Current Development
Pelvic denervation for chronic pain associated with endometriosis: Fact or fancy? Paolo Vercellini, MD, Luigi Fedele, MD, Stefano Bianchi, MD, and Giovanni Battista Candiani, MD
Milan, Italy The efficacy of presacral neurectomy and amputation of the uterosacral ligaments in the treatment of chronic pelvic pain has been debated for decades. These procedures used to be done mainly in women with normal pelves, but more recently they have been performed during conservative surgery for treatment of endometriosis. In the 1980s the rapid spread of laparoscopic surgery has led to an increasing number of endoscopic denervations in patients with chronic pelvic pain associated with endometriosis. However, an analysis of literature data has failed to prove that presacral neurectomy and amputation of the uterosacral ligaments are effective and did not demonstrate better results with the use of lasers rather than electrocoagulation. Moreover, no valid comparison has yet been made between laparotomy and laparoscopic methods. (AM J OBSTET GVNECOL 1991 ;165:745-9.)
Key words: Pelvic pain, dysmenorrhea, dyspareunia, endometriosis, presacral neurectomy Chronic pelvic pain is frequently associated with endometriosis.'- 3 Most studies on conservative treatment of this disease have considered the results mainly in terms of fertility, and the most effective management of pain symptoms in women wanting children is still a matter of debate. In 1899 the Italian Ruggi4 and the Frenchman Jaboulay' published the first descriptions of presacral nerve resection in women with severe dysmenorrhea. During the first half of this century presacral neurectomy was performed increasingly in both Europe" and the United States. 7- 9 In the 1950s Doyle lO demonstrated the efficacy of paracervical denervation for the relief of dysmenorrhea by abdominal or vaginal transection of uterosacral ligaments. Until then, pain in women with normal pelves had rarely been differentiated from pain associated with pathologic conditions such as chronic pelvic inflammatory disease or endometriosis. The advent of nonsteroidal antiinflammatory drugs allowed effective treatment of most women with "essential" dysmenorrhea. Consequently, during the 1960s and 1970s there was a fall in the number of pelvic
denervations, which were performed mainly during conservative surgery for severe pelvic endometriosis. During the 1980s it gradually became clear that the possibilities of medical "cure" for endometriosis were limited ll, 12 and interest in pelvic denervation underwent a corresponding resurgence, enhanced by the progressive widespread use of operative endoscopy performed with high-tech methods. '3 Different views have alternated with various generations of surgeons, but the basic problem is still unresolved: Does the performance of pelvic denervation in addition to the standard excision of ovarian and peritoneal lesions significantly increase the well-being of patients with endometriosis or only increase the risk of intraoperative and postoperative morbidity? We have analyzed the recent literature data in an attempt to clarify the usefulness of presacral neurectomy and amputation of the uterosacral ligaments in women with chronic pelvic pain associated with endometriosis, comparing the pain relief obtained by classic and endoscopic surgery.
Pelvic denervation at laparotomy From the Center for the Study and Treatment of Endometriosis, Department of Obstetrics and Gynecology, "L. Mangiagalli," University of Milano School of Medicine. Reprint requests: Paolo Vercellini, MD, Department of Obstetrics and Gynecology "L. Mangiagalli," University of Milano School of Medicine, Via Commenda 12, 20122 Milano, Ital~.
6/]/30673
.
Few clinical studies have been designed to evaluate the efficacy of conservative laparotomy for endometriosis specifically in terms of pain relief (Table 1). Furthermore, the disease stage has not always been specified.
745
746
September 1991 Am J Obstet Gynecol
Vercellini et al.
Table I. Pelvic denervation for chronic pain associated with endometriosis: Effects on symptoms according to literature Dysmenonhea Treatment
Series
Garcia and David,14 1977 Puolakka et al. 15 1980 Polan and DeCherney,16*
1980
Lee et alY* 1986 Tjaden et aJ.l8 1990 Feste,19 1985 Davis,20 1986 Daniell,21 1989 Sutton and HiII,22 1990 Perez,23 1990
CSEL CSEL CSEL CSEL CSEL CSEL CSEL CSEL CSEL CSEL
+ PSN + PSN + PSN + PSN + PSN + USLR + PSN
LPS + carbon dioxide laser + USLR LPS + carbon dioxide laser + USLR LPS + KTP laser + USLR LPS + carbon dioxide laser + USLR LPS + carbon dioxide and Nd :YAG laser + USLR
Dyspareunia
I
I
No. with, % Experiencing No. with % Experiencing symptoms relief symptoms relief
35 36 51 45 20 19 19 21 17 9
97 72 90 80 70 26 79 67 88 0
32
72
NR
146
92
109
80
75
NR
Observational
187
70
NR
Observational
25
80
NR
Observational
26 34
NR NR NR NR
15 19 11 5
74 39
Type of study
87 68 55 60
94
Retrospective, non randomized Retrospective, non randomized Retrospective, nonrandomized Retrospective, nonrandomized Prospective, partly randomized Observational Observational
CSEL, Conservative surgery for endometriosis at laparotomy; PSN, presacral neurectomy; NR, not reported; USLR, uterosacral ligament resection; LPS, laparoscopy; KTP, potassium-titanium-phosphorus; Nd:YAG, neodymium:yttrium-aluminum-garnet. *Mixed pelvic disease.
