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Laparoscopic evaluation and treatment of women with chronic pelvic pain
Laparoscopyand Chronic Pelvic Pain Howard
Laparoscopic Evaluation and Treatment of Women With Chronic Pelvic Pain Fred M. Howard, M.D.
Abstract Study Objective. To evaluate the effectiveness of operative laparoscopic treatment at the time of diagnostic laparoscopy in patients with chronic pelvic pain (CPP). Design. A retrospective study of women with CPP and at least 6 months of follow-up after laparoscopic evaluation and treatment. Setting. A faculty practice and community teaching hospital. Patients. A series of 65 consecutive women with greater than 1 month of pelvic pain who underwent laparoscopy. Thirty-two were referred by other physicians for evaluation of CPP. Interventions. Patients had operative laparoscopic treatment of all abnormal findings at the time of diagnostic laparoscopy. Nonspecific treatment such as presacral neurectomy or uterine nerve ablation was not performed. Measurements and Main Results. After laparoscopic evaluation and treatment, 78% of patients had decreased pain and 45% were pain free. Prior unsuccessful medical or surgical treatment did not affect the response rate. Endometriosis and adhesive disease were the roost common diagnoses, 38% and 34%, respectively. Conclusions. Laparoscopic surgical treatment of pathology noted at the time of diagnostic laparoscopy in women with CPP is appropriate, but less than one-half of patients may be expected to have complete pain relief. Procedures undertaken to evaluate women with chronic pelvic pain (CPP) vary widely, but diagnostic laparoscopy is usually performed. A survey of recently published series suggests that 40% of all laparoscopies are done for CPP, and that the figure may actually be increasing. 1 Although this may be due to the prevalence of CPP, it seems more likely attribut-
a b l e to t h e o p i n i o n o f m o s t g y n e c o l o g i s t s t h a t l a p a r o s c o p y is m a n d a t o r y f o r e v a l u a t i n g t h e s e patients. 2 With the rapid development of advanced operative laparoscopy (pelviscopy) over the past 2 decades, laparoscopy has assumed more than just a diagnostic role in CPP. These developments have allowed gyne-
From the Department of Obstetrics and Gynecology, Rochester General Hospital, and the University of Rochester School of Medicine and Dentistry, Rochester, New York. Address reprint requests to Fred M. Howard, M.D., Department of Obstetrics and Gynecology, Rochester General Hospital, 1425 Portland Avenue, Rochester, NY 14621. Presented at the 22rid annual meeting of the American Association of GynecologicLaparoscopists,San Francisco.
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cologists to perform operative laparoscopy in many patients, avoiding the need for l a p a r o t o m y . Pelviscopic treatment often is done at the same time as diagnostic laparoscopy,3 an approach that is common 4.s despite lack of prospective or controlled trials demonstrating its effectiveness. In addition, most published studies of combined diagnostic and operative laparoscopy report results for specific diagnoses (e.g., endometriosis) 6, 7 or specific procedures (e.g., uterosacral nerve ablation) 8 rather than the mixture of diagnoses and treatments the practicing gynecologist usually encounters. Thus, they do not generally address the predicament faced by the gynecologist during preoperative counseling, when the diagnosis is not known and the patient wishes information about her chances that combined diagnostic and operative laparoscopy will cure her pain. The present study was undertaken to address the effectiveness of combined diagnostic and operative laparoscopy in patients with CPP. Materials and Methods Office, operative, and hospital records of all women on whom I performed laparoscopy for CPP from July 1991 to July 1992 were reviewed. Prior to laparoscopy, the patients had thorough evaluations that included at least complete histories and physical examinations, cervical cultures for gonorrhea, cervical smears for Chlamydia, urine cultures, pregnancy testing, Papanicolaou smears, and complete blood cell counts. Sonography was not a preoperative prerequisite, but most patients had transvaginal or transabdominal ultrasound examinations. Women with pain attributed to nongynecologic diagnoses and those responsive to medical therapy did not undergo laparoscopy and are not included in this report. The definition of CPP during this interval was nonmenstrual pain of 1 or more months' duration that was localized to the anatomic pelvis, was severe enough to cause functional disability, and required medical or surgical treatment. The generally accepted duration for CPP is 6 months,9 but a shorter time was allowed in this study to permit evaluation of early diagnostic and operative interventions. All patients were asked to grade their pain subjectively as none, mild, moderate, or severe at all visits, both preoperatively and postoperatively. Numerical severity scores from 3, severe pain, to 0, no pain, were then assigned to allow statistical evaluation. Patients were consid-
326
