Medical treatment or surgery for colorectal endometriosis? Results of a shared decision-making approach.

STUDY QUESTION: What is the degree of patient satisfaction in women with symptomatic colorectal endometriosis who choose medical or surgical treatment after a shared decision-making (SDM) process? SUMMARY ANSWER: The degree of satisfaction with treatment was high both in women who chose medical treatment with a low-dose oral contraceptive (OCP) or a progestin, and in those who chose to undergo surgical resection of bowel endometriosis. WHAT IS KNOWN ALREADY: Hormonal therapies and surgery for colorectal endometriosis have been investigated in non-comparative studies with inconsistent results. STUDY DESIGN, SIZE, DURATION: Parallel cohort study conducted on 87 women referring to our centre with an indication to surgery for colorectal endometriosis. A standardised SDM process was adopted, allowing women to choose their preferred treatment. Median follow-up was 40 [18-60] months in the medical therapy group and 45 [30-67] in the surgery group. PARTICIPANTS/MATERIALS, SETTING, METHODS: Patients with endometriosis infiltrating the proximal rectum, the rectosigmoid junction, and the sigmoid, not causing severe sub-occlusive symptoms were enroled. A total of 50 patients chose treatment with an OCP (n = 12) or a progestin (n = 38), whereas 37 women confirmed their previous indication to surgery. Patient satisfaction was graded according to a 5-category scale. Variations in bowel and pain symptoms were measured by means of a 0-10 numeric rating scale. Constipation was assessed with the Knowles-Eccersley-Scott Symptom Questionnaire (KESS), health-related quality of life with the Short Form-12 questionnaire (SF-12), psychological status with the Hospital Anxiety and Depression scale (HADS) and sexual functioning with the Female Sexual Function Index (FSFI). MAIN RESULTS AND THE ROLE OF CHANCE: Six women in the medical therapy group requested surgery because of drug inefficacy (n = 3) or intolerance (n = 3). Seven major complications were observed in the surgery group (19%). At 12-month follow-up, 39 (78%) women in the medical therapy group were satisfied with their treatment, compared with 28 (76%) in the surgery group (adjusted odds ratio (OR), 1.37; 95% confidence interval (CI), 0.45-4.15; intention-to-treat analysis). Corresponding figures at final follow-up assessment were 72% in the former group and 65% in the latter one (adjusted OR, 1.74; 95% CI, 0.62-4.85). The 60-month cumulative proportion of dissatisfaction-free participants was 71% in the medical therapy group compared with 61% in the surgery group (P = 0.61); the Hazard incidence rate ratio was 1.21 (95% CI, 0.57-2.62). Intestinal complaints were ameliorated by both treatments. Significant between-group differences in favour of medical treatment were observed at 12-month follow-up in diarrhoea, dysmenorrhoea, non-menstrual pelvic pain and SF-12 physical component scores. The total HADS score improved significantly in both groups, whereas the total FSFI score improved only in women who chose medical therapy. LIMITATIONS REASONS FOR CAUTION: As treatments were not randomly assigned, selection bias and confounding are likely. The small sample size exposes to the risk of type II errors. WIDER IMPLICATIONS OF THE FINDINGS: When adequately informed and empowered through a SDM process, most patients with non-occlusive colorectal endometriosis who had already received a surgical indication, preferred medical therapy. The possibility of choosing the preferred treatment may allow maximisation of the potential effect of the interventions. STUDY FUNDING/COMPETING INTEREST(S): This study was financed by Italian fiscal contribution '5 × 1000'-Ministero dell'Istruzione, dell'Università e della Ricerca-devolved to Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy. P.V., M.P.F., R.R., D.D., A.R., P.M., O.D.G. and M.C. declare that they have no conflicts of interest. E.S. received grants from Ferring and Serono.

Reproductive performance, pain recurrence and disease relapse after conservative surgical treatment for endometriosis: the predictive value of the current classification system.

