard transurethral resection of prostate.
6.2 Review of Literature
1) Benign Prostatic Hyperplasia: The evaluation of impact of surgical treatment with Open Prostatectomy and Transurethral Resection of Prostate on the quality of life. Snjezana Milicevic, Predrag Grubor, Nenad Lucic
Benign prostatic hyperplasia is one of the most common diseases in older men. The objective of this study was to evaluate the impact of the surgical treatment of the benign prostatic hyperplasia (BPH) with the methods of open prostatectomy (OP) and transurethral resection of the prostate (TURP) on the quality of life. The research material was based on 80 patients, out of whom 40 patients were treated with the method of open prostatectomy (Group A), and the other 40 patients with the method of transurethral resection of prostate gland (Group B) due to benign prostatic hyperplasia. All patients were under the age of
80 years old with the International Prostate Symptom Score (IPSS) value >19 points, postvoid residual urine higher than 150 ml, the weight of benign prostatic gland hyperplasia tissue over 30 grams for method of prostate transurethral resection, and over 80 grams for the method of open prostatectomy. The quantification of the quality of life, as a consequence of urinary symptoms, was done by the Quality of Life Index (QLI) which is question Nº 8 in IPSS. All patients were determined the value of this score before the operation, and then in postoperative period in time intervals of 4.8 and 12 weeks. By testing the difference of the QLI arithmetic mean between the patients in both groups A and B, preoperatively there was no statistically significant difference, but during all postoperative checkups, there was a highly statistically significant difference between the test values. It was found that the surgical treatment of BPH leads to significant improvement of the quality of life, as a consequence of urinary symptoms. The improvement of the quality of life was more evident in patients whose BPH was treated with the OP method.
2) Recent advances in the surgical treatment of benign prostatic hyperplasia. Bernardo Rocco et al.
TURP for many years has been considered the gold standard for surgical treatment of BPH. Symptoms relief, improvement in Maximum flow rate and reduction of post void residual urine have been reported in several experiences. Notwithstanding a satisfactory efficacy, concerns have been reported in terms of safety outcomes:intracapsular perforation, TUR syndrome, bleeding with a higher risk of transfusion particularly in larger prostates have been extensivelyreported in the literature. In the recent years the use of new forms of energy and devices such as bipolar resector, Ho: YAG and potassium-titanyl-phosphate laserare challenging the role of traditional TURP for BPH surgical treatment. The guidelines and higher evidence studies were analysed to evaluate the role of the most relevant new surgical approaches compared to TURP for the treatment of BPH. In case of prostates of very large size the challenge is ongoing, withminimally invasive laparoscopic approach and most recently robotic approach.
3) Evaluation of TURP versus Contact laser vaporization for benign prostatic enlargement. S.R. Keoghane et al.
The objective of this study was to evaluate the effect of contact laser prostate surgery in the treatment of benign prostatic hyperplasia. A prospective double-blind randomized controlled trial of transurethral resection of the prostate (TURP) and contact laser prostatectomy was conducted, with an economic evaluation of both procedures. The primary outcome measure was the change in the American Urologic Association symptom score, with secondary outcome measures being the peak urinary flow rate, treatment-related complications, re-operation rate and health service costs. There was no clinically significant difference between TURP and contact laser prostatectomy in the mean change in symptom scores and flow rates. However there were distinct perioperative advantages in favour of the contact laser treatment, but some disadvantages in terms of re-catheterization and re-operation rates. Contact laser prostatectomy is a valid treatment for benign prostatic hypertrophy.
4) Trend in surgical management of BPH and laser therapy in the past three years. Pierre-Alain Hueber, Kevin C. Zorn
In many developing countries with an aging population, BPH associated with LUTS has become a major health issue. To optimize quality of care and control of cost, there is an imperative need to examine the pattern of BPH management. The number of TURP procedures performed were collected. Overall, the total number of TURP procedures remained stable. In contrast, the number of alternative minimally invasive procedures
has slowly grown. The use of minimally invasive laser procedure alternatives to TURP is progressively growing. Among the novel laser therapies, HoLEP and GreenLight vaporization are the only procedures that have demonstrated equivalent outcomes compared
to TURP in randomized clinical trials.
5) Comparison of 2-micro m Continuous Wave Laser Vaporesection of the Prostate and TURP Wei J. Fu et al.
The study was done to compare the safety and efficacy of the 2-micro m continuous wave (cw) laser vaporesection of the prostate with TURP in patients with symptomatic BPH. Efficacy follow-up included measurement of International Prostate Symptom Score, quality of life score, maximal urinary flow rate, and postvoid residual volume. The mean operative time was slightly longer in the 2-micro m laser group. Catheter indwelling time and hospitalization time were shorter in the 2-microm group and peri-operative morbidity was less than in the TURP group. The 2-microm cw laser vaporesection is a novel technology with favorable perioperative safety as well as the same therapeutic effect as TURP, and has the advantage of significantly less blood loss, shorter hospitalization, and shorter catheter indwelling time.