ered pain free only if they denied pelvic pain (score 0). All women with pain relief after laparoscopy had at least 6 months of follow-up. Those with pain relief but less than 6 months of follow-up were recorded as lost. Follow-up with a referring physician was considered acceptable if records were available and if the visits included patient evaluations of pain intensity. Primary diagnoses were based on a combination of. clinical, o p e r a t i v e , and histologic findings. Endometriosis was diagnosed solely on visual findings only in cases with classic endometriotic lesions, such as black or powder burn lesions. In patients with subtle or atypical lesions, such as red, white, clear, or peritoneal pocket lesions, the diagnosis was made only by histologic c o n f i r m a t i o n . ~° If p r e s e n t , endometriosis was always considered the primary diagnosis. Staging was done at the time of surgery a c c o r d i n g to the revised classification of the American Fertility Society. Adhesions were considered a primary diagnosis only if they involved the pelvic reproductive viscera. Thus, bowel adhesions were not considered diagnostic unless they were adherent to the uterus, fallopian tubes, ovaries, or uterine ligaments. Ovarian cysts, including corpora lutea, were considered as diagnoses if they had been persistent for greater than one menstrual cycle and were consistent with the location of the patient's pelvic pain. u Ovarian remnant syndrome was diagnosed only with histologic confirmation of ovarian tissue after documented prior bilateral oophorectomy.~2 Residual ovary syndrome was diagnosed with adhesions and/or cystic change of retained ovaries after a hysterectomy. ~3 Chronic salpingitis was diagnosed with adhesions and hydrosalpinges of one or both fallopian tubes without evidence of acute infection. 14 Ovarian edema was diagnosed based on visualization of ovarian enlargement and histologic confirmation of marked ovarian edema. 15Leiomyoma, chronic appendicitis, and benign cystic teratoma were diagnosed by histologic confirmation and with locations consistent with the location of pelvic pain. I performed or supervised the laparoscopies of all patients in this study. The cases were assigned 2 hours of operative time to allow combined diagnostic and operative procedures. A multiple-puncture technique (two or more cannula sites) was used in all cases to allow complete pelvic visualization. Operative laparoscopies were performed with a three- or four-puncture technique using a variety of modalities depending on the surgical procedure. An attempt was always
Laparoscopy and Chronic Pelvic Pain Howard
made to reestablish normal pelvic anatomy and to treat all visible abnormalities thought to be potential causes of CPP. Carbon dioxide laser, monopolar and bipolar electrosurgery, and hydrodissection were used to treat endometriosis and adhesions and to perform excisional biopsies. Care was taken to ablate or excise fully all endometriotic lesions and adhesions. Endoscopic loop ligatures, sutures, and bipolar coagulation were used for oophorectomies, myomectomies, salpingectomies, and hysterectomies as surgically indicated. Ovarian cystectomies were performed with a stripping technique without repair of the defect. Peritoneal and ovarian lesions were liberally biopsied for histologic evaluation. Neither uterine nerve ablations nor presacral neurectomies were performed on any of these patients. Adhesion-prevention barriers and endoscopic stapler-cutters were not used. Statistics were calculated using the Epilnfo program version 5 (Centers for Disease Control, Atlanta, GA). Student's t test or Kruskal-Wallis analysis was used to compare means (Kruskal-Wallis if the variances were dissimilar by analysis of variance). Frequencies or distributions were compared by either Z~-or Fischer's exact analysis.
TABLE 1. Pain Characteristics and Associated Symptoms of Women With CPP Characteristic
Number or Mean _+SD
Percentage or Range
Duration of pain (mo) Location of pain Bilateral/midline Left only Right only Dysmenorrhea Dyspareunia Dyspareunia + dysmenorrhea Low back pain Gastrointestinal symptoms Headaches Urinary symptoms
22.7 + 38.1
1-244
23 26 16 35 28 22 11 9 8 3
35.4 40.0 24.6 53.8 43.1 33.8 16.9 13.8 12.3 4.6
Clinical Response After laparoscopic evaluation and treatment, 29 (45%) women were pain free. Mean follow-up in these patients was 10.7 _+3.8 months (range 6-18 mo). Figure 1 shows the postoperative responses for the major clinical diagnoses. The numbers for individual diagnoses are too small to draw any conclusions about comparative response rates. However, patients with the three most frequent diagnoses, endometrio-
Results
Sixty-five women (mean age 31.0 ___6.9 yrs, range 17-52 yrs) underwent laparoscopy for evaluation and treatment of CPP during the 12 months of this study. Their mean parity was 1.7 _+ 1.2 (range 0-5), and 15 (23%) patients were nulliparous (mean duration 11.7_+ 4.2 mo, mean no. of visits 3.2 _+ 1.8, range 0-9 visits). We followed 62 (95%) women for 6 months or longer (range 6-20 mo). Three patients were lost to follow-up before the sixth postoperative month. Thirty (46%) were Medicaid insured and 35 (54%) had private insurance. T h i r t y - t w o (49%) were referred by other physicians specifically for evaluation of CPP. Pain characteristics and associated symptoms are summarized in Table 1.
TABLE 2. Operative Procedures Performed at Time of Laparoscopy Operative Procedures
Number
Adhesiolysis 47 Ovarian cystectomy 25 Excision of endometriosis 21 Diagnostic biopsy 15 Ablation of endometriosis 13 Paratubal cystectomy 9 Bilateral tubal ligation 5 Dilatation & curettage 5 Ovarian cystotomy 4 Oophorectomy 4 Myomectomy 3 Appendectomy 2 Ovarian cystectomy, bilateral 2 Salpingo-oophorectomy 2 Laparoscopic hysterectomy 1 Salpingo-oophorectomy, bilateral 1 Totals 159 Mean number of procedures per patient = 2.4.
Operative Procedures One hundred fifty-nine operative procedures were p e r f o r m e d at the time of the d i a g n o s t i c laparoscopy in these patients (average 2.4 procedures/patient, range 0-4; Table 2). Histology specimens were submitted in 54 of the 65 cases.
327
Percent 72.3 38.5 32.2 23.1 20.0 13.9 7.7 7.7 6.1 6.1 4.6 3.1 3.1 3.1 1.5 1.5 244.6
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311
N
[] Pain-fmei 0 Pain Lost
-F--.--t
26
N
Number 16 10
TOTAL
Endonwbiosis
Adhesions
No diagnosis
All ovarian
Oihers
FIGURE 1. Pain relief after laparoscopic diagnosis and treatment in 65 women with chronic pelvic pain.
