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Trial of Ibuprofen to Prevent Post-Vasectomy Complications
0022-534 7/88/1395-0965$02.00/0 Vol. 139, May
THE JOURNAL OF UROLOGY
Printed in U.S.A.
Copyright© 1988 by The Williams & Wilkins Co.
TRIAL OF IBUPROFEN TO PREVENT POST-VASECTOMY COMPLICATIONS ALAN L. MANSON* From the Department of Urology, Naval Hospital, Great Lakes, Illinois
ABSTRACT
Sperm granuloma and epididymitis remain 2 of the most common and incapacitating complications of vasectomy. A study was designed to evaluate the possibility of reducing these inflammatory complications with a prophylactic course of a nonsteroidal anti-inflammatory drug. Patients undergoing outpatient vasectomy were randomized into 2 groups. Group 1 received a prophylactic course of ibuprofen and group 2 received no medication. The ibuprofen was tolerated well and no adverse reactions were noted. There was no increase in postoperative bleeding or hematoma formation. There was no clinical benefit or decrease in complication rate in the ibuprofen-treated group. (J. Ural., 139: 965-966, 1988) Vasectomy is one of the most common urological procedures, with an estimated 750,000 performed in 1971.1 It is considered safe, well tolerated and technically simple means of elective sterilization. Significant complications are rare and consist of hematoma, sperm granuloma, wound infection, abscess, epididand recanalization. 1-• Attempts to decrease postoperative discomfort and lower the complication rate have included changes in technique,2· 5 trials of steroid injection or prophylactic antibiotics. 6 Nonsteroidal anti-inflammatory drugs recently have been extensively studied. One of the safest and most widely studied of these drugs is ibuprofen, which currently is being tested for postoperative pain, arthritis, dysmenorrhea, postoperative per, itoneal adhesions and as an adjunct for vascular surgery or after myocardial infarction. 7• 8 It is relatively inexpensive and it usually is tolerated better than aspirin or other nonsteroidal anti-inflammatory drugs. 7 ' 9 The potential use of ibuprofen after vasectomy is examined in an effort to decrease inflammatory complications (sperm granuloma and epididymitis). METHODS AND MATERIALS
Between July 1986 and May 1987, 102 men 25 to 46 years old underwent vasectomy with the patient under local anesthesia in an outpatient setting. Through bilateral scrotal incision the vasa deferentia were isolated and a 2 cm. segment of each was excised. Both proximal and distal transected ends of the vasa were electrofulgurated and then ligated with chromic sutures. Hemostasis was ensured and the wounds were closed with chromic sutures. A sterile compressive scrotal dressing was applied. The patients were alternately selected randomly into 2 groups. Group 1 received a 7-day course of 800 mg. ibuprofen 3 times daily and group 2 was given no medication. Contraindications to inclusion in this study included a history of coagulation abnormalities, peptic ulcer disease, gastrointestinal bleeding, renal disease or previous hypersensitivity. All patients were instructed to remain at bed rest for the remainder of that and to apply an ice pack. patients returned in 2 weeks for followup. They also were instructed to return at any time for increasing pain, swelling or signs of infection. During this examination specific attention was directed to the possible presence of a hematoma, early
granuloma, epididymitis or infection. After this appointment the patients were told again to return to the clinic at any time for any subsequent problems. A semen analysis was obtained at 6 to 8 weeks. A sperm granuloma was defined as a firm, tender nodule at the vasectomy site. Epididymitis was identified by localized epididymal tenderness, edema and induration. RESULTS
Of the 102 men studied 95 (93.l per cent) returned for the followup examination: 46 were in group 1 (ibuprofen) and 49 were in group 2 (no medication). Although it may be presumed that the patients who did not return for the scheduled followup were free of significant complication, they were excluded from the study. Minimal scrotal edema, ecchymosis and discomfort were considered expected insignificant findings and, therefore, they were excluded from the list of complications. Significant postoperative complications included hematoma, sperm granuloma and epididymitis. There were no wound infections or scrotal abscesses. All hematomas were considered small (less than 3 cm.) and none required drainage. The cases of epididymitis resolved with scrotal elevation and support, bed rest, sitz baths and anti-inflammatory drugs (if the patient currently was not on ibuprofen). Although most episodes of epididymitis are presumed to be related to passive congestion with inflammation secondary to mucosa! separation and extravasation of sperm, infectious etiologies cannot be excluded entirely and, thus, all patients also were treated with a 10-day course of antibiotics. No patients suffered any reactions or complications while on the ibuprofen. There was no increase in postoperative bleeding or hematoma formation. Complications occurred in 8.4 per cent of the patients. There was no statistically significant difference in the total complication rate or individual complications between groups 1 and 2 (see table).
