Vol. 109, June
THE JOURNAL OF UROLOGY
Printed in U.S.A.
Copyright © 1973 by The Williams & Wilkins Co.
AN ASSESSMENT OF CRYOSURGERY IN THE TREATMENT OF'PROSTATIC OBSTRUCTION A. MARSHALL, A. K. BROWN, W.W. JONES
AND
R. M. LINDSAY
From the Department of Urology, Royal Infirmary, Glasgow, Scotland
Gonder and associates, after experimental work on the dog prostate, were the first to describe the use of cryosurgery in the treatment of the enlarged prostate in man. 1 Excellent results have been reported by many investigators following the use of prostatic cryosurgery. 2 -• However, Ortved and associates studied the technique and gave it up as valueless.7 Cryosurgery is used by many in the treatment of certain cases of prostatic obstruction. s-1• We worked for more than a year to gain experience in prostatic cryosurgery. Our assessment of this new method in comparison to conventional methods of prostatectomy is reported herein. MATERIAL AND METHODS
The study includes 100 patients with prostatic obstruction who had operations in the same hospital between February 1968 and April 1969. PaAccepted for publication October 27, 1972. 1 Gonder, M. J., Soanes, W. A. and Schulman, S.: Cryosurgical treatment of the prostate. Invest. Urol., 3: 372, 1966. 2 Dow, J. A., Coughlin, J. D. and Waterhouse, K.: Lethal freezing temperatures of the surgical capsule and cryosurgery of the prostate. J. Urol., 104: 459, 1970. 'Reuter, H.: Die Kaltechirurgie im Rahmen der Prostataoperationen. Urol. Int., 24: 145, 1969. 'Roberts, M., Lattimer, J. K., Tannenbaum, M. and Ehrlich, R. M.: The place of cryoprostatectomy. Trans. Amer. Ass. Genito-Urin. Surg., 60: 58, 1968. 'Rouvalis, P.: Der heutige Stand der Kaltechirurgie der Prostata und unsere Erfahrung in 400 Fallen. Urologe, 9: 279, 1970. • Soanes, W. A., Gonder, M. J., Albin, R. J., Maser, M. D. and Jagodzinski, R. V.: Clinical and experimental aspects of prostatic cryosurgery. J. Cryosurg., 2: 23,
1969. 1 Ortved, W. E., O'Kelly, F. M., Todd, I. A. D., Maxwell, J. B. and Sutton, M. R.: Cryosurgical prostatectomy. Brit. J. Urol., 39: 577, 1967. "Dowd, J. B., Flint, L. D., Zinman, L. N. and Tripathi, V. N. P.: Experiences with cryosurgery of the prostate in the poor-risk patient. Surg. Clin. N. Amer.,
tients were numbered from 1 to 100 at random. Odd numbered patients had cryosurgery and even numbered patients had some conventional form of prostatectomy, carried out by the retropubic or transvesical route or by transurethral resection (TUR). Cryosurgery was performed with the use of the apparatus developed by Gonder and associates.' Freezing time was never more than 7 minutes at one sitting and the temperature was minus 160C. Anesthesia used was as described previously .13 A local anesthetic was used in 3 cases. In all cases a complete medical history was obtained and full physical examination was performed. All patients had a chest x-ray, electrocardiogram, full blood count, excretory urogram (IVP), blood urea nitrogen (BUN) and electrolyte studies. Urine culture and sensitivity tests were made when indicated. The average age of patients was 71.1 years for those who underwent cryosurgery and 71.3 years for those who underwent a conventional operation. The range of all patients was 54 to 88 years. The size of the prostate gland was estimated by preoperative rectal examination. The average size was 31.4 gm. (range 10 to 100 gm.) in those who had cryosurgery and 31.1 gm. (range 10 to 150 gm.) in those treated by conventional methods. The salient clinical features are noted in table 1. Patients in the conventional group with marked cardio-respiratory lesions were subjected to a limited (palliative) TUR. Advanced neoplasm outside the urinary tract existed in several patients. One patient had metastatic lesions from a primary bladder carcinoma. Followup of patients was continued for at least 2 years or until death. Special note was made of subsequent admissions to the hospital, cause of death, ease of voiding, urinary control and urinary infection at the end of 2 years.
48: 627, 1968.