sis, adhesions, and ovarian pathology, had similar responses, 44%, 50%, and 38%, respectively. Of the 33 women with continued pain, 22 had persistent pain at their initial postoperative visit. Eleven were initially pain free, but subsequently developed recurrent pain, albeit less severe. In two pain recurred at 1 month, in four at 2 months, and in one each at 3, 5, 8, 12, and 14 months. The frequency of adhesiolysis was not different in those with recurrent pain than in the rest of the population (p = 0.64) or those who remained pain free (p = 0.76). Mean pain severity scores were 2.8 + 0.4 preoperatively and 1.1 + 1.2 postoperatively (p <0.001). Preoperatively, 55 women had severe pain and 10 had moderate pain; 6 of the latter were pain free postoperatively, compared with 23 of the former (p -- 0.32). Only 11 patients, all with severe pain preoperatively, showed no decrease whatsoever in pain level after surgery. Overall, 51 (82%) of the 62 patients with follow-up had decreased pain. The mean duration of pain preoperatively was 15.5 _ 16.1 months in women who were pain free postoperatively, compared with 28.5 + 48.7 months in those with continued pain or lost to follow-up (p -0.063). Five patients had greater than 5 years of CPP, and none of them was pain free postoperatively. Twenty-one women had 1 to 6 months of CPP
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preoperatively, and 44 had 6 or more months. The response to operative treatment in patients in the first group was lower (8/21, 38%) than that in the second (21/44, 48%), but this difference was not statistically significant (p = 0.46). Twenty-seven women had undergone previous unsuccessful surgical treatment for CPP. Of these, 13 (48%) were pain free, 13 (48%) had continued pain, and 1 (4%) was lost to follow-up. Thirty-eight had not had any prior surgical treatment specifically for CPP; 16 (42%) were pain free, 20 (53%) had continued pain, and 2 (5%) were lost. These results were not clinically or statistically different (p = 0.63).
Diagnoses An operative diagnosis was made in 60 (92%) patients. The most frequent primary diagnoses were endometriosis and adhesions, accounting for 38% and 34%, respectively (Table 3). No other individual diagnosis accounted for more than 5% of the total, although the ovarian diagnoses (corpus luteum, residual ovary, ovarian remnant, ovarian edema, cystic teratoma) accounted for 12% of the total (8/65). One additional patient also had ovarian remnant syndrome, but had histologically confirmed endometriosis as well, which was c o n s i d e r e d the p r i m a r y diagnosis.
Laparoscopy and Chronic Pelvic Pain Howard
TABLE 3. Primary LaparoscopicDiagnoses Diagnosis Endometriosis Adhesions No diagnosis Left corpus luteum Chronic salpingitis Residual ovary syndrome Ovarian remnant syndrome Chronic appendicitis Foreign body reaction Ovarian edema Leiomyoma Right cystic teratoma Totals
Number 25 22 5 3 2 2 1 1 1 1 1 1 65
Complications Complications occurred in six patients (9%). Two of these were intraoperative: a rectosigmoid bowel injury during posterior colpotomy, and an epigastric artery laceration. Both were managed laparoscopically without further untoward events. The woman with laparoscopic bowel injury and repair was admitted to the hospital for observation and antibiotic prophylaxis for 3 days. The woman with epigastric artery laceration was discharged on the day of surgery. The four postoperative complications were two pelvic infections, one umbilical wound infection, and one umbilical herniation of omentum. Women with infections were managed on an ambulatory basis. The one with omental herniation underwent operative excision, reclosure of the umbilical incision, and hospital observation for 48 hours? 6 No patients required a laparotomy.
Percent 38.5 33.8 7.7 4.6 3.0 3.0 1.5 1.5 1.5 1.5 1.5 1.5 100.0
Prior Treatment Overall, 55 (85%) women had had some form of unsuccessful treatment for CPP. Forty had undergone abdominopelvic surgery, six of whom had two procedures. Thirty of these procedures, involving 27 patients, were performed specifically for CPP: 9 laparotomies; 15 laparoscopies; and 6 hysterectomies, with removal of both adnexae in 3. Thirteen patients had previously been diagnosed as having endometriosis. The original diagnoses were based only on visual findings in 11 and on histologic findings in 2. Endometriosis was again diagnosed in only 5 (38%) of these 13 women, mild disease in 4 and moderate in 1. Endometriosis was not found in the other eight patients, and instead the laparoscopic diagnoses were adhesions (5), residual ovary syndrome (1), ovarian remnant syndrome (1), and no diagnosis (1). Twenty-five of the 65 women had been diagnosed and treated for pelvic inflammatory disease (PID). However, laparoscopic evidence of chronic salpingitis was found in only five, two of whom had not been previously diagnosed or treated for PID. Chronic salpingitis was the primary operative diagnosis in only two patients, only one of whom had been treated for PID. Seventeen of the 30 Medicaid-insured patients had a history of treatment for PID, compared with only 8 of the 35 privately insured patients (p = 0.005). Of the five women with intraoperative findings consistent with chronic salpingitis, two were insured by Medicaid and three privately.