Incidence of complications in patients on ibuprofen (group 1) and those given no medication (group 2)
No. pts. Complication: Hematoma Sperm granuloma Epididymitis Totals
Accepted for publication August 18, 1987. The views expressed herein are those of the author and do not necessarily reflect the views of the United States Navy or the Department of Defense. * Current address: Department of Urology, Naval Hospital, Oakland, California 94627. 965
Group 1 No.(%)
Group 2 No.(%)
Total No.(%)
46
49
95
1 1 3 5
(2.2) (2.2) (6.5) (10.9)
1 (2.0) 2 (4.1) 0 3 (6.1)
2 3 3 8
(2.1) (3.2) (3.2) (8.5)
966
MANSON DISCUSSION
Complications from vasectomy generally are considered to be uncommon and relatively minor in nature. However, owing to the large number of these procedures performed each year, these complications assume more clinical importance. Mild scrotal edema, bruising and minimal discomfort are noted commonly and they are rarely of clinical significance. 2 • 6 More troublesome complications include hematoma, infection, sperm granuloma, epididymitis and recanalization. Leader and associates extensively reviewed the literature and reported incidences of epididymitis of 0.4 to 6.1 per cent, scrotal abscess 5.5 per cent, failure O to 6.0 per cent, sperm granuloma 4.9 to 10.0 per cent, cellulitis 1.5 per cent and hematoma O to 18.2 per cent. 2 Our complication rates certainly were within these limits (epididymitis 3.2 per cent, sperm granuloma 3.2 per cent, infection O per cent and hematoma 2.1 per cent). The incidence of certain complications (hematoma, infection and perhaps sperm granuloma) may be decreased with attention to strict aseptic conditions, meticulous hemostasis, use of modern surgical technique and a compressive scrotal dressing. Further attempts to decrease post-vasectomy complications have included trials of steroids and prophylactic antibiotics. 6 However, since post-vasectomy epididymitis and sperm granuloma are inflammatory in character and only rarely infectious in nature, prophylactic antibiotics would not appear to be indicated. Steroid therapy would be expected to modify or blunt postoperative inflammation. However, steroids generally are considered therapeutic overkill. Sperm granuloma and epididymitis represent 2 of the most common and incapacitating post-vasectomy complications. Sperm granulomas are believed to result from a focal intense granulomatous inflammatory response to extravasated sperm by the perivasal tissues. Some reports indicated that perhaps technical details may be modified to decrease the incidence of this condition. 6 Epididymitis is believed to result from obstructive engorgement or congestion with associated pain and swelling, and disruption of the epididymal tubules with secondary focal small sperm granulomas. 10 Although it has been reported that the open-ended vasectomy technique may decrease the incidence of epididymitis, 11 there still is some concern that it also may be associated with an increased risk of sperm granuloma or recanalization. This study was intended to define a potential role for nonsteroidal anti-inflammatory drugs to prevent or decrease the incidence of post-vasectomy inflammatory conditions (epididymitis and sperm granulomas) without increasing postoperative bleeding or hematoma formation. Such drugs currently are
being tested in a variety of inflammatory conditions with promising results. The current concept of their action is that they inhibit cyclo-oxygenase, which is an enzyme necessary to produce certain prostaglandins (prostaglandin E2 and prosta glandin F2) that are potent mediators of inflammation. 12 They also interfere with leukocyte migration and probably with leukocyte function. One of the most extensively studied and least toxic of the nonsteroidal anti-inflammatory drugs is ibuprofen. 7- 9 Jbuprofen is a well tolerated and inexpensive drug that is readily available and has been shown to have less gastric irritability than aspirin or other nonsteroidal anti-inflammatory drugs. Our study demonstrated that ibuprofen was tolerated well and no adverse reactions to the medication were noted. In addition there was no increase in postoperative bleeding or hematoma 'formation. Unfortunately, there also was no obvious benefit or reduction in complication rates with this regimen. Its use for prophylaxis after vasectomy cannot be recommended I,
•
Dr. Donald Kidd contributed to this study.
REFERENCES
1. Esho, J. 0., Cass, A. S. and Ireland, G. W.: Morbidity associated with vasectomy. J. Urol., 110: 413, 1973. 2. Leader, A. J., Axelrad, S. D., Frankowski, R. and Mumford, S. D.: Complications of 2,711 vasectomies. J. Urol., 111: 365, 1974. 3. Hackett, R. E. and Waterhouse, K.: Vasectomy-reviewed. Amer. J. Obst. Gynec., 116: 438, 1973. 4. Squires, J. W., Barb, M. W. and Pinch, L. W.: The morbidity of vasectomy. Surg., Gynec. & Obst., 143: 237, 1976. 5. Schmidt, S. S.: Techniques and complications of elective vasectomy. The role of spermatic granuloma in spontaneous recanalization. Fertil. Steril., 17: 467, 1966. 6. Gould, R. S.: Vasectomy-discomfort and complications in 1100 patients studied: the role of steroids in the prevention of swefong and discomfort. J. Urol., 112: 224, 1974. 7. Royer, G. L., Seckman, C. E. and Welshman, I. R.: Safety profile: fifteen years of clinical experience with ibuprofen. Amer. J. Med., suppl. lA, 77: 25, 1984. 8. Kantor, T. G.: Ibuprofen-past, present and future. Amer. J. Med., suppl. lA, 77: 121, 1984. 9. Kantor, T. G.: Ibuprofen. Ann. Intern. Med., 91: 877, 1979. 10. Silber, S. J.: Epididymal extravasation following vasectomy as a cause for failure of vasectomy reversal. Fertil. Steril., 31: 309, 1979. 11. Errey, B. B. and Edwards, I. S.: Open-ended vasectomy: an assessment. Fertil. Steril., 45: 843, 1986. 12. Goodwin, J. S.: Mechanisms of action of nonsteroidal anti-inflammatory agents. Amer. J. Med., suppl. lA, 77: 57, 1984.
THE JOURNAL OF UROLOGY
Printed in U.S.A.
Copyright© 1988 by The Williams & Wilkins Co.
TRIAL OF IBUPROFEN TO PREVENT POST-VASECTOMY COMPLICATIONS ALAN L. MANSON* From the Department of Urology, Naval Hospital, Great Lakes, Illinois
ABSTRACT
Sperm granuloma and epididymitis remain 2 of the most common and incapacitating complications of vasectomy. A study was designed to evaluate the possibility of reducing these inflammatory complications with a prophylactic course of a nonsteroidal anti-inflammatory drug. Patients undergoing outpatient vasectomy were randomized into 2 groups. Group 1 received a prophylactic course of ibuprofen and group 2 received no medication. The ibuprofen was tolerated well and no adverse reactions were noted. There was no increase in postoperative bleeding or hematoma formation. There was no clinical benefit or decrease in complication rate in the ibuprofen-treated group. (J. Ural., 139: 965-966, 1988) Vasectomy is one of the most common urological procedures, with an estimated 750,000 performed in 1971.1 It is considered safe, well tolerated and technically simple means of elective sterilization. Significant complications are rare and consist of hematoma, sperm granuloma, wound infection, abscess, epididand recanalization. 1-• Attempts to decrease postoperative discomfort and lower the complication rate have included changes in technique,2· 5 trials of steroid injection or prophylactic antibiotics. 6 Nonsteroidal anti-inflammatory drugs recently have been extensively studied. One of the safest and most widely studied of these drugs is ibuprofen, which currently is being tested for postoperative pain, arthritis, dysmenorrhea, postoperative per, itoneal adhesions and as an adjunct for vascular surgery or after myocardial infarction. 7• 8 It is relatively inexpensive and it usually is tolerated better than aspirin or other nonsteroidal anti-inflammatory drugs. 7 ' 9 The potential use of ibuprofen after vasectomy is examined in an effort to decrease inflammatory complications (sperm granuloma and epididymitis). METHODS AND MATERIALS
Between July 1986 and May 1987, 102 men 25 to 46 years old underwent vasectomy with the patient under local anesthesia in an outpatient setting. Through bilateral scrotal incision the vasa deferentia were isolated and a 2 cm. segment of each was excised. Both proximal and distal transected ends of the vasa were electrofulgurated and then ligated with chromic sutures. Hemostasis was ensured and the wounds were closed with chromic sutures. A sterile compressive scrotal dressing was applied. The patients were alternately selected randomly into 2 groups. Group 1 received a 7-day course of 800 mg. ibuprofen 3 times daily and group 2 was given no medication. Contraindications to inclusion in this study included a history of coagulation abnormalities, peptic ulcer disease, gastrointestinal bleeding, renal disease or previous hypersensitivity. All patients were instructed to remain at bed rest for the remainder of that and to apply an ice pack. patients returned in 2 weeks for followup. They also were instructed to return at any time for increasing pain, swelling or signs of infection. During this examination specific attention was directed to the possible presence of a hematoma, early