"Hansen, R. I., Lund, F. and Backer, 0. G.: Cryosurgery of the prostate. Urol. Int., 24: 160, 1969. 10 Gill, W., Fraser, J., Long, W. and Lee, P.: An experience with cryoprostatectomy. Surg., Gynec. & Obst., 131:877, 1970. u Green, N. A.: Cryosurgery of the prostate gland in the unfit subject. Brit. J. Urol., 42: 10, 1970. 12 Kishev, S. L., Coughlin, J. D. and Dow, J. A.: Late results following cryosurgery of the prostate (a clinical and panendoscopic study of 80 patients). J. Urol., 104: 893, 1970. 13 Marshall, A.: Cryogenic surgery of the prostate. Proc. Roy. Soc. Med., 61: 1139, 1968. 14 Sesia, G., Ferrando, U. and Laudi, M.: Follow-up results in cryotherapy of prostate obstruction. J. Cryosurg., 1: 254, 1968.
1026
RESULTS
A blood transfusion was necessary during or soon after the operation in 22 patients who had conventional therapy and in only 2 who had cryosurgery. Table 2 shows the postoperative morbidity and mortality rates occurring in each group during hospitalization. Further operative procedure ( either evacuation or resection of slough or a second TUR) was more usual in patients who had cryosurgery. No significant statistical difference for complications and mortality was noted. The patient who died following cryotherapy was
1027
CRYOSURGERY IN TREATMENT OF PROSTATIC OBSTRUCTION TABLE
1. Salient clinical findings Cryosurgery
Cardio-respiratory status very poor Advanced neoplasm Urinary retention Urinary infection Abnormal IVP
TABLE
Conventional Operation
9
11
4 22 11 15
2 20 17 12
2. Complications and mortality rate during
hospitalization
Second operation or removal of slough Failure to void after repeated operation Poor urinary control Swelling of scrotum Rigors, pyrexia Severe pain on micturition Suprapubic urinary leak Death
Cryosurgery
Conventional Operation
10
4
2 1 4
2 1 0
olapaxy. Following retropubic prostatectomy 1 patient was readmitted to the hospital with chronic osteitis pubis. One patient who had TUR was hospitalized 5 months postoperatively with acute urinary retention. However, he voided spontaneously on admission. Table 3 lists in detail the deaths which occurred within 2 years of the first discharge from the hospital. Autopsy findings in the 2 patients who died after readmission to the hospital included marked pyelonephritis and purulent bronchitis in one and myocardial infarction in the other. The former had non-functioning kidneys on IVP, urinary infection and a preoperative BUN of more than 100 mg. per 100 ml. In all cases in which carcinoma was the cause of death the diagnosis had been made while the patient was in the hospital.
5 1
DISCUSSION
1
There was no significant statistical difference in age, prostatic size or general preoperative condition of the patient between the 2 groups. Of those who had cryosurgery 18 patients either needed a further operation (for example resection of slough) before discharge from the hospital or were subsequently readmitted because of some demanding urinary problem (often retention caused by slough). Another operation or readmission was required in only 6 of those in the conventional therapy group. The difference is statistically significant (X 2 = 6.952 n = 1, p less than 0.01). Two years after initial discharge from the hospital there was no significant statistical difference in the clinical status of patients surviving in either group. During those 2 years more deaths occurred in the group of patients who had cryosurgery. The difference is not statistically significant. Considering the preoperative clinical status of many of these patients the high death rate in the
0 4 0
86 years old and died of pneumonia. The bladder and kidneys were normal and the prostate gland was partially necrotic. Postoperative catheter drainage was required for 7 days or more in 34 patients treated with cryosurgery and 12 patients treated with conventional operations. The difference is statistically significant (X 2 = 16.1, n = 1, p less than 0.01). Postoperative hospitalization was 13 days or less for 38 patients who had cryosurgery and for 41 patients who had conventional therapy. BUN 3 days postoperatively rose to 20 mg. per 100 ml. in 9 patients who had cryosurgery and 14 patients who had conventional therapy. In all cases the level had returned to preoperative values 7 days postoperatively. Hemoglobin decreased to 2 gm. per 100 ml. 7 days postoperatively in 11 patients who had cryosurgery. Thereafter, with iron therapy the level began to rise. Hemoglobin decreased to amounts varying from 2 to 6 gm. per 100 ml. 7 days postoperatively in 19 patients who underwent conventional operations. Again these levels rose with iron therapy, supplemented in 2 cases by blood transfusion. A 2-year followup revealed that the percentage of patients who could void easily with good control was equal in the 2 groups. About a third of the patients in each group had urinary infection although they were asymptomatic. During the 2-year followup, and in fact mainly during the first 3 months postoperatively, there was a high incidence of readmission to the hospital of patients who had cryosurgery. In most cases slough had to be evacuated or resected. Two patients had bladder stones and required lith-
TABLE
3. Deaths occurring within 2 years after first
discharge from hospital Time After Operation 5wks. 2mos.