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Discussion
This study suggests that during preoperative counseling a gynecologist may reasonably tell the patient with CPP that after combined diagnostic and operative laparoscopy she has about a 45% chance that she will be pain free for 6 months or more; a 30% to 35% chance that she will have decreased but continued pain; and a 20% to 25% chance that she will derive no benefit from the procedure. These outcomes appear to be relatively consistent regardless of the diagnosis. In addition, these results are similar to those reported specifically for laparoscopic treatment of endometriosis~7-19and adhesions.2°,21 Endometriosis and adhesions are the two most frequent diagnoses made at laparoscopy for CPP, each accounting for about one-third. Most other studies reported no laparoscopic diagnosis in one-third or more of patients, l, z~,23 However, this series showed a much higher rate of positive findings, with a specific diagnosis made in 9 of 10 women. This higher rate may be due to the fact that patients with pain attributed to nongynecologic diagnoses and those responsive to medical therapy did not undergo laparoscopy and were not included in this study. Also, 15% of the women had ovarian abnormalities thought responsible for pelvic pain, but some of these diagnoses, particularly corpus luteum, benign cystic teratoma, and ovarian edema, are unproved and debatable causes of CPP. Several factors that were expected to affect the
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response to treatment, in fact, did not. About 50% of patients who had had surgery for CPP, including three of six with hysterectomies, were pain free after pelviscopy, which was not significantly different from the response rate of patients who had not had such treatment. Obviously clinical judgment is necessary, but one should not per se assume that if previous surgery was unsuccessful, combined diagnostic and operative laparoscopy has no role. It was previously hypothesized that earlier intervention might either prevent the development of CPP or improve response to treatment. 1 Therefore, the definition of CPP was reevaluated during this study by including patients with less than 6 months of pain. However, no greater improvement in response to treatment was found in these patients than in women with more than 6 months of pain. The results of this study call into question the use of the diagnosis of PID, especially chronic PID. Although 25 women in this series had been treated for PID as an approach to treating CPP, only 3 of them had any evidence of salpingitis at laparoscopy. Furthermore, the preoperative diagnosis of PID was much more common in Medicaid than in privately insured patients. Although this is not proof that the diagnosis was incorrect, this fact lends itself to that interpretation. Certainly, it seems appropriate to suggest that patients with CPP should not be labeled with a diagnosis of PID or chronic PID without objective laparoscopic evidence.24 The presence of chronic pain syndrome was suggested to be a preoperative predictor of poorer response to laparoscopic adhesiolysis.20 Response to treatment was only 40% in women with the syndrome, compared with 75% in those without it. Patients with four or more of the following characteristics are considered to have chronic pain syndrome: duration of pain for 6 or more months; incomplete relief by most previous treatments; significantly impaired function at home or work; signs of depression; pain out of proportion to pathology; and altered family roles. 25 Unfortunately, the design of the present study did not allow evaluation of this syndrome, but two of the characteristics, 6 or more months' duration and incomplete relief with previous therapy, were not supported as being individually predictive of response in this series. Possibly the four psychologic and behavioral characteristics are more significant than are duration of pain and history of prior treatment in defining chronic pain syndrome and in distin-
330
guishing these patients from others with CPP. Although the results of this study are optimistic, two particular points should be made. First, this was a r e t r o s p e c t i v e , u n c o n t r o l l e d r e p o r t of a series. Therefore, it cannot be concluded that combined diagnostic and operative laparoscopy for CPP can be definitively considered efficacious or superior to other modes of treatment. 9, 26 It is worth noting that the pain-free response rate was only 10% higher than the placebo effectiveness of 35.2 _+2.2% in Beecher's classic studies of placebo/7 Also, of five patients in this study with no diagnosis, two were pain free for the duration of follow-up (17 and 19 mo). Second, this was a selected population. All patients underwent thorough preoperative evaluations that were directed specifically at elucidating potential etiologies of CPP. Only women deemed likely after this evaluation to have gynecologic diagnoses that required laparoscopy for confirmation or treatment were taken to surgery. Patients with nongynecologic diagnoses and those with response to medical treatment of gynecologic diagnoses not requiring laparoscopy were not included. This seems a reasonable approach; not all women with CPP require laparoscopy.26 Finally, laparoscopy is not the termination of the evaluation of women with CPP, but only one portion of evaluation and treatment. 28 Many women are not cured by pelviscopy alone and require further evaluation and treatment. The gynecologist must be prepared to continue to evaluate and treat the woman with negative laparoscopic findings or with failed response to seemingly appropriate t r e a t m e n t of laparoscopically diagnosed disease. Conclusion Combining diagnostic and operative laparoscopy to allow simultaneous diagnosis and treatment of women with chronic pelvic pain of potential gynecologic origin is reasonable. Seventy-eight percent of women had a decrease of pain and 45% were pain free after this approach. Prior unsuccessful surgical treatment and prior treatment for chronic PID do not alter the outcome. Intervention with diagnostic and operative laparoscopy before 6 months of pelvic pain did not improve the response. The most frequent diagnoses were endometriosis and pelvic adhesive disease, accounting for about three-fourths of all diagnoses. A variety of other diagnoses accounted for