6) Feasibility of open simple prostatectomy with early vascular control A. Shaheen and D. Quinlan
This study determined the feasibility of open simple prostatectomy with early vascular control in the treatment of benign prostate hyperplasia (BPH), and thus reduce blood loss. 37 patients were reviewed and the mean operative duration was 1.3 h and the mean blood loss 841 mL, with a mean decrease in haemoglobin level of 22 g/L. Six (16%) of the patients received a blood transfusion. There was one (3%) death and one case of pulmonary embolism. Three patients (8%) developed stress incontinence. Two failed to
void after surgery and one developed acute retention 3 years later. Five patients
developed recurrent obstructive symptoms. Thus Open simple prostatectomy with early vascular control reduces the amount of blood loss, rendering it a safe option for treating BPH.
7) Managing benign prostatic hyperplasia: Medical and Surgical treatment. Pamella Dull, Robert W. Reagan, Robert R. Bahnson
Medical and surgical options for the treatment of benign prostatic hyperplasia have expanded in recent years. Nonselective alpha blockers provide rapid relief of symptoms and are relatively inexpensive, but they can cause dizziness and orthostatic hypotension which occur less often with tamsulosin, a more selective alpha blocker. Finasteride, a 5 alpha reductase inhibitor, slowly reduces prostatic volume but is not as effective as alpha blockers, especially in men with a smaller prostate. Dutasteride, a new 5_-reductase inhibitor, has recently been labeled for the treatment of BPH. Surgery may be appropriate initial treatment
in patients with severe symptoms who are not at high risk for complications. Surgery may
also be indicated in patients who have failed medical therapy or have recurrent infection,
hematuria, or renal insufficiency. Transurethral resection of the prostate is effective in most
patients, but it carries some risk of sexual dysfunction, incontinence, and bleeding. Surgical
procedures that use thermal microwave or laser energy to reduce hyperplastic prostate
tissue have recently become available. In general, the newer procedures are less expensive
than transurethral resection of the prostate and have fewer complications; however, the
need for retreatment is somewhat greater with these less invasive techniques.
8) Functional outcomes and complications following transurethral procedures for LUTS resulting from BPH Sascha A. Ahyai et al.
There is a continuous decline in the number of transurethral resections of the prostate and an increase use of minimally invasive surgical therapy (MIST) for lower urinary tract symptoms resulting from benign prostatic enlargement. Current results from randomised controlled trials (RCT) and methodologically sound prospective studies suggest
that some of the proposed procedures have the potential to replace TURP. To determine the contemporary status of TURP and of the currently most commonly applied transurethral MISTs: (1) bipolar TURP, (2) bipolar transurethral vaporisation of the prostate (bipolar TUVP), (3) holmium laser enucleation of the prostate (HoLEP), and (4) potassium-titanyl-phosphate (KTP) laser vaporisation of the prostate. This meta-analysis was based on a systematic Medline search assessing the period 1997–2009. It demonstrates statistically comparable efficacy and overall morbidity for MISTs versus contemporary TURP. Type, category (minor vs major), and the number of complications (safety profile) vary specifically for each of the different transurethral techniques. The individual patient’s clinical profile should be carefully assessed to identify the most appropriate transurethral technique.
9) Photoselective vaporization of Prostate Alexander Bachmann et al.
This study aimed to investigate safety and efficacy of 80 watt high-power potassium titanyl phosphate (KTP) laser vaporization of the prostate in men with lower urinary tract symptoms (LUTS) secondary to BPH. 108 patients underwent 80W KTP laser vaporization. Functional follow-up included measurement of maximum urinary flow rate (Qmax), postvoid residual volume (Vres) and International Prostate Symptom Score (IPSS) within a 12 months period. Qmax increased highly significantly. Correspondingly, Vres, IPSS and Bother Score improved to an extent that was statistically highly significant (p < 0.001) immediately after surgery. The observed complication rate within one year was low. Thus 80 W KTP laser vaporization is a virtually bloodless, safe and effective procedure for surgical treatment of LUTS secondary to BPH. A significant improvement of objective and subjective voiding parameters was observed just after surgery. KTP laser vaporization is associated with a low rate of complications.