3mos. 4mos. 5mos. 7mos. 8mos. 9mos. 14 mos. 15 mos. 19mos. 21 mos.
Cryosurgery
Conventional Surgery
Pyelonephritis, bronchitis Coronary thrombosis Pyelonephritis, myocardial infarction Secondaries, bladder neoplasm Coronary thrombosis (2 cases) Pulmonary Ca Colonic Ca Prostatic Ca Pneumonia Cerebral hemorrhage Bronchial Ca
Cardiac asthma Congestive cardiac failure
Prostatic neoplasm metastases Gastric Ca
1028
MARSHALL AND ASSOCIATES
2-year followup period is not surprising. In fact 2 patients who had a very poor cardio-respiratory status died before the operation. Of the 100 patients studied only 1 needed another operation because of prostatic tissue regrowth during the 2 years of followup. Another operation (palliative TUR) was required at 18 months in this patient who had a poorly differentiated prostatic carcinoma. His first operation had been a limited resection. Urinary infection pe!sisted in about a third of the patients in each group throughout the period of review. Infection was undoubtedly caused by irregularities in contour of the prostatic urethra, which persisted after either cryosurgery or palliative TUR. The 2-year postoperative results of patients with very poor cardio-respiratory conditions, that is very poor risk patients, are noteworthy. In the poor risk group 9 patients had cryosurgery and 11 had conventional operations. At the end of 2 years, 4 of the 9 patients who had cryosurgery were voiding easily with good control, 1 was incontinent and 4 had died. Of the 11 patients who had conventional operations (palliative TUR), 7 were voiding easily with good control, 3 had died and 1 was lost to followup. CONCLUSIONS
Because of the high morbidity rate following cryosurgery, requiring additional operative procedures, and because only partial removal of obstructing tissue is obtained, this method has no place in the routine treatment of prostatic obstruction. Very poor risk patients do just as well with a palliative TUR. However, cryosurgery may occasionally be advantageous for very poor risk patients in whom only local anesthetic can be
contemplated. Cryosurgery occasionally may be of value in patients with prostatic obstruction in the presence of blood dyscrasias or in patients given prolonged anticoagulant therapy. SUMMARY
One hundred patients with prostatic obstruction were studied. Fifty patients underwent cryosurgery and 50 were treated with a conventional method of prostatectomy. The 2 groups were comparable in age, prostatic size, urinary tract and general physical status. Followup was for 2 years or until the patient's death. It is concluded that with present techniques cryosurgery has very few indications in the treatment of prostatic obstruction even in very poor risk patients. The apparatus used for prostatic cryosurgery was purchased with a grant from the Scottish Hospitals Endowment Research Trust. REFERENCES CAHAN, W. G.: Cryosurgery of malignant and benign tumors. Fed. Proc., 24: S241-G, 1965. COOPER, I. S. AND LEE, A. S.: Cryothalamectomy-hypothermic congelation: a technical advance in basal ganglia surgery. Preliminary report. J. Amer. Geriat. Soc., 9: 714, 1961. COOPER, I. S.: Cryogenic surgery of the basal ganglia. J.A.M.A., 181: 600, 1962. CooPER, I. S.: Cryogenic surgery. A new method of destruction or extirpation of benign or malignant tissues. New Engl. J. Med., 268: 743, 1963. DOWD, J. B.: Transurethral cryogenic surgery of the prostate. Lahey Clin. Bull., 19: 141, 1970. KRWAwrcz, T.: Further results of surgery in swelling cataract with the use of cryo-extraction. Klin. Oczna., 31: 201, 1961. SESIA, G., FERRANDO, U. AND LAUD!, M.: The use of nitrous oxide as a freezing agent in cryosurgery of the prostate. Int. Surg., 53: 82, 1970. SOANES, w. A., GONDER, M. J. AND SHULMAN, S.: Apparatus and technique for cryosurgery of the prostate. J. Urol., 96: 508, 1966.