granuloma, epididymitis or infection. After this appointment the patients were told again to return to the clinic at any time for any subsequent problems. A semen analysis was obtained at 6 to 8 weeks. A sperm granuloma was defined as a firm, tender nodule at the vasectomy site. Epididymitis was identified by localized epididymal tenderness, edema and induration. RESULTS
Of the 102 men studied 95 (93.l per cent) returned for the followup examination: 46 were in group 1 (ibuprofen) and 49 were in group 2 (no medication). Although it may be presumed that the patients who did not return for the scheduled followup were free of significant complication, they were excluded from the study. Minimal scrotal edema, ecchymosis and discomfort were considered expected insignificant findings and, therefore, they were excluded from the list of complications. Significant postoperative complications included hematoma, sperm granuloma and epididymitis. There were no wound infections or scrotal abscesses. All hematomas were considered small (less than 3 cm.) and none required drainage. The cases of epididymitis resolved with scrotal elevation and support, bed rest, sitz baths and anti-inflammatory drugs (if the patient currently was not on ibuprofen). Although most episodes of epididymitis are presumed to be related to passive congestion with inflammation secondary to mucosa! separation and extravasation of sperm, infectious etiologies cannot be excluded entirely and, thus, all patients also were treated with a 10-day course of antibiotics. No patients suffered any reactions or complications while on the ibuprofen. There was no increase in postoperative bleeding or hematoma formation. Complications occurred in 8.4 per cent of the patients. There was no statistically significant difference in the total complication rate or individual complications between groups 1 and 2 (see table).
Incidence of complications in patients on ibuprofen (group 1) and those given no medication (group 2)
No. pts. Complication: Hematoma Sperm granuloma Epididymitis Totals
Accepted for publication August 18, 1987. The views expressed herein are those of the author and do not necessarily reflect the views of the United States Navy or the Department of Defense. * Current address: Department of Urology, Naval Hospital, Oakland, California 94627. 965
Group 1 No.(%)
Group 2 No.(%)
Total No.(%)
46
49
95
1 1 3 5
(2.2) (2.2) (6.5) (10.9)
1 (2.0) 2 (4.1) 0 3 (6.1)
2 3 3 8
(2.1) (3.2) (3.2) (8.5)
966
MANSON DISCUSSION
Complications from vasectomy generally are considered to be uncommon and relatively minor in nature. However, owing to the large number of these procedures performed each year, these complications assume more clinical importance. Mild scrotal edema, bruising and minimal discomfort are noted commonly and they are rarely of clinical significance. 2 • 6 More troublesome complications include hematoma, infection, sperm granuloma, epididymitis and recanalization. Leader and associates extensively reviewed the literature and reported incidences of epididymitis of 0.4 to 6.1 per cent, scrotal abscess 5.5 per cent, failure O to 6.0 per cent, sperm granuloma 4.9 to 10.0 per cent, cellulitis 1.5 per cent and hematoma O to 18.2 per cent. 2 Our complication rates certainly were within these limits (epididymitis 3.2 per cent, sperm granuloma 3.2 per cent, infection O per cent and hematoma 2.1 per cent). The incidence of certain complications (hematoma, infection and perhaps sperm granuloma) may be decreased with attention to strict aseptic conditions, meticulous hemostasis, use of modern surgical technique and a compressive scrotal dressing. Further attempts to decrease post-vasectomy complications have included trials of steroids and prophylactic antibiotics. 