10) Comparison of standard transurethral resection, transurethral vapour resection and Holmium laser enucleation of the prostate for managing Benign Prostatic Hyperplasia
Narmada Gupta, Sivaramakrishna, Rajeev Kumar, Prem N. Dogra and Amlesh Seth
All India Institute of Medical Sciences, Department of Urology, New Delhi, India
This study was done to compare the safety and efficacy of two alternatives for surgically treating symptomatic benign prostatic hyperplasia (BPH), i.e. transurethral vapour resection of the prostate (TUVRP) and holmium laser enucleation of the prostate (HOLEP), with transurethral resection of the prostate (TURP), the standard surgical therapy, as treating large prostates is associated with greater morbidity. 150 patients (50 in each group) with BPH and glands of > 40 g were prospectively randomised to undergo either TURP, TUVRP or HOLEP. The evaluation before treatment included urine culture, serum prostate specific antigen (PSA) level estimation, the International Prostate Symptom Score (IPSS), peak urinary flow rate (Q max), and transabdominal ultrasonography to estimate prostate size and postvoid urine residue (PVR). The operative duration, blood loss, resected tissue weight, change in levels of haemoglobin and serum sodium, nursing contact time, duration of catheterization, and complications were noted. After surgery patients were reassessed for the IPSS, Q max and PVR at 6 months and 1 year. The mean operating duration and intraoperative irrigant used for TUVRP was less than for HOLEP or TURP, and blood loss
with HOLEP and TUVRP was less than with TURP (all P < 0.001). Postoperative irrigation, nursing contact time, and catheter duration were significantly less for HOLEP than TURP or
improvement from baseline in IPSS, Q max, and PVR, but the differences between the groups were not significant at 6 months or 1 year. It was seen that HOLEP and TUVRP are both acceptable alternatives to TURP for treating large prostate glands, with less perioperativemorbidity and comparable efficacy at 6 months and 1 year.
11) Benign Prostatic Hyperplasia: A study of transurethral vaporisation resection of prostate using the thick loop and standard transurethral prostatectomy.
Riyadh F. Talic et al.
Transurethral vaporization resection of the prostate (TUVRP) uses one of the novel, thick resection loops coupled to augmented electrocutting energy. This study evaluated the safety and efficacy of TUVRP in comparison with TURP. 68 patients with prostatic outflow obstruction were prospectively randomized between equal TUVRP and TURP treatment groups. Safety parameters evaluated included changes in serum hemoglobin, hematocrit, and sodium 1 and 24 hours after resection. Operative time, catheterization time, and incidence of complications were noted. Efficacy parameters included evaluation by the International Prostate Symptom Score and maximum flow rate. Patients of both groups were balanced for the different baseline variables. One hour after TURP, patients had significantly lower levels of hemoglobin, hematocrit, and sodium. The prostate resection weight was similar in both groups; however, the difference in the mean operative time was significant (TUVRP group 42.4 minutes and TURP group 35.9 minutes, P 5 0.02). The postoperative catheterization time was significantly shorter for the TUVRP group. All patients were followed up for an average of 9 months. The International Prostate Symptom Score was 4 6 3.4 and 5.6 6 3.1 and the maximum flow rate was 19 6 6.5 and 15.2 6 10 mL/s for the TUVRP and TURP groups, respectively; these differences were statistically significant (P 5 0.03 and 0.01, respectively). Complications included urethral strictures and delayed hemorrhage with clot retention; no differences in the incidence of complications were noted between the two group. The results of the study have demonstrated that TUVRP is as safe and efficacious as TURP in the treatment of men with prostatic outflow obstruction. The shorter catheterization time observed after TUVRP may be clinically significant, considering the demand for lower morbidity profiles by patients.
The longer operative time in TUVRP was related to the slower motion of the Wing electrode needed to add the advantages of electrovaporization.
6.3 Objectives of study:
To study the surgical management of BPH with emphasis on open prostatectomy, transurethral resection and transurethral vapourisation of prostate.
To compare the outcomes of open prostatectomy, TURP and TUVP in benign prostatic hyperplasia and to assess the morbidity, mortality and complications associated with them.
MATERIALS AND METHODS:
7.1 Source of data:
All patients with benign prostatic hyperplasia admitted and treated in KIMS, Hubli by either open prostatectomy, transurethral resection or transurethral vaporization of prostate will be chosen to be a part of the study.
7.2 Type of the study:
A prospective hospital based time bound observational study between December 2013 and December 2014 to study the efficacy and safety of the various modalities of surgical management in patients with benign prostatic hyperplasia.
Sample size: 60 patients
All patients with the following findings:
Patients with clinical features of bladder outlet obstruction due to BPH.
Patients with moderate to severe symptoms with failed medical management.
Renal insufficiency and hydronephrosis due to BPH.
Patients with recurrent urinary retention.
Recurrent gross haematuria of prostatic origin.
Patients with vesical calculus.
Patients with recurrent urinary tract infections.
Patients who are medically unfit for surgery.
Patients who request medical management and decline surgical treatment.
Patients with symptoms of BOO due to causes other than BPH.
Patients with BPH responding well to medical line of management.
Methods of collection of data:
Clinical history, clinical examination and digital rectal examination (DRE)
Investigations-radiological, histopathological, biochemical and microbiological.