Garcia and David l4 performed a retrospective analysis of postoperative pain symptoms in 71 patients who underwent conservative surgery for endometriosis and found that in the 35 women who underwent presacral neurectomy dysmenorrhea and dyspareunia decreased significantly with respect to the 36 controls (97% vs 72% and 74% vs 58%). In another retrospective study Puolakka et al. 15 compared 45 women undergoing simple resection of endometriotic lesions with 51 in whom presacral neurectomy also was performed. Pain symptoms resolved or were markedly attenuated in 80% of the former and 90% of the latter. Although the authors considered a 10% difference to be of importance, it does not seem statistically significant. In Polan and DeCherney's study l6 the combination of presacral neurectomy with conservative surgery in women with chronic pelvic pain, endometriosis, or pelvic inflammatory disease increased the percentage of total postoperative pain relief from 26% to 75%, but the mixed pelvic disorders and the small number of patients studied make it difficult to draw conclusions. Lee et al. 17 performed presacral neurectomy in 50 women with chronic pelvic pain, and dysmenorrhea resolved in 73% of the cases, dyspareunia lessened in 77%, and acyclic pain showed improvement in 63%. The uterosacral ligaments were resected in half of the subjects in the study, but this did not improve the pain relief rates. Again no definitive conclusions can be
based on this study because of the inclusion of mixed pelvic disorders. Recently, Tjaden et al. 18 published the combined results of a randomized study and a comparative nonrandomized study performed in patients with moderate or severe endometriosis and chronic pelvic pain who underwent conservative surgery with or without presacral neurectomy. These authors divided dysmenorrhea into midline and lateral categories on the basis of the differences in sensory innervation and observed that midline pain was abolished in all four patients randomized to neurectomy versus none of the four controls who underwent only resection of pelvic endometriotic lesions. These data, together with similar findings in a group of 18 nonrandomized women, led the monitoring committee to stop the study because "it was considered unethical to continue to deprive patients with midline dysmenorrhea of the benefit of pain relief that could be afforded with presacral neurectomy." Somewhat surprisingly, there was no difference between cases and controls in relief of dyspareunia. Because of numerous biases in the design of most of the studies, constructive comments cannot be made on laparotomy for treatment of pelvic pain in patients with endometriosis. Almost all the reports are retrospective and observational without a randomized control group, the extent of endometriosis is rarely indicated, sometime different pelvic diseases are accumulated (such as
Volume 165 Number 3
endometriosis and pelvic inflammatory disease), the sample sizes are limited, the follow-ups are variable, and an objective evaluation of the pain symptoms on the basis of a multidimensional verbal score and! or a visual analogue pain scale 24 . 25 has almost never been performed prospectively. Recently, amputation of the uterosacral ligaments was considered in a report l7 in which the authors observed similar results in women who underwent neurectomy regardless of whether the uterosacral ligaments were or were not resected. Thus whether similar pain relief is achieved by resection of the uterosacral ligaments alone and by presacral neurectomy is still an open question. This could be interesting since in women with endometriosis the uterosacral ligaments may constitute a specific source of disabling pain. 26. 27 Furthermore, resection of the uterosacral ligaments at laparotomy is simple and safe, once the ureters are identified. 28. 29 Presacral neurectomy may result in morbidity, including severe bleeding,'7.30 and constipation." In the absence of verified advantages this operation could be limited to patients in whom identification of the uterosacral ligaments is difficult because of extensive endometriosis of the pouch of Douglas. Tjaden et al. 18 concluded that when the results of neurectomy are unsatisfactory, resection was incomplete or selection of the patients was inappropriate. On this last point Slocumb32 has recently written that" ... the success of presacral neurectomy reported in the literature is not consistent with the general clinical impression of obi gyn practitioner and teaching faculty ... in chronic pelvic pain patients, the localization of pain in terms of tender tissues rarely is limited to the uterosacrals and uterus alone. Many of these other areas not only are outside the areas of presacral innervation, but also are more amenable to other methods of pain treatment." Pelvic de nervation at laparoscopy
Almost all authors who have reported the results of laparoscopic neurotomy in women with endometriosis have not classified the extent of the disease or have given cumulative results for all stages (Table I). Furthermore, as Sutton" observed, most published series "suffer from the disadvantage that they are entirely retrospective and uncontrolled and sceptics can quite reasonably argue that there is a massive placebo effect with this kind of symptom, especially if it is treated with the sort of high-tech wizardry that is implicit in laser beam procedures." Feste l9 reported the resolution or marked improvement of dysmenorrhea in 72% of 32 women with endometriosis and chronic pelvic pain after excision of the implants and resection of the uterosacral ligaments by carbon dioxide laser. In 22% of the cases the symptoms did not change and in 6% they worsened. Using
Denervation for pelvic pain
747
a similar technique, after 15 months of follow-up Davis 20 observed a considerable improvement in dysmenorrhea in 135 of 146 women (92%) and in dyspareunia in 103 of 109 women (94%) with endometriosis without significant differences in relation to the revised American Fertility Society classification stages. 34 An improvement of dysmenorrhea was observed by DanielF l in 75% of 80 patients with endometriosis 6 months after laparoscopic resection of the uterosacral ligaments performed with the potassium-titaniumphosphorus laser fiber. Sutton and HilF2 used a carbon dioxide laser to section uterosacral ligaments and· reported pain resolution in 70% of 187 women with endometriosis, dysmenorrhea, and dyspareunia after a variable follow-up of 1 to 6 years. Lichten and Bombard35 have performed the only randomized, prospective, double-blind study designed to evaluate the efficacy oflaparoscopic uterine nerve ablation by means of bipolar cautery and scissors transection. Unfortunately the presence of endometriosis was one of the exclusion criteria, but the trial is interesting for the objective evaluation of the potential pain relief afforded by the method. A relatively homogeneous group of women were selected who had severe or incapacitating dysmenorrhea and no demonstrable pelvic abnormality at laparoscopy and who were unresponsive to nonsteroidal antiinflammatory drugs and oral contraceptives prescribed concurrently. Coexisting psychiatric illness was evaluated with the Minnesota Multiphasic Personality Inventory, and those with an abnormal psychologic profile were excluded from the study. The remaining 21 patients were randomized to the group undergoing laparoscopic uterine nerve ablation or to the control group at the time of the diagnostic laparoscopy. Neither the patient nor the clinical psychologist who conducted the interview at follow-up was aware of the group to which the patient had been randomized. None of the patients in the control group reported relief from dysmenorrhea whereas 9 of the 11 patients (81 %) who had laparoscopic uterine nerve ablation reported almost complete relief at 3 months and 5 of them had continued relief from dysmenorrhea 1 year after surgery. Evaluation of pain symptoms only 3 months after treatment is not very reliable,36 whereas at 1 year after the operation only 45% of the women continued to report relief from dysmenorrhea. Endometriosis rarely provokes exclusively midline pelvic pain that can definitely be lessened by paracervical or presacral denervation. 37 According to DanielJ,2l "It is important to counsel the patients with endometriosis and chronic pelvic pain carefully preoperatively and make certain that they are aware that success is not guaranteed in all cases." The uncertainties surrounding laparoscopic uterine nerve ablation were eloquently commented on by Vancaillie and Schenken38 : "As with
748
Vercellini et al.
presacral neurectomy, the value of endoscopic neurotomy in relieving pain symptoms has not been established. Further, the complications of this procedure are unknown, but potentially great, because of the proximity of the ureter, rectosigmoid, and uterine vessels." Very few judgments may be expressed on laparoscopic presacral neurectomy because only one observational report has been published to date. 23 After operation, among 25 patients, one required laparotomy because of retroperitoneal bleeding, four continued to experience the original adnexal discomfort, and two underwent subsequent hysterectomy with bilateral salpingo-oophorectomy because of failure to respond to conservative management. Only further studies will clarify whether presacral neurectomy is less risky at laparoscopy than at laparotomy or if it should be enumerated among the many operations that may be done "differently."39
Comment The validity of all evaluative studies of any therapeutic procedures depends on the level of certainty that exists on what would have happened without it. T. Tulandi and N. Cherry40 1989 Conservative surgery for treatment of endometriosis should undergo a rigorous and comprehensive reexamination regarding pain resolution. Most women with endometriosis report both lateral and midline pain. It has not been definitively demonstrated that presacral neurectomy, resection of the uterosacral ligaments, or both, which affect only the midline component, offer significantly better advantages than simple resection of the lesions as far as the general well-being of the women is concerned. Severe complications may follow presacral neurectomy, 17,30 and this procedure should probably be performed in highly selected cases rather than in all women undergoing conservative surgery for treatment of endometriosis. The proposed laparoscopic technique 23 does not seem to reduce the risks and is probably untimely with respect to the current uncertainties on the real indications for the operation. Similar considerations also are relevant to paracervical denervation. DanielF l has recently written, "There have been at least two deaths in North America resulting from bleeding from uterosacral ligaments that occurred when these were transected with CO 2 laser energy. To date neither of these case reports have been published." Accepting without question a fixed chain of events-chronic pelvic pain, endometriosis, and neurectomy (presacral or paracervical)-may create unfounded therapeutic expectations. The mere presence of pelvic endometriosis may not cause symptoms!1 Endometriosis has been found in 15% of pain-free women undergoing laparoscopic tubal sterilization.'" Even when the uterus is believed to be the cause of
September 1991 Am J Obstet Gynecol
chronic pelvic pain, hysterectomy does not improve symptoms in one woman out of four!3 A multidisciplinary approach to evaluate thoroughly the psychic, neurologic, intestinal, and orthopedic components of the reported symptoms has been suggested 44 • 45 and may be proposed to patients before surgery is performed for relief of pelvic pain presumed to be of endometriotic origin. However, even in women with true endometriotic pain, the large area over which lesions are often distributed on the peritoneum and pelvic organs must not be forgotten. 37 . 46 As advised by other authors, 18 a multicenter trial in which the eligibility criteria and surgical procedures are precisely described and carefully monitored would be opportune. So far, there are inadequate data to confirm or refute the effectiveness of presacral neurectomy and amputation of the uterosacral ligaments in the treatment of chronic pelvic pain associated with endometriosis. A last comment concerns the instruments to be used in laparotomy and laparoscopic denervation. Soderstrom 47 maintains that, however delivered, "a watt is a watt," and that to date the clinical studies touting the benefits of laser over electrosurgery have not been convincing. Leaving aside the theoretic advantages that still have not been definitely proved, laser treatment, especially if endoscopic, is fashionable to the extent of figuring in the most widely circulated international magazines 4s •so that show laparoscopists armed with lasers proclaiming that "In 20 years, major abdominal surgery will be nearly extinct."so In the meantime the "traditional" surgeon can console himself with the words of Illingworth sl : "That which is most up to date and new is not necessarily the best." We are pleased to acknowledge the editorial assistance contributed by Alix Green and Luca Vercellini.
REFERENCES I. Guzinski GM, Bonica]], McDonald]S. Gynecologic pain.
In BonicaJJ, Loeser ]D, Chapman CR, Fordyce WE, eds. The management of pain. 2nd ed. Malvern: Lea & Febiger, 1990: 1344-67. 2._ Vercellini P, Fedele L, Arcaini L, Bianchi S, Rognoni MT, Candiani GB. Laparoscopy in the diagnosis of chronic pelvic pain in adolescent women. ] Reprod Med 1989;34:827-30. 3. VerceIlini P, Fedele L, Molteni P, Arcaini L, Bianchi S, Candiani GB. Laparoscopy in the diagnosis of gynecologic chronic pelvic pain. Int ] Gynaecol Obstet 1990; 32:261-7. 4. Ruggi C. La simpatectomia addominale utero-ovarica come mezzo di cura di alcune lesioni interne degli organi genitali della donna. Bologna: Zanichelli, 1899. 5. ]aboulay M. Le traitement de la nevralgie pelvienne par la paralysie du sympathique sacre. Lyon Med 1899; 90:102-8. 6. Cotte G. La sympathectomie hypogastrique: A-t-elle sa place dans la therapeutique gynecologique? Presse Med 1925;33:98-102. 7. Counseller VS, Craig WM. The treatment of dysmenorrhea by resection of the presacral sympathetic nerves:
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8. 9. 10. 11 .
12.
13. 14. 15. 16. 17. 18. 19. 20. 21 . 22. 23. 24.
25.
26. 27. 28.
evaluation of end-results. AM ] OBSTET GYNECOL 1934;28:161-70. Tucker AW Jr, Mass N. An evaluation of presacral neurectomy in the treatment of dysmenorrhea. AM] OBSTET GYNECOL 1947;53:226-32. Ingersoll FM, Meigs ]Y. Presacral neurectomy for dysmenorrhea. N Engl] Med 1948 ;238:357-50. DoyleJB. Paracervical uterine denervation by transection of the cervical plexus for the relief of dysmenorrhea. AM ] OBSTET GYNECOL 1955;70:1 - 15. Candiani GB, Vercellini P, Fedele L, Nava S, Fontana PE. Medical treatment of mild endometriosis associated with infertility. Eur J Obstet Gynecol Reprod BioI 1990;38: 16980. Candiani GB, Vercellini P, Fedele L, Bocciolone L, Bianchi C. Medical treatment of mild endometriosis in infertile women: analysis of a failure. Hum Reprod 1990; 5:901-5. Wheeler JM, Malinak LR. The surgical management of endometriosis. Obstet Gynecol Clin North Am 1989;16:147-56. Garcia CR, David SS. Pelvic endometriosis: infertility and pelvic pain. AM J OBSTET GYNECOL 1977 ;129:740-7. Puolakka J , Kauppila A, Ronnberg L. Results in the operative treatment of pelvic endometriosis. Acta Obstet Gynecol Scand 1980;59:429-31. Polan ML, DeCherney A. Presacral neurectomy for pelvic pain in infertility. Ferti! Steril 1980;34:557-60. Lee RB, Stone K, Magelssen D, Belts RP, Benson WL. Presacral neurectomy for chronic pelvic pain. Obstet Gynecol 1986;69:517-21. Tjaden B, Schlaff WS, Kinball A, Rock JA. The efficacy of presacral neurectomy for the relief of midline dysmenorrhea. Obstet Gynecol 1990;76:89-91. Feste JR. Laser laparoscopy: a new modality. J Reprod Med 1985;30:4 13-7. Davis GD. Management of endometriosis and its associated adhesions with the CO. laser laparoscope. Obstet Gynecol 1986;68:422-5. Daniell ]F. Fiberoptic laser laparoscopy. Baillieres C1in Obstet Gynaecol 1989;3:545-62. Sutton C, Hill D. Laser laparoscopy in the treatment of endometriosis. Br J Obstet Gynaecol 1990;97:181-5. Perez JJ. Laparoscopic presacral neurectomy. ] Reprod Med 1990;35:625-30. Chapman CR, Syrjala KL. Measurement of pain. In Bonica JJ, Loeser JD, Chapman CR, Fordyce WE, eds. T he management of pain . 2nd ed. Malvern: Lea & Febiger, 1990:580-94. Fedele L, Arcaini L, Bianchi S, Baglioni A, Vercellini P. Com parison of cyproterone acetate and danazol in the treatment of pelvic pain associated with endometriosis. Obstet Gynecol 1989;73 :1000-4. Hasson HM. Classification for endometriosis. Fertil Steril 1981;35:368-9. Nesbitt REL Jr, Rizk PT. Uterosacral ligament syndrome. Obstet Gynecol 1971;37:730-3. Buttram VC Jr. Surgical treatment of endometriosis in the infertile female : a modified approach. Fertil Steril 1979;32:635-40.
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29. Malinak LR. Operative management of pelvic pain. Clin Obstet GynecoI1980;23: 191-200. 30. Patsner B, Ozz WJ. Intractable venous sacral hemorrhage: use of stainless steel thumbtacks to obtain hemostasis. AM ] OBSTET GYNECOL 1990;162:452 . 31. Buttram VC Jr, Reiter RC. Endometriosis. In: Buttram VC ]r, Reiter RC, eds. Surgical treatment of the infertile female. Baltimore: Williams & Wilkins, 1985:89-147. 32. Slocumb]C. Operative management of chronic abdominal pelvic pain . Clin Obstet Gynecol 1990;33: 196-204. 33. Sutton C. CO 2 laparoscopy in the treatment of endometriosis. Baillieres Clin Obstet Gynaecol 1989;3:499-523. 34. The American Fertility Society classification of endometriosis: 1985. Fertil Steril 1985;43:35 1-2. 35. Lichten EM, Bombard]. Surgical treatment of primary dysmenorrhea with laparoscopic uterine nerve ablation . ] Reprod Med 1987;32 :37-41. 36. Fedele L, Marchini M, Acaia B, Garagiola U, Tiengo M. Dynamics and significance of placebo response in primary dysmenorrhea. Pain 1989;36:43-7 . 37. Fedele L, Parazzini F, Bianchi S, Arcaini L, Candiani GB . Stage and localization of pelvic endometriosis and pain. Fertil Steril 1990;53: 155-8. 38. Vancaillie T, Schenken RS. Endoscopic surgery. In Schenken RS, ed . Endometriosis. Contemporary concepts in clinical management. Philadelphia: ]B Lippincott, 1989:249-66. 39. DeCherney AH. Anything you can do I can do better ... or differently! Fertil Steril 1987;48:374-6. 40. Tulandi T, Cherry N. Clinical trials in reproductive surgery: randomization and life-table analysis. Ferti! Steril 1989;52: 12-4. 41. Candiani GB, Vercellini P, Fedele L, Colombo A, Candiani M. Mild endometriosis and infertility: a critical review of epidemiologic data, diagnostic pitfalls and classification limits. Obstet Gynecol Surv 1991 [In press). 42. Kresch A], Seifer DB , Sachs LB, Barrese I. Laparoscop y in 100 women with chronic pelvic pain. Obstet Gynecol 1984;64:672-4. 43. Stovall TG, Ling FW, Crawford DA. Hysterectomy for chronic pelvic pain of presumed uterine etiology. Obstet Gynecol 1990;75:676-9. 44. Rapkin A], Kames LD. The pain management approach to chronic pelvic pain.] Reprod Med 1987;32:323-7. 45. Gambone ]C, Reiter RC. Nonsurgical management of chronic pelvic pain: a multidisciplinary approach. Clin Obstet Gynecol 1990;33:205-11. 46. Jenkins S, Olive DL, Haney AF. Endometriosis: pathogenetic implications of the anatomic distribution. Obstet Gynecol 1986;67 :335-8. 47. Soderstrom RM . Electrosurgery: advantages and disadvantages. Prog Clin Bioi Res 1990;323:297-304. 48. Clark M, Carrol G. Conquering endometriosis. Newsweek 1986 Oct 13:97. 49 . Wallis C. The career woman's disease? Time 1986 April 28:50. 50. Cowley G. Hanging up the knife. Newsweek 1990; Feb 12:45-6. 51. Illingworth RS. Why blame the obstetrician? BMJ 1979;1:797-801.
Pelvic denervation for chronic pain associated with endometriosis: Fact or fancy? Paolo Vercellini, MD, Luigi Fedele, MD, Stefano Bianchi, MD, and Giovanni Battista Candiani, MD
Milan, Italy The efficacy of presacral neurectomy and amputation of the uterosacral ligaments in the treatment of chronic pelvic pain has been debated for decades. These procedures used to be done mainly in women with normal pelves, but more recently they have been performed during conservative surgery for treatment of endometriosis. In the 1980s the rapid spread of laparoscopic surgery has led to an increasing number of endoscopic denervations in patients with chronic pelvic pain associated with endometriosis. However, an analysis of literature data has failed to prove that presacral neurectomy and amputation of the uterosacral ligaments are effective and did not demonstrate better results with the use of lasers rather than electrocoagulation. Moreover, no valid comparison has yet been made between laparotomy and laparoscopic methods. (AM J OBSTET GVNECOL 1991 ;165:745-9.)
Key words: Pelvic pain, dysmenorrhea, dyspareunia, endometriosis, presacral neurectomy Chronic pelvic pain is frequently associated with endometriosis.'- 3 Most studies on conservative treatment of this disease have considered the results mainly in terms of fertility, and the most effective management of pain symptoms in women wanting children is still a matter of debate. In 1899 the Italian Ruggi4 and the Frenchman Jaboulay' published the first descriptions of presacral nerve resection in women with severe dysmenorrhea. During the first half of this century presacral neurectomy was performed increasingly in both Europe" and the United States. 7- 9 In the 1950s Doyle lO demonstrated the efficacy of paracervical denervation for the relief of dysmenorrhea by abdominal or vaginal transection of uterosacral ligaments. Until then, pain in women with normal pelves had rarely been differentiated from pain associated with pathologic conditions such as chronic pelvic inflammatory disease or endometriosis. The advent of nonsteroidal antiinflammatory drugs allowed effective treatment of most women with "essential" dysmenorrhea. Consequently, during the 1960s and 1970s there was a fall in the number of pelvic
denervations, which were performed mainly during conservative surgery for severe pelvic endometriosis. During the 1980s it gradually became clear that the possibilities of medical "cure" for endometriosis were limited ll, 12 and interest in pelvic denervation underwent a corresponding resurgence, enhanced by the progressive widespread use of operative endoscopy performed with high-tech methods. '3 Different views have alternated with various generations of surgeons, but the basic problem is still unresolved: Does the performance of pelvic denervation in addition to the standard excision of ovarian and peritoneal lesions significantly increase the well-being of patients with endometriosis or only increase the risk of intraoperative and postoperative morbidity? We have analyzed the recent literature data in an attempt to clarify the usefulness of presacral neurectomy and amputation of the uterosacral ligaments in women with chronic pelvic pain associated with endometriosis, comparing the pain relief obtained by classic and endoscopic surgery.
Pelvic denervation at laparotomy From the Center for the Study and Treatment of Endometriosis, Department of Obstetrics and Gynecology, "L. Mangiagalli," University of Milano School of Medicine. Reprint requests: Paolo Vercellini, MD, Department of Obstetrics and Gynecology "L. Mangiagalli," University of Milano School of Medicine, Via Commenda 12, 20122 Milano, Ital~.
6/]/30673
.
Few clinical studies have been designed to evaluate the efficacy of conservative laparotomy for endometriosis specifically in terms of pain relief (Table 1). Furthermore, the disease stage has not always been specified.
745
746
September 1991 Am J Obstet Gynecol
Vercellini et al.
Table I. Pelvic denervation for chronic pain associated with endometriosis: Effects on symptoms according to literature Dysmenonhea Treatment
Series
Garcia and David,14 1977 Puolakka et al. 15 1980 Polan and DeCherney,16*
1980
Lee et alY* 1986 Tjaden et aJ.l8 1990 Feste,19 1985 Davis,20 1986 Daniell,21 1989 Sutton and HiII,22 1990 Perez,23 1990
CSEL CSEL CSEL CSEL CSEL CSEL CSEL CSEL CSEL CSEL
+ PSN + PSN + PSN + PSN + PSN + USLR + PSN
LPS + carbon dioxide laser + USLR LPS + carbon dioxide laser + USLR LPS + KTP laser + USLR LPS + carbon dioxide laser + USLR LPS + carbon dioxide and Nd :YAG laser + USLR
Dyspareunia
I
I
No. with, % Experiencing No. with % Experiencing symptoms relief symptoms relief
35 36 51 45 20 19 19 21 17 9
97 72 90 80 70 26 79 67 88 0
32
72
NR
146
92
109
80
75
NR
Observational
187
70
NR
Observational
25
80
NR
Observational
26 34
NR NR NR NR
15 19 11 5
74 39
Type of study
87 68 55 60
94
Retrospective, non randomized Retrospective, non randomized Retrospective, nonrandomized Retrospective, nonrandomized Prospective, partly randomized Observational Observational
CSEL, Conservative surgery for endometriosis at laparotomy; PSN, presacral neurectomy; NR, not reported; USLR, uterosacral ligament resection; LPS, laparoscopy; KTP, potassium-titanium-phosphorus; Nd:YAG, neodymium:yttrium-aluminum-garnet. *Mixed pelvic disease.
Garcia and David l4 performed a retrospective analysis of postoperative pain symptoms in 71 patients who underwent conservative surgery for endometriosis and found that in the 35 women who underwent presacral neurectomy dysmenorrhea and dyspareunia decreased significantly with respect to the 36 controls (97% vs 72% and 74% vs 58%). In another retrospective study Puolakka et al. 15 compared 45 women undergoing simple resection of endometriotic lesions with 51 in whom presacral neurectomy also was performed. Pain symptoms resolved or were markedly attenuated in 80% of the former and 90% of the latter. Although the authors considered a 10% difference to be of importance, it does not seem statistically significant. In Polan and DeCherney's study l6 the combination of presacral neurectomy with conservative surgery in women with chronic pelvic pain, endometriosis, or pelvic inflammatory disease increased the percentage of total postoperative pain relief from 26% to 75%, but the mixed pelvic disorders and the small number of patients studied make it difficult to draw conclusions. Lee et al. 17 performed presacral neurectomy in 50 women with chronic pelvic pain, and dysmenorrhea resolved in 73% of the cases, dyspareunia lessened in 77%, and acyclic pain showed improvement in 63%. The uterosacral ligaments were resected in half of the subjects in the study, but this did not improve the pain relief rates. Again no definitive conclusions can be
based on this study because of the inclusion of mixed pelvic disorders. Recently, Tjaden et al. 18 published the combined results of a randomized study and a comparative nonrandomized study performed in patients with moderate or severe endometriosis and chronic pelvic pain who underwent conservative surgery with or without presacral neurectomy. These authors divided dysmenorrhea into midline and lateral categories on the basis of the differences in sensory innervation and observed that midline pain was abolished in all four patients randomized to neurectomy versus none of the four controls who underwent only resection of pelvic endometriotic lesions. These data, together with similar findings in a group of 18 nonrandomized women, led the monitoring committee to stop the study because "it was considered unethical to continue to deprive patients with midline dysmenorrhea of the benefit of pain relief that could be afforded with presacral neurectomy." Somewhat surprisingly, there was no difference between cases and controls in relief of dyspareunia. Because of numerous biases in the design of most of the studies, constructive comments cannot be made on laparotomy for treatment of pelvic pain in patients with endometriosis. Almost all the reports are retrospective and observational without a randomized control group, the extent of endometriosis is rarely indicated, sometime different pelvic diseases are accumulated (such as
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endometriosis and pelvic inflammatory disease), the sample sizes are limited, the follow-ups are variable, and an objective evaluation of the pain symptoms on the basis of a multidimensional verbal score and! or a visual analogue pain scale 24 . 25 has almost never been performed prospectively. Recently, amputation of the uterosacral ligaments was considered in a report l7 in which the authors observed similar results in women who underwent neurectomy regardless of whether the uterosacral ligaments were or were not resected. Thus whether similar pain relief is achieved by resection of the uterosacral ligaments alone and by presacral neurectomy is still an open question. This could be interesting since in women with endometriosis the uterosacral ligaments may constitute a specific source of disabling pain. 26. 27 Furthermore, resection of the uterosacral ligaments at laparotomy is simple and safe, once the ureters are identified. 28. 29 Presacral neurectomy may result in morbidity, including severe bleeding,'7.30 and constipation." In the absence of verified advantages this operation could be limited to patients in whom identification of the uterosacral ligaments is difficult because of extensive endometriosis of the pouch of Douglas. Tjaden et al. 18 concluded that when the results of neurectomy are unsatisfactory, resection was incomplete or selection of the patients was inappropriate. On this last point Slocumb32 has recently written that" ... the success of presacral neurectomy reported in the literature is not consistent with the general clinical impression of obi gyn practitioner and teaching faculty ... in chronic pelvic pain patients, the localization of pain in terms of tender tissues rarely is limited to the uterosacrals and uterus alone. Many of these other areas not only are outside the areas of presacral innervation, but also are more amenable to other methods of pain treatment." Pelvic de nervation at laparoscopy
Almost all authors who have reported the results of laparoscopic neurotomy in women with endometriosis have not classified the extent of the disease or have given cumulative results for all stages (Table I). Furthermore, as Sutton" observed, most published series "suffer from the disadvantage that they are entirely retrospective and uncontrolled and sceptics can quite reasonably argue that there is a massive placebo effect with this kind of symptom, especially if it is treated with the sort of high-tech wizardry that is implicit in laser beam procedures." Feste l9 reported the resolution or marked improvement of dysmenorrhea in 72% of 32 women with endometriosis and chronic pelvic pain after excision of the implants and resection of the uterosacral ligaments by carbon dioxide laser. In 22% of the cases the symptoms did not change and in 6% they worsened. Using
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a similar technique, after 15 months of follow-up Davis 20 observed a considerable improvement in dysmenorrhea in 135 of 146 women (92%) and in dyspareunia in 103 of 109 women (94%) with endometriosis without significant differences in relation to the revised American Fertility Society classification stages. 34 An improvement of dysmenorrhea was observed by DanielF l in 75% of 80 patients with endometriosis 6 months after laparoscopic resection of the uterosacral ligaments performed with the potassium-titaniumphosphorus laser fiber. Sutton and HilF2 used a carbon dioxide laser to section uterosacral ligaments and· reported pain resolution in 70% of 187 women with endometriosis, dysmenorrhea, and dyspareunia after a variable follow-up of 1 to 6 years. Lichten and Bombard35 have performed the only randomized, prospective, double-blind study designed to evaluate the efficacy oflaparoscopic uterine nerve ablation by means of bipolar cautery and scissors transection. Unfortunately the presence of endometriosis was one of the exclusion criteria, but the trial is interesting for the objective evaluation of the potential pain relief afforded by the method. A relatively homogeneous group of women were selected who had severe or incapacitating dysmenorrhea and no demonstrable pelvic abnormality at laparoscopy and who were unresponsive to nonsteroidal antiinflammatory drugs and oral contraceptives prescribed concurrently. Coexisting psychiatric illness was evaluated with the Minnesota Multiphasic Personality Inventory, and those with an abnormal psychologic profile were excluded from the study. The remaining 21 patients were randomized to the group undergoing laparoscopic uterine nerve ablation or to the control group at the time of the diagnostic laparoscopy. Neither the patient nor the clinical psychologist who conducted the interview at follow-up was aware of the group to which the patient had been randomized. None of the patients in the control group reported relief from dysmenorrhea whereas 9 of the 11 patients (81 %) who had laparoscopic uterine nerve ablation reported almost complete relief at 3 months and 5 of them had continued relief from dysmenorrhea 1 year after surgery. Evaluation of pain symptoms only 3 months after treatment is not very reliable,36 whereas at 1 year after the operation only 45% of the women continued to report relief from dysmenorrhea. Endometriosis rarely provokes exclusively midline pelvic pain that can definitely be lessened by paracervical or presacral denervation. 37 According to DanielJ,2l "It is important to counsel the patients with endometriosis and chronic pelvic pain carefully preoperatively and make certain that they are aware that success is not guaranteed in all cases." The uncertainties surrounding laparoscopic uterine nerve ablation were eloquently commented on by Vancaillie and Schenken38 : "As with
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presacral neurectomy, the value of endoscopic neurotomy in relieving pain symptoms has not been established. Further, the complications of this procedure are unknown, but potentially great, because of the proximity of the ureter, rectosigmoid, and uterine vessels." Very few judgments may be expressed on laparoscopic presacral neurectomy because only one observational report has been published to date. 23 After operation, among 25 patients, one required laparotomy because of retroperitoneal bleeding, four continued to experience the original adnexal discomfort, and two underwent subsequent hysterectomy with bilateral salpingo-oophorectomy because of failure to respond to conservative management. Only further studies will clarify whether presacral neurectomy is less risky at laparoscopy than at laparotomy or if it should be enumerated among the many operations that may be done "differently."39
Comment The validity of all evaluative studies of any therapeutic procedures depends on the level of certainty that exists on what would have happened without it. T. Tulandi and N. Cherry40 1989 Conservative surgery for treatment of endometriosis should undergo a rigorous and comprehensive reexamination regarding pain resolution. Most women with endometriosis report both lateral and midline pain. It has not been definitively demonstrated that presacral neurectomy, resection of the uterosacral ligaments, or both, which affect only the midline component, offer significantly better advantages than simple resection of the lesions as far as the general well-being of the women is concerned. Severe complications may follow presacral neurectomy, 17,30 and this procedure should probably be performed in highly selected cases rather than in all women undergoing conservative surgery for treatment of endometriosis. The proposed laparoscopic technique 23 does not seem to reduce the risks and is probably untimely with respect to the current uncertainties on the real indications for the operation. Similar considerations also are relevant to paracervical denervation. DanielF l has recently written, "There have been at least two deaths in North America resulting from bleeding from uterosacral ligaments that occurred when these were transected with CO 2 laser energy. To date neither of these case reports have been published." Accepting without question a fixed chain of events-chronic pelvic pain, endometriosis, and neurectomy (presacral or paracervical)-may create unfounded therapeutic expectations. The mere presence of pelvic endometriosis may not cause symptoms!1 Endometriosis has been found in 15% of pain-free women undergoing laparoscopic tubal sterilization.'" Even when the uterus is believed to be the cause of
September 1991 Am J Obstet Gynecol
chronic pelvic pain, hysterectomy does not improve symptoms in one woman out of four!3 A multidisciplinary approach to evaluate thoroughly the psychic, neurologic, intestinal, and orthopedic components of the reported symptoms has been suggested 44 • 45 and may be proposed to patients before surgery is performed for relief of pelvic pain presumed to be of endometriotic origin. However, even in women with true endometriotic pain, the large area over which lesions are often distributed on the peritoneum and pelvic organs must not be forgotten. 37 . 46 As advised by other authors, 18 a multicenter trial in which the eligibility criteria and surgical procedures are precisely described and carefully monitored would be opportune. So far, there are inadequate data to confirm or refute the effectiveness of presacral neurectomy and amputation of the uterosacral ligaments in the treatment of chronic pelvic pain associated with endometriosis. A last comment concerns the instruments to be used in laparotomy and laparoscopic denervation. Soderstrom 47 maintains that, however delivered, "a watt is a watt," and that to date the clinical studies touting the benefits of laser over electrosurgery have not been convincing. Leaving aside the theoretic advantages that still have not been definitely proved, laser treatment, especially if endoscopic, is fashionable to the extent of figuring in the most widely circulated international magazines 4s •so that show laparoscopists armed with lasers proclaiming that "In 20 years, major abdominal surgery will be nearly extinct."so In the meantime the "traditional" surgeon can console himself with the words of Illingworth sl : "That which is most up to date and new is not necessarily the best." We are pleased to acknowledge the editorial assistance contributed by Alix Green and Luca Vercellini.
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