6 However, since post-vasectomy epididymitis and sperm granuloma are inflammatory in character and only rarely infectious in nature, prophylactic antibiotics would not appear to be indicated. Steroid therapy would be expected to modify or blunt postoperative inflammation. However, steroids generally are considered therapeutic overkill. Sperm granuloma and epididymitis represent 2 of the most common and incapacitating post-vasectomy complications. Sperm granulomas are believed to result from a focal intense granulomatous inflammatory response to extravasated sperm by the perivasal tissues. Some reports indicated that perhaps technical details may be modified to decrease the incidence of this condition. 6 Epididymitis is believed to result from obstructive engorgement or congestion with associated pain and swelling, and disruption of the epididymal tubules with secondary focal small sperm granulomas. 10 Although it has been reported that the open-ended vasectomy technique may decrease the incidence of epididymitis, 11 there still is some concern that it also may be associated with an increased risk of sperm granuloma or recanalization. This study was intended to define a potential role for nonsteroidal anti-inflammatory drugs to prevent or decrease the incidence of post-vasectomy inflammatory conditions (epididymitis and sperm granulomas) without increasing postoperative bleeding or hematoma formation. Such drugs currently are
being tested in a variety of inflammatory conditions with promising results. The current concept of their action is that they inhibit cyclo-oxygenase, which is an enzyme necessary to produce certain prostaglandins (prostaglandin E2 and prosta glandin F2) that are potent mediators of inflammation. 12 They also interfere with leukocyte migration and probably with leukocyte function. One of the most extensively studied and least toxic of the nonsteroidal anti-inflammatory drugs is ibuprofen. 7- 9 Jbuprofen is a well tolerated and inexpensive drug that is readily available and has been shown to have less gastric irritability than aspirin or other nonsteroidal anti-inflammatory drugs. Our study demonstrated that ibuprofen was tolerated well and no adverse reactions to the medication were noted. In addition there was no increase in postoperative bleeding or hematoma 'formation. Unfortunately, there also was no obvious benefit or reduction in complication rates with this regimen. Its use for prophylaxis after vasectomy cannot be recommended I,
•
Dr. Donald Kidd contributed to this study.
REFERENCES
1. Esho, J. 0., Cass, A. S. and Ireland, G. W.: Morbidity associated with vasectomy. J. Urol., 110: 413, 1973. 2. Leader, A. J., Axelrad, S. D., Frankowski, R. and Mumford, S. D.: Complications of 2,711 vasectomies. J. Urol., 111: 365, 1974. 3. Hackett, R. E. and Waterhouse, K.: Vasectomy-reviewed. Amer. J. Obst. Gynec., 116: 438, 1973. 4. Squires, J. W., Barb, M. W. and Pinch, L. W.: The morbidity of vasectomy. Surg., Gynec. & Obst., 143: 237, 1976. 5. Schmidt, S. S.: Techniques and complications of elective vasectomy. The role of spermatic granuloma in spontaneous recanalization. Fertil. Steril., 17: 467, 1966. 6. Gould, R. S.: Vasectomy-discomfort and complications in 1100 patients studied: the role of steroids in the prevention of swefong and discomfort. J. Urol., 112: 224, 1974. 7. Royer, G. L., Seckman, C. E. and Welshman, I. R.: Safety profile: fifteen years of clinical experience with ibuprofen. Amer. J. Med., suppl. lA, 77: 25, 1984. 8. Kantor, T. G.: Ibuprofen-past, present and future. Amer. J. Med., suppl. lA, 77: 121, 1984. 9. Kantor, T. G.: Ibuprofen. Ann. Intern. Med., 91: 877, 1979. 10. Silber, S. J.: Epididymal extravasation following vasectomy as a cause for failure of vasectomy reversal. Fertil. Steril., 31: 309, 1979. 11. Errey, B. B. and Edwards, I. S.: Open-ended vasectomy: an assessment. Fertil. Steril., 45: 843, 1986. 12. Goodwin, J. S.: Mechanisms of action of nonsteroidal anti-inflammatory agents. Amer. J. Med., suppl. lA, 77: 57, 1984.