Laparoscopy and Chronic Pelvic Pain Howard
the remaining one-fourth. Response to laparoscopic t r e a t m e n t a p p e a r s to b e similar r e g a r d l e s s of the operative diagnosis.
15. Patty JR, Galle PC, McRae MA: Massive ovarian edema in a woman receiving clomiphene citrate. A case report. J Reprod Med 38:475-479, 1993
References
16. Howard FM, Sweeney TR: Omental herniatation after operative laparoscopy. J Reprod Med 1994;39
1. Howard FM: The role of laparoscopy in the evaluation of chronic pelvic pain: Promise and pitfalls. Obstet Gynecoi Surv 48:10-46, 1993
17. Nezhat N, Winer W, Nezhat F, et al: Laparoscopic treatment of endometriosis with laser and videocamera augm e n t a t i o n (videolaseroscopy). J Gynecol Surg 5:163-191, 1989
2. Roseff SJ, Murphy AA: Laparoscopy in the diagnosis and therapy of chronic pelvic pain. Clin Obstet Gynecol 33:137, 1990
18. Daniell JF, Kurtz BR, Gurley LD: Laser laparoscopic management of large endometriomas. Fertil Steril 55:692-695, 1991
3. Howard, FM: Breaking new ground or just digging a hole? An evaluation of gynecologic o p e r a t i v e laparoscopy. J Gynecol Surg 8:141-156, 1992
19. Sutton C, Hill D: Laser laparoscopy in the treatment of endometriosis: A 5-year study. Br J Obstet Gynaecol 97:181-185, 1990
4. Goldstein DP, D e C h o n o k y C, E m a n s S J, et al: Laparoscopy in the diagnosis and management of pelvic pain in adolescents. J Reprod Med 24:251-256, 1980 5. Sutton C, MacDonald R: Laser laparoscopic adhesiolysis. J Gynecol Surg 6:155-159, 1990
20. Steege JF, Stout AL: Resolution of chronic pelvic pain after laparoscopic lysis of adhesions. Am J Obstet Gynecol 165:278-283, 1991
6. Keye WR Jr, Hansen LW, Astin M, et al: Argon laser therapy of endometriosis: A review of 92 consecutive patients. Fertil Steri147:208-212, 1987
21. Sutton C, MacDonald R: Laser laparoscopic adhesiolysis. J Gynecol Surg 6:115-119, 1990
7. Hasson HM: Electrocoagulation of pelvic endometriotic lesions with laparoscopic control. Am J Obstet Gynecol 135:115-121, 1979
22. Vercellini P, Fedele L, Molteni P, et al: Laparoscopy in the diagnosis of gynecologic chronic pelvic pain. Int J Gynecol Obstet 32:261-265, 1990
8. Gurgan T, Develioglu O, Urman B, et al: Laparoscopic CO2 laser uterine nerve ablation for treatment of drug resistant p r i m a r y d y s m e n o r r h e a . Fertil Steril 58:422-424, 1992
23. Kresch AJ, Seifer DB, Sachs LB, et al: Laparoscopy in 100 women with chronic pelvic pain. Obstet Gynecol 64:672-674, 1984
9. Rapkin A J, Kames LD. The pain m a n a g e m e n t a p p r o a c h to chronic pelvic pain. J R e p r o d Med 32:323-327, 1987
24. Jacobson L, Westrom L: Objectivized diagnosis of acute pelvic inflammatory disease. Am J Obstet Gynecol 105:1088-1098, 1969
10. Martin DC, H u b e r t GD, Vander Zwagg R, et al: Laparoscopic appearances of peritoneal endometriosis. Fertil Steril 51:63-67, 1989
25. Steege JF: Chronic Pelvic Pain. Technical bulletin 129. Washingon, DC, American College of Obstetricians and Gynecologists, 1989
11. Hasson HM: Laparoscopic management of ovarian cysts. J Reprod Med 35:863-867, 1990
26. Peters AAW, van Dorst E, Jellis B, et al: A randomized clinical trial to compare two different approaches in women with chronic pelvic pain. Obstet Gynecol 77:740-744, 1991
12. Steege JF: Ovarian remnant syndrome. Obstet Gynecol 70:64-67, 1987 13. Christ JE, Lotze EC: The residual ovary syndrome. Obstet Gyneco146:551-556, 1975
27. B e e c h e r HK: The 159:1602-1606, 1955
14. Droegemueller W: Upper Genital Tract Infections. In Comprehensive Gynecology. Edited by AL Herbst, DR Mishell, MA Stenchever, et al. St. Louis, CV Mosby, 1991, p 692
powerful
placebo.
JAMA
28. Steege JF, Stout AL, Somkuti SG: Chronic pelvic pain in women: Toward an integrative model. Obstet Gynecol Surv 1993;48:95-110, 1993
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Laparoscopic Evaluation and Treatment of Women With Chronic Pelvic Pain Fred M. Howard, M.D.
Abstract Study Objective. To evaluate the effectiveness of operative laparoscopic treatment at the time of diagnostic laparoscopy in patients with chronic pelvic pain (CPP). Design. A retrospective study of women with CPP and at least 6 months of follow-up after laparoscopic evaluation and treatment. Setting. A faculty practice and community teaching hospital. Patients. A series of 65 consecutive women with greater than 1 month of pelvic pain who underwent laparoscopy. Thirty-two were referred by other physicians for evaluation of CPP. Interventions. Patients had operative laparoscopic treatment of all abnormal findings at the time of diagnostic laparoscopy. Nonspecific treatment such as presacral neurectomy or uterine nerve ablation was not performed. Measurements and Main Results. After laparoscopic evaluation and treatment, 78% of patients had decreased pain and 45% were pain free. Prior unsuccessful medical or surgical treatment did not affect the response rate. Endometriosis and adhesive disease were the roost common diagnoses, 38% and 34%, respectively. Conclusions. Laparoscopic surgical treatment of pathology noted at the time of diagnostic laparoscopy in women with CPP is appropriate, but less than one-half of patients may be expected to have complete pain relief. Procedures undertaken to evaluate women with chronic pelvic pain (CPP) vary widely, but diagnostic laparoscopy is usually performed. A survey of recently published series suggests that 40% of all laparoscopies are done for CPP, and that the figure may actually be increasing. 1 Although this may be due to the prevalence of CPP, it seems more likely attribut-
a b l e to t h e o p i n i o n o f m o s t g y n e c o l o g i s t s t h a t l a p a r o s c o p y is m a n d a t o r y f o r e v a l u a t i n g t h e s e patients. 2 With the rapid development of advanced operative laparoscopy (pelviscopy) over the past 2 decades, laparoscopy has assumed more than just a diagnostic role in CPP. These developments have allowed gyne-
From the Department of Obstetrics and Gynecology, Rochester General Hospital, and the University of Rochester School of Medicine and Dentistry, Rochester, New York. Address reprint requests to Fred M. Howard, M.D., Department of Obstetrics and Gynecology, Rochester General Hospital, 1425 Portland Avenue, Rochester, NY 14621. Presented at the 22rid annual meeting of the American Association of GynecologicLaparoscopists,San Francisco.