BACKGROUND: To assess the predictive value of the current classification of endometriosis in terms of response to surgical treatment, we studied to what extent disease stage, lesion type and lesion site were associated with post-operative pregnancy rate, symptom recurrence and disease relapse. METHODS: A total of 729 women with endometriosis undergoing first-line conservative laparoscopic surgery were included. Data on age at surgery, disease stage according to the revised American Fertility Society (AFS) classification, anatomical characteristics of endometriotic lesions, fertility status and types and severity of pain symptoms were collected. RESULTS: Minimal endometriosis was present in 222 patients, mild in 106, moderate in 197 and severe in 204. The cumulative probability of pregnancy at 3 years from surgery in 537 infertile women was 47% (51% at stage I, 45% at stage II, 46% at stage III and 44% at stage IV; log-rank test, chi(2)3=1.50, P=0.68). The cumulative probability of moderate or severe dysmenorrhoea recurrence in 425 symptomatic subjects was 24% (32% at stage I, 24% at stage II, 21% at stage III and 19% at stage IV; log-rank test, chi2(3)=6.39, P=0.094). The cumulative probability of disease relapse was 12% (3% at stage I, 11% at stage II, 11% at stage III and 23% at stage IV; log-rank test, chi(2)3=24.95, P=0.0001). Using Cox's multivariate proportional hazards regression analysis, no association was observed between endometriosis stage or lesion type and lesion site and any of the considered study outcomes. CONCLUSIONS: The current classification of endometriosis has an inadequate predictive value with regard to the major clinical outcomes.

Reproductive performance in infertile women with rectovaginal endometriosis: is surgery worthwhile?

OBJECTIVE: This study was undertaken to ascertain whether the incidence of pregnancy is increased and time-to-conception is reduced in infertile women with rectovaginal endometriosis undergoing conservative surgery compared with those on expectant management. STUDY DESIGN: A total of 105 infertile women under the age of 40 years with rectovaginal endometriosis and no other associated major infertility factor underwent first-line conservative surgery at laparotomy or expectant management according to a shared decision-making approach. RESULTS: Among the 44 women who had resection of rectovaginal endometriosis, 15 became pregnant, compared with 22 of the 61 women who choose expectant management (24-month cumulative probabilities, 44.9% and 46.8%, respectively; log-rank test, chi2(1) = 0.75; P = .38). One major and 9 minor postoperative complications occurred. Significant differences in pain-free survival time in favor of the surgery group were observed for dysmenorrhea, dyspareunia, and dyschezia. CONCLUSION: Conservative surgery for rectovaginal endometriosis in infertile women does not modify the reproductive prognosis although it does increase pain-free survival time.

Treatment of symptomatic rectovaginal endometriosis with an estrogen-progestogen combination versus low-dose norethindrone acetate.

OBJECTIVE: To evaluate the efficacy, safety, and tolerability of an estrogen-progestogen combination versus low-dose norethindrone acetate in the treatment of persistent pain after surgery for symptomatic rectovaginal endometriosis. DESIGN: Randomized controlled trial. SETTING: Academic center. PATIENT(S): Ninety women with recurrent moderate or severe pelvic pain after unsuccessful conservative surgery for symptomatic rectovaginal endometriosis. INTERVENTION(S): Twelve-month, continuous treatment with oral ethinyl E2, 0.01 mg, plus cyproterone acetate, 3 mg/day, or norethindrone acetate, 2.5 mg/day. MAIN OUTCOME MEASURE(S): Degree of satisfaction with therapy. RESULT(S): Seven women in the ethinyl E2 plus cyproterone acetate arm and five in the norethindrone acetate arm withdrew because of side effects (n=5), treatment inefficacy (n=6), or loss to follow-up (n=1). At 12 months, dysmenorrhea, deep dyspareunia, nonmenstrual pelvic pain, and dyschezia scores were substantially reduced without major between-group differences. Both regimens induced minor unfavorