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Vasectomy: What are community standards?
VASECTOMY: WHAT ARE COMMUNITY RICHARD ROBERT
K. BABAYAN, J. KRANE,
STANDARDS?
M.D.
M.D.
From the Department of Urology, Boston University Medical Center,
University Hospital at Boston, Massachusetts
ABSTRACT-Vasectomy has become an increasingly popular mode of contraception in OUTsociety. It is also a procedure which places the urologist at an uncommonly high risk for litigation. To better asses.s the manner in which urologists within a geographical region treat their vasectomy patients, a survey was conducted of the members of the New England Section, American Urological Association. The results of that survey are presented.
A survey of 365 members of the New England Section, American Urological Association, Inc., was conducted to ascertain the standard management and care provided to patients seeking elective vasectomy. The survey was intended to reveal the following information: (1) the number of vasectomies performed annually, (2) the preoperative information provided to patients, including the extent of informed consent, (3) the surgical techniques used by the urologist, and (4) the post-vasectomy follow-up care. Of the 365 urologists surveyed, responses were obtained from 281 (77 % ). The results obtained from this survey are summarized in Tables I to IV Comment It is estimated that 500,000-l million elective vasectomies are performed annually in the
TARLE I.
328
Number
of vasectomies/year
Vasectomv
No. (%)
0 1-15 16-40 > 40
23 (7.8) 35 (12.4) 89 (31.7) 134 (47.8)
TABLE
II.
Preoperative
considerations
Question
Do you discuss the potential for recanalization Do you have separate consent form for vasectomy If yes, is recanalization mentioned on consent form If patient is married, do you require spousal consent
Yes
No
246
13
235
23
138
103
191
68
United States. ’ Vasectomy is most commonly performed as an office procedure under local anesthesia and has a reported complication rate of 2-3 per cent and a failure rate of less than 1 per cent.2.3 In spite of these low figures, it is also estimated that vasectomy results in the highest number of malpractice cases filed against urologists, accounting for over 50 per cent of such litigation.4 The most common allegation is either surgical complication or failure to provide proper informed consent. In a special article concerning surgical liability for vasectomy, Beal suggests that “protection begins at home.” He stresses that certain principles be followed to help avoid litigation over vasectomy. These include (1) selectivity in
UROLOGY
i APRIL 1986
/ VOLUME
XXVII,NUMBER4
TAHLE: III.
Surgical
technique
TARLE
3.
4.
5.
6.
7.
8.
Lidocaine 2%) 78 Lidocaine 1% , 160 Lidocaine 0.5 % , 9 Other anesthetic, 11 Vas ligation Suture alone 116 Suture and cautery 66 Suture and clips 8 Suture, clips and cautery 2 Clips alone 29 Cautery alone 19 Clips and cautery 19 Type of suture Chromic 101 Dexonivycril 17 Plain catgut 10 Nonabsorbable 66 Do you routinely turn back ligated ends of vas? Yes, both ends 43 Yes, one only 34 No, 181 Do you close fascia over ligated stump? Yes, both ends 28 Yes, one only 93 No, 137 Do you routinely excise a segment of vas? Yes, 236 No, 22 If yes, how long? 5 1 cm, 27 l-2 cm. 120 > 2 cm, 25 variable, 3 What is done with excised segment? Sent for pathology examination, 135 Keep until count 0, 27 Keep forever, 2 Discard, 72 Did not respond, 23 Do you routinely use antibiotics? Yes, 61 No, 198 If yes, what type? Tetracycline, 41 Ampicillin, 7 Cephalosporin, 5 Sulfa, 3 Variable, 5
vasectomy, (2) both husband and wife be fully informed about the procedure and the expected results, (3) the need for strict compliance with postoperative instructions and incidence of failure be stressed, and (4) the informed consent form be in compliance with the
1
APRIL
1986
/
VOLUME
XXVII,
NUMBER
follow-up
law and should reflect all that the urologist has discussed with the patient. In conducting our survey, we did not expect to find a single community standard for vasectomy, but rather to determine what the general consensus of the urologic community was in their routine approach to vasectomy, given the aforementioned precautions as to the potential for litigation from this operation. A small number of respondents (7.8 % ) claimed not to perform elective vasectomy at all. They cited either personal religious beliefs or the fear of potential litigation. However, as is apparent from Table I, most urologists surveyed commonly performed this procedure (almost half the respondents reported doing more than 40 vasectomies annually). We were somewhat surprised that more than 39 per cent of the respondents did not include the possibility of recanalization in their informed-consent forms and over one quarter of those surveyed did not seek the spouse’s consent. It was not surprising that a wide variety of surgical techniques were utilized. Many of the urologists responded with detailed descriptions of how they had modified their surgical techniques over the years. Clearly, there does not appear to be a consensus regarding surgical technique or type of suture material used.
performing
UROLOGY
Postvasectomy
1. When do you obtain semen analysis? 2-S weeks, 38 6-8 weeks, 97 >8 weeks, 87 6-10 ejaculations, 13 11-20 ejaculations, 27 2. How many 0 sperm counts do you require? o-1 1-143 2-105 >2-10 3. Do you examine semen analysis yourself:? Yes, 178 No, 79 4. Do you depend on technicians report? Yes. 86 No, 51 5. Have you ever had recanalization occur? Yes, 118 No, 139 6. Have you ever been involved in litigation related to vasectomy? Yes, 29 No, 238
1. Anesthesia
2.
IV.
4
In reviewing the responses to the questions on postvasectomy follow-up, again there was no consensus on what constituted proper management. This is well reflected in Table IV (item 1). In response to when follow-up semen analysis should be obtained, answers were given both in time from the vasectomy as well as in the actual number of ejaculations after vasectomy, Recanalization was noted by 118 respondents, although the actual rate of recanalization could not be determined by this survey. In spite of this rather large number of recanalizations, only 29 of 257 urologists who answered the question reported ever being involved in litigation relating to vasectomy. It is statistically significant that all 29 who reported they had litigation involving vasectomy also reported the occurrence of recanalization, although no cause-and-effect relationship can be concluded from this association. No statistical correlation could be drawn between those reporting recanalization and the technique each used and between those reporting litigation and the con-
330
tent of the preoperative information made available to their patients. Our survey was not performed with any preconceived notions, and we did not expect to make any sweeping generalizations about what constitutes community standards for vasectomy. We have attempted to survey the preferences of practicing urologists within a certain geographic region and present the data for peer review and examination. Boston,
75 East Newton Street Massachusetts 02118 (DR. BABAYAN)
References 1. Lipshultz LI, and Berson GS: Vasectomy-1980, Urol Clin North Am 7: 89 (1980). 2. Kaplan KA, and Huether CA: A clinical study of vasectom! failure and recanalization, J Ural 113: 71 (1975). 3. Leader AJ, Axelrad SD, Frankowski R, and Mumford SD: Complications of 2,711 vasectomies, ihid 111: 365 (1974). 4. West PJ, and Bartelt RC: Medicolegal aspects of urology, Urol Clin North Am 7: 153 (1980). 5. Beal DA: Vasectomy and lowering surgeon’s risk of liability, Urology 12: 682 (1978).
UROLOGY
/
APRIL
1986
/
VOLUME
XXVII,
NUMBER
4
K. BABAYAN, J. KRANE,
STANDARDS?
M.D.
M.D.
From the Department of Urology, Boston University Medical Center,
University Hospital at Boston, Massachusetts
ABSTRACT-Vasectomy has become an increasingly popular mode of contraception in OUTsociety. It is also a procedure which places the urologist at an uncommonly high risk for litigation. To better asses.s the manner in which urologists within a geographical region treat their vasectomy patients, a survey was conducted of the members of the New England Section, American Urological Association. The results of that survey are presented.
A survey of 365 members of the New England Section, American Urological Association, Inc., was conducted to ascertain the standard management and care provided to patients seeking elective vasectomy. The survey was intended to reveal the following information: (1) the number of vasectomies performed annually, (2) the preoperative information provided to patients, including the extent of informed consent, (3) the surgical techniques used by the urologist, and (4) the post-vasectomy follow-up care. Of the 365 urologists surveyed, responses were obtained from 281 (77 % ). The results obtained from this survey are summarized in Tables I to IV Comment It is estimated that 500,000-l million elective vasectomies are performed annually in the
TARLE I.
328
Number
of vasectomies/year
Vasectomv
No. (%)
0 1-15 16-40 > 40
23 (7.8) 35 (12.4) 89 (31.7) 134 (47.8)
TABLE
II.
Preoperative
considerations
Question
Do you discuss the potential for recanalization Do you have separate consent form for vasectomy If yes, is recanalization mentioned on consent form If patient is married, do you require spousal consent
Yes
No
246
13
235
23
138
103
191
68
United States. ’ Vasectomy is most commonly performed as an office procedure under local anesthesia and has a reported complication rate of 2-3 per cent and a failure rate of less than 1 per cent.2.3 In spite of these low figures, it is also estimated that vasectomy results in the highest number of malpractice cases filed against urologists, accounting for over 50 per cent of such litigation.4 The most common allegation is either surgical complication or failure to provide proper informed consent. In a special article concerning surgical liability for vasectomy, Beal suggests that “protection begins at home.” He stresses that certain principles be followed to help avoid litigation over vasectomy. These include (1) selectivity in
UROLOGY
i APRIL 1986
/ VOLUME
XXVII,NUMBER4
TAHLE: III.
Surgical
technique
TARLE
3.
4.
5.
6.
7.
8.
Lidocaine 2%) 78 Lidocaine 1% , 160 Lidocaine 0.5 % , 9 Other anesthetic, 11 Vas ligation Suture alone 116 Suture and cautery 66 Suture and clips 8 Suture, clips and cautery 2 Clips alone 29 Cautery alone 19 Clips and cautery 19 Type of suture Chromic 101 Dexonivycril 17 Plain catgut 10 Nonabsorbable 66 Do you routinely turn back ligated ends of vas? Yes, both ends 43 Yes, one only 34 No, 181 Do you close fascia over ligated stump? Yes, both ends 28 Yes, one only 93 No, 137 Do you routinely excise a segment of vas? Yes, 236 No, 22 If yes, how long? 5 1 cm, 27 l-2 cm. 120 > 2 cm, 25 variable, 3 What is done with excised segment? Sent for pathology examination, 135 Keep until count 0, 27 Keep forever, 2 Discard, 72 Did not respond, 23 Do you routinely use antibiotics? Yes, 61 No, 198 If yes, what type? Tetracycline, 41 Ampicillin, 7 Cephalosporin, 5 Sulfa, 3 Variable, 5
vasectomy, (2) both husband and wife be fully informed about the procedure and the expected results, (3) the need for strict compliance with postoperative instructions and incidence of failure be stressed, and (4) the informed consent form be in compliance with the
1
APRIL
1986
/
VOLUME
XXVII,
NUMBER
follow-up
law and should reflect all that the urologist has discussed with the patient. In conducting our survey, we did not expect to find a single community standard for vasectomy, but rather to determine what the general consensus of the urologic community was in their routine approach to vasectomy, given the aforementioned precautions as to the potential for litigation from this operation. A small number of respondents (7.8 % ) claimed not to perform elective vasectomy at all. They cited either personal religious beliefs or the fear of potential litigation. However, as is apparent from Table I, most urologists surveyed commonly performed this procedure (almost half the respondents reported doing more than 40 vasectomies annually). We were somewhat surprised that more than 39 per cent of the respondents did not include the possibility of recanalization in their informed-consent forms and over one quarter of those surveyed did not seek the spouse’s consent. It was not surprising that a wide variety of surgical techniques were utilized. Many of the urologists responded with detailed descriptions of how they had modified their surgical techniques over the years. Clearly, there does not appear to be a consensus regarding surgical technique or type of suture material used.
performing
UROLOGY
Postvasectomy
1. When do you obtain semen analysis? 2-S weeks, 38 6-8 weeks, 97 >8 weeks, 87 6-10 ejaculations, 13 11-20 ejaculations, 27 2. How many 0 sperm counts do you require? o-1 1-143 2-105 >2-10 3. Do you examine semen analysis yourself:? Yes, 178 No, 79 4. Do you depend on technicians report? Yes. 86 No, 51 5. Have you ever had recanalization occur? Yes, 118 No, 139 6. Have you ever been involved in litigation related to vasectomy? Yes, 29 No, 238
1. Anesthesia
2.
IV.
4
In reviewing the responses to the questions on postvasectomy follow-up, again there was no consensus on what constituted proper management. This is well reflected in Table IV (item 1). In response to when follow-up semen analysis should be obtained, answers were given both in time from the vasectomy as well as in the actual number of ejaculations after vasectomy, Recanalization was noted by 118 respondents, although the actual rate of recanalization could not be determined by this survey. In spite of this rather large number of recanalizations, only 29 of 257 urologists who answered the question reported ever being involved in litigation relating to vasectomy. It is statistically significant that all 29 who reported they had litigation involving vasectomy also reported the occurrence of recanalization, although no cause-and-effect relationship can be concluded from this association. No statistical correlation could be drawn between those reporting recanalization and the technique each used and between those reporting litigation and the con-
330
tent of the preoperative information made available to their patients. Our survey was not performed with any preconceived notions, and we did not expect to make any sweeping generalizations about what constitutes community standards for vasectomy. We have attempted to survey the preferences of practicing urologists within a certain geographic region and present the data for peer review and examination. Boston,
75 East Newton Street Massachusetts 02118 (DR. BABAYAN)
References 1. Lipshultz LI, and Berson GS: Vasectomy-1980, Urol Clin North Am 7: 89 (1980). 2. Kaplan KA, and Huether CA: A clinical study of vasectom! failure and recanalization, J Ural 113: 71 (1975). 3. Leader AJ, Axelrad SD, Frankowski R, and Mumford SD: Complications of 2,711 vasectomies, ihid 111: 365 (1974). 4. West PJ, and Bartelt RC: Medicolegal aspects of urology, Urol Clin North Am 7: 153 (1980). 5. Beal DA: Vasectomy and lowering surgeon’s risk of liability, Urology 12: 682 (1978).
UROLOGY
/
APRIL
1986
/
VOLUME
XXVII,
NUMBER
4