Collection of data pertaining to post-operative complications, morbidity and mortality
Does the study require any investigation to be conducted on patients or animals specify. “ Yes”
The following investigations will be done in all cases
Random blood sugar
Renal function tests
Urinanalysis (with urine microscopy)
Serum PSA levels
Multichannel urodynamic studies-uroflowmetry and cystometry.
USG – Transabdominal, Transrectal
CT Scan and MRI
7.4 Has the ethical clearance been obtained from ethical committee of your Institution?
“Yes”, ethical clearance has been obtained.
Results will be analyzed by using appropriate statistical tests.
LIST OF REFERENCES
1) Snjezana Milicevic, Predrag Grubor, Nenad Lucic. The evaluation of impact of BPH Surgical treatment with the Open Prostatectomy and Transurethral Resection of the Prostate methods on the quality of life. MED ARH 2011; 65(5): 274-277
2) Bernardo Rocco et al. Recent advances in the Surgical Treatment of Benign Prostatic Hyperplasia. Ther Adv Urol. 2011; 3(6):263-372
3) S.R. Keoghane et al. A double-blind randomized controlled trial and economic evaluation of transurethral resection vs contact laser vaporization for benign prostatic enlargement: a 3-year follow-up. BJU International (2000); 85: 74-78
hyperplasia and laser therapy from 2007-2008 to 2011-2012. Can Urol Assoc J 2013;7(9-10)
5) Wei J. Fu et al. Comparison of 2-micro m Continuous Wave Laser Vaporesection of the
Prostate and Transurethral Resection of the Prostate: A Prospective Nonrandomized Trial With 1-year Follow-up. Urology 2010; 75:194–199
6) A. Shaheen and D. Quinlan. Feasibility of open simple prostatectomy with early vascular control. BJU Int. 2004; 93: 349-352
7) Pamela Dull, Robert W. Reagan, and Robert R. Bahnson. Managing Benign Prostatic Hyperplasia. Am Fam Physician 2002;66:77-84,87-8.
8) Sascha A. Ahyai et al. Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Enlargement. European Urology 2010; 583: 84-397
9) Alexander Bchmann et al. PhotoselectiveVaporization of the Prostate: The Basel Experience after 108 Procedures. European Urology 2005; 47:798–804.
10) Narmada Gupta, Sivaramakrishna, Rajeev Kumar, Prem N. Dogra and Amlesh Seth. Comparison of standard transurethral resection, transurethral vapour resection and Holmium laser enucleation of the prostate for managing benign prostatic hyperplasia of >40g. BJU Int. 2006; 97: 85-89
11) Riyadh F. Talic, Abdul-Moniem El Tiraifi, Salah R. El Faqih, Salah H. Hassan,
Ramiz A. Attassi, and Rabie E. Abdel-Halim. Prospective Randomized study of Transurethral vaporization resection of prostate using the thick loop and standard transurethral prostatectomy. Urology 2000; 55: 886-891
12) Abdulla Al-Ansari et al. GreenLight HPS 120-W Laser Vaporization Versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia: A Randomized Clinical Trial with Midterm Follow-up. European Urology 2010; 58:349–355
13) Kim et al. Twelve-Month Follow-up Results of Photoselective Vaporization of the Prostate With a 980-nm Diode Laser for Treatment of Benign Hyperplasia. Korean J Urol. 2013; 54(10): 677–681.
14) Patel et al. Transurethral electrovaporization and vapour-resection of the prostate: an appraisal of possible electrosurgical alternatives to regular loop resection. BJU International 2000; 85:202-210.
15) M.Y. Hammadeh, G.A. Fowlis, M. Singh and T. Philip. Transurethral electrovaporization of the prostate – a possible alternative to transurethral resection: a one-year follo-up of a prospective randomized trial. British Journal of Urology 1998; 81:721-725.
16) Jens Rassweiler et al. Complications of Transurethral Resection of the Prostate (TURP)—Incidence, Management, and Prevention. European Urology 2006; 50:969-980.
17) O.I. Aisuodionoe-Shadrach and L.E. Akporiaye. Outcome of the TURP-TUVP sandwich procedure for minimally invasive surgical treatment of benign prostatic hyperplasia with volume larger than 40cc over a 4-year period in Nigeria. African Journal of Urology 2013; 19: 22–25.
18) M. Cetinkaya et al. A comparison of fluid absorption during transurethral resection and transurethral vaporization for benign prostatic hyperplasia. BJU International 2000; 86:820-823.
19) Chung-Jing Wang. Surgical Intervention for Male Lower Urinary Tract Symptoms with Benign Prostatic Hyperplasia. Incont Pelvic Floor Dysfunct 2009; 3(2):41-47.
20) Mihir M. Desai et al. Single-port transvesical enucleation of the prostate: a clinical report of 34 cases. BJU Int. 2009; 105:1296–1300.