325
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cologists to perform operative laparoscopy in many patients, avoiding the need for l a p a r o t o m y . Pelviscopic treatment often is done at the same time as diagnostic laparoscopy,3 an approach that is common 4.s despite lack of prospective or controlled trials demonstrating its effectiveness. In addition, most published studies of combined diagnostic and operative laparoscopy report results for specific diagnoses (e.g., endometriosis) 6, 7 or specific procedures (e.g., uterosacral nerve ablation) 8 rather than the mixture of diagnoses and treatments the practicing gynecologist usually encounters. Thus, they do not generally address the predicament faced by the gynecologist during preoperative counseling, when the diagnosis is not known and the patient wishes information about her chances that combined diagnostic and operative laparoscopy will cure her pain. The present study was undertaken to address the effectiveness of combined diagnostic and operative laparoscopy in patients with CPP. Materials and Methods Office, operative, and hospital records of all women on whom I performed laparoscopy for CPP from July 1991 to July 1992 were reviewed. Prior to laparoscopy, the patients had thorough evaluations that included at least complete histories and physical examinations, cervical cultures for gonorrhea, cervical smears for Chlamydia, urine cultures, pregnancy testing, Papanicolaou smears, and complete blood cell counts. Sonography was not a preoperative prerequisite, but most patients had transvaginal or transabdominal ultrasound examinations. Women with pain attributed to nongynecologic diagnoses and those responsive to medical therapy did not undergo laparoscopy and are not included in this report. The definition of CPP during this interval was nonmenstrual pain of 1 or more months' duration that was localized to the anatomic pelvis, was severe enough to cause functional disability, and required medical or surgical treatment. The generally accepted duration for CPP is 6 months,9 but a shorter time was allowed in this study to permit evaluation of early diagnostic and operative interventions. All patients were asked to grade their pain subjectively as none, mild, moderate, or severe at all visits, both preoperatively and postoperatively. Numerical severity scores from 3, severe pain, to 0, no pain, were then assigned to allow statistical evaluation. Patients were consid-
326
ered pain free only if they denied pelvic pain (score 0). All women with pain relief after laparoscopy had at least 6 months of follow-up. Those with pain relief but less than 6 months of follow-up were recorded as lost. Follow-up with a referring physician was considered acceptable if records were available and if the visits included patient evaluations of pain intensity. Primary diagnoses were based on a combination of. clinical, o p e r a t i v e , and histologic findings. Endometriosis was diagnosed solely on visual findings only in cases with classic endometriotic lesions, such as black or powder burn lesions. In patients with subtle or atypical lesions, such as red, white, clear, or peritoneal pocket lesions, the diagnosis was made only by histologic c o n f i r m a t i o n . ~° If p r e s e n t , endometriosis was always considered the primary diagnosis. Staging was done at the time of surgery a c c o r d i n g to the revised classification of the American Fertility Society. Adhesions were considered a primary diagnosis only if they involved the pelvic reproductive viscera. Thus, bowel adhesions were not considered diagnostic unless they were adherent to the uterus, fallopian tubes, ovaries, or uterine ligaments. Ovarian cysts, including corpora lutea, were considered as diagnoses if they had been persistent for greater than one menstrual cycle and were consistent with the location of the patient's pelvic pain. u Ovarian remnant syndrome was diagnosed only with histologic confirmation of ovarian tissue after documented prior bilateral oophorectomy.~2 Residual ovary syndrome was diagnosed with adhesions and/or cystic change of retained ovaries after a hysterectomy. ~3 Chronic salpingitis was diagnosed with adhesions and hydrosalpinges of one or both fallopian tubes without evidence of acute infection. 14 Ovarian edema was diagnosed based on visualization of ovarian enlargement and histologic confirmation of marked ovarian edema. 15Leiomyoma, chronic appendicitis, and benign cystic teratoma were diagnosed by histologic confirmation and with locations consistent with the location of pelvic pain. I performed or supervised the laparoscopies of all patients in this study. The cases were assigned 2 hours of operative time to allow combined diagnostic and operative procedures. A multiple-puncture technique (two or more cannula sites) was used in all cases to allow complete pelvic visualization. Operative laparoscopies were performed with a three- or four-puncture technique using a variety of modalities depending on the surgical procedure. An attempt was always
Laparoscopy and Chronic Pelvic Pain Howard
made to reestablish normal pelvic anatomy and to treat all visible abnormalities thought to be potential causes of CPP. Carbon dioxide laser, monopolar and bipolar electrosurgery, and hydrodissection were used to treat endometriosis and adhesions and to perform excisional biopsies. Care was taken to ablate or excise fully all endometriotic lesions and adhesions. Endoscopic loop ligatures, sutures, and bipolar coagulation were used for oophorectomies, myomectomies, salpingectomies, and hysterectomies as surgically indicated. Ovarian cystectomies were performed with a stripping technique without repair of the defect. Peritoneal and ovarian lesions were liberally biopsied for histologic evaluation. Neither uterine nerve ablations nor presacral neurectomies were performed on any of these patients. Adhesion-prevention barriers and endoscopic stapler-cutters were not used. Statistics were calculated using the Epilnfo program version 5 (Centers for Disease Control, Atlanta, GA). Student's t test or Kruskal-Wallis analysis was used to compare means (Kruskal-Wallis if the variances were dissimilar by analysis of variance). Frequencies or distributions were compared by either Z~-or Fischer's exact analysis.
TABLE 1. Pain Characteristics and Associated Symptoms of Women With CPP Characteristic
Number or Mean _+SD
Percentage or Range
Duration of pain (mo) Location of pain Bilateral/midline Left only Right only Dysmenorrhea Dyspareunia Dyspareunia + dysmenorrhea Low back pain Gastrointestinal symptoms Headaches Urinary symptoms
22.7 + 38.1
1-244
23 26 16 35 28 22 11 9 8 3
35.4 40.0 24.6 53.8 43.1 33.8 16.9 13.8 12.3 4.6
Clinical Response After laparoscopic evaluation and treatment, 29 (45%) women were pain free. Mean follow-up in these patients was 10.7 _+3.8 months (range 6-18 mo). Figure 1 shows the postoperative responses for the major clinical diagnoses. The numbers for individual diagnoses are too small to draw any conclusions about comparative response rates. However, patients with the three most frequent diagnoses, endometrio-
Results
Sixty-five women (mean age 31.0 ___6.9 yrs, range 17-52 yrs) underwent laparoscopy for evaluation and treatment of CPP during the 12 months of this study. Their mean parity was 1.7 _+ 1.2 (range 0-5), and 15 (23%) patients were nulliparous (mean duration 11.7_+ 4.2 mo, mean no. of visits 3.2 _+ 1.8, range 0-9 visits). We followed 62 (95%) women for 6 months or longer (range 6-20 mo). Three patients were lost to follow-up before the sixth postoperative month. Thirty (46%) were Medicaid insured and 35 (54%) had private insurance. T h i r t y - t w o (49%) were referred by other physicians specifically for evaluation of CPP. Pain characteristics and associated symptoms are summarized in Table 1.
TABLE 2. Operative Procedures Performed at Time of Laparoscopy Operative Procedures
Number
Adhesiolysis 47 Ovarian cystectomy 25 Excision of endometriosis 21 Diagnostic biopsy 15 Ablation of endometriosis 13 Paratubal cystectomy 9 Bilateral tubal ligation 5 Dilatation & curettage 5 Ovarian cystotomy 4 Oophorectomy 4 Myomectomy 3 Appendectomy 2 Ovarian cystectomy, bilateral 2 Salpingo-oophorectomy 2 Laparoscopic hysterectomy 1 Salpingo-oophorectomy, bilateral 1 Totals 159 Mean number of procedures per patient = 2.4.
Operative Procedures One hundred fifty-nine operative procedures were p e r f o r m e d at the time of the d i a g n o s t i c laparoscopy in these patients (average 2.4 procedures/patient, range 0-4; Table 2). Histology specimens were submitted in 54 of the 65 cases.
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Percent 72.3 38.5 32.2 23.1 20.0 13.9 7.7 7.7 6.1 6.1 4.6 3.1 3.1 3.1 1.5 1.5 244.6
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311
N
[] Pain-fmei 0 Pain Lost
-F--.--t
26
N
Number 16 10
TOTAL
Endonwbiosis
Adhesions
No diagnosis
All ovarian
Oihers
FIGURE 1. Pain relief after laparoscopic diagnosis and treatment in 65 women with chronic pelvic pain.
sis, adhesions, and ovarian pathology, had similar responses, 44%, 50%, and 38%, respectively. Of the 33 women with continued pain, 22 had persistent pain at their initial postoperative visit. Eleven were initially pain free, but subsequently developed recurrent pain, albeit less severe. In two pain recurred at 1 month, in four at 2 months, and in one each at 3, 5, 8, 12, and 14 months. The frequency of adhesiolysis was not different in those with recurrent pain than in the rest of the population (p = 0.64) or those who remained pain free (p = 0.76). Mean pain severity scores were 2.8 + 0.4 preoperatively and 1.1 + 1.2 postoperatively (p <0.001). Preoperatively, 55 women had severe pain and 10 had moderate pain; 6 of the latter were pain free postoperatively, compared with 23 of the former (p -- 0.32). Only 11 patients, all with severe pain preoperatively, showed no decrease whatsoever in pain level after surgery. Overall, 51 (82%) of the 62 patients with follow-up had decreased pain. The mean duration of pain preoperatively was 15.5 _ 16.1 months in women who were pain free postoperatively, compared with 28.5 + 48.7 months in those with continued pain or lost to follow-up (p -0.063). Five patients had greater than 5 years of CPP, and none of them was pain free postoperatively. Twenty-one women had 1 to 6 months of CPP
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preoperatively, and 44 had 6 or more months. The response to operative treatment in patients in the first group was lower (8/21, 38%) than that in the second (21/44, 48%), but this difference was not statistically significant (p = 0.46). Twenty-seven women had undergone previous unsuccessful surgical treatment for CPP. Of these, 13 (48%) were pain free, 13 (48%) had continued pain, and 1 (4%) was lost to follow-up. Thirty-eight had not had any prior surgical treatment specifically for CPP; 16 (42%) were pain free, 20 (53%) had continued pain, and 2 (5%) were lost. These results were not clinically or statistically different (p = 0.63).
Diagnoses An operative diagnosis was made in 60 (92%) patients. The most frequent primary diagnoses were endometriosis and adhesions, accounting for 38% and 34%, respectively (Table 3). No other individual diagnosis accounted for more than 5% of the total, although the ovarian diagnoses (corpus luteum, residual ovary, ovarian remnant, ovarian edema, cystic teratoma) accounted for 12% of the total (8/65). One additional patient also had ovarian remnant syndrome, but had histologically confirmed endometriosis as well, which was c o n s i d e r e d the p r i m a r y diagnosis.
Laparoscopy and Chronic Pelvic Pain Howard
TABLE 3. Primary LaparoscopicDiagnoses Diagnosis Endometriosis Adhesions No diagnosis Left corpus luteum Chronic salpingitis Residual ovary syndrome Ovarian remnant syndrome Chronic appendicitis Foreign body reaction Ovarian edema Leiomyoma Right cystic teratoma Totals
Number 25 22 5 3 2 2 1 1 1 1 1 1 65
Complications Complications occurred in six patients (9%). Two of these were intraoperative: a rectosigmoid bowel injury during posterior colpotomy, and an epigastric artery laceration. Both were managed laparoscopically without further untoward events. The woman with laparoscopic bowel injury and repair was admitted to the hospital for observation and antibiotic prophylaxis for 3 days. The woman with epigastric artery laceration was discharged on the day of surgery. The four postoperative complications were two pelvic infections, one umbilical wound infection, and one umbilical herniation of omentum. Women with infections were managed on an ambulatory basis. The one with omental herniation underwent operative excision, reclosure of the umbilical incision, and hospital observation for 48 hours? 6 No patients required a laparotomy.
Percent 38.5 33.8 7.7 4.6 3.0 3.0 1.5 1.5 1.5 1.5 1.5 1.5 100.0
Prior Treatment Overall, 55 (85%) women had had some form of unsuccessful treatment for CPP. Forty had undergone abdominopelvic surgery, six of whom had two procedures. Thirty of these procedures, involving 27 patients, were performed specifically for CPP: 9 laparotomies; 15 laparoscopies; and 6 hysterectomies, with removal of both adnexae in 3. Thirteen patients had previously been diagnosed as having endometriosis. The original diagnoses were based only on visual findings in 11 and on histologic findings in 2. Endometriosis was again diagnosed in only 5 (38%) of these 13 women, mild disease in 4 and moderate in 1. Endometriosis was not found in the other eight patients, and instead the laparoscopic diagnoses were adhesions (5), residual ovary syndrome (1), ovarian remnant syndrome (1), and no diagnosis (1). Twenty-five of the 65 women had been diagnosed and treated for pelvic inflammatory disease (PID). However, laparoscopic evidence of chronic salpingitis was found in only five, two of whom had not been previously diagnosed or treated for PID. Chronic salpingitis was the primary operative diagnosis in only two patients, only one of whom had been treated for PID. Seventeen of the 30 Medicaid-insured patients had a history of treatment for PID, compared with only 8 of the 35 privately insured patients (p = 0.005). Of the five women with intraoperative findings consistent with chronic salpingitis, two were insured by Medicaid and three privately.
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Discussion
This study suggests that during preoperative counseling a gynecologist may reasonably tell the patient with CPP that after combined diagnostic and operative laparoscopy she has about a 45% chance that she will be pain free for 6 months or more; a 30% to 35% chance that she will have decreased but continued pain; and a 20% to 25% chance that she will derive no benefit from the procedure. These outcomes appear to be relatively consistent regardless of the diagnosis. In addition, these results are similar to those reported specifically for laparoscopic treatment of endometriosis~7-19and adhesions.2°,21 Endometriosis and adhesions are the two most frequent diagnoses made at laparoscopy for CPP, each accounting for about one-third. Most other studies reported no laparoscopic diagnosis in one-third or more of patients, l, z~,23 However, this series showed a much higher rate of positive findings, with a specific diagnosis made in 9 of 10 women. This higher rate may be due to the fact that patients with pain attributed to nongynecologic diagnoses and those responsive to medical therapy did not undergo laparoscopy and were not included in this study. Also, 15% of the women had ovarian abnormalities thought responsible for pelvic pain, but some of these diagnoses, particularly corpus luteum, benign cystic teratoma, and ovarian edema, are unproved and debatable causes of CPP. Several factors that were expected to affect the
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response to treatment, in fact, did not. About 50% of patients who had had surgery for CPP, including three of six with hysterectomies, were pain free after pelviscopy, which was not significantly different from the response rate of patients who had not had such treatment. Obviously clinical judgment is necessary, but one should not per se assume that if previous surgery was unsuccessful, combined diagnostic and operative laparoscopy has no role. It was previously hypothesized that earlier intervention might either prevent the development of CPP or improve response to treatment. 1 Therefore, the definition of CPP was reevaluated during this study by including patients with less than 6 months of pain. However, no greater improvement in response to treatment was found in these patients than in women with more than 6 months of pain. The results of this study call into question the use of the diagnosis of PID, especially chronic PID. Although 25 women in this series had been treated for PID as an approach to treating CPP, only 3 of them had any evidence of salpingitis at laparoscopy. Furthermore, the preoperative diagnosis of PID was much more common in Medicaid than in privately insured patients. Although this is not proof that the diagnosis was incorrect, this fact lends itself to that interpretation. Certainly, it seems appropriate to suggest that patients with CPP should not be labeled with a diagnosis of PID or chronic PID without objective laparoscopic evidence.24 The presence of chronic pain syndrome was suggested to be a preoperative predictor of poorer response to laparoscopic adhesiolysis.20 Response to treatment was only 40% in women with the syndrome, compared with 75% in those without it. Patients with four or more of the following characteristics are considered to have chronic pain syndrome: duration of pain for 6 or more months; incomplete relief by most previous treatments; significantly impaired function at home or work; signs of depression; pain out of proportion to pathology; and altered family roles. 25 Unfortunately, the design of the present study did not allow evaluation of this syndrome, but two of the characteristics, 6 or more months' duration and incomplete relief with previous therapy, were not supported as being individually predictive of response in this series. Possibly the four psychologic and behavioral characteristics are more significant than are duration of pain and history of prior treatment in defining chronic pain syndrome and in distin-
330
guishing these patients from others with CPP. Although the results of this study are optimistic, two particular points should be made. First, this was a r e t r o s p e c t i v e , u n c o n t r o l l e d r e p o r t of a series. Therefore, it cannot be concluded that combined diagnostic and operative laparoscopy for CPP can be definitively considered efficacious or superior to other modes of treatment. 9, 26 It is worth noting that the pain-free response rate was only 10% higher than the placebo effectiveness of 35.2 _+2.2% in Beecher's classic studies of placebo/7 Also, of five patients in this study with no diagnosis, two were pain free for the duration of follow-up (17 and 19 mo). Second, this was a selected population. All patients underwent thorough preoperative evaluations that were directed specifically at elucidating potential etiologies of CPP. Only women deemed likely after this evaluation to have gynecologic diagnoses that required laparoscopy for confirmation or treatment were taken to surgery. Patients with nongynecologic diagnoses and those with response to medical treatment of gynecologic diagnoses not requiring laparoscopy were not included. This seems a reasonable approach; not all women with CPP require laparoscopy.26 Finally, laparoscopy is not the termination of the evaluation of women with CPP, but only one portion of evaluation and treatment. 28 Many women are not cured by pelviscopy alone and require further evaluation and treatment. The gynecologist must be prepared to continue to evaluate and treat the woman with negative laparoscopic findings or with failed response to seemingly appropriate t r e a t m e n t of laparoscopically diagnosed disease. Conclusion Combining diagnostic and operative laparoscopy to allow simultaneous diagnosis and treatment of women with chronic pelvic pain of potential gynecologic origin is reasonable. Seventy-eight percent of women had a decrease of pain and 45% were pain free after this approach. Prior unsuccessful surgical treatment and prior treatment for chronic PID do not alter the outcome. Intervention with diagnostic and operative laparoscopy before 6 months of pelvic pain did not improve the response. The most frequent diagnoses were endometriosis and pelvic adhesive disease, accounting for about three-fourths of all diagnoses. A variety of other diagnoses accounted for
Laparoscopy and Chronic Pelvic Pain Howard
the remaining one-fourth. Response to laparoscopic t r e a t m e n t a p p e a r s to b e similar r e g a r d l e s s of the operative diagnosis.
15. Patty JR, Galle PC, McRae MA: Massive ovarian edema in a woman receiving clomiphene citrate. A case report. J Reprod Med 38:475-479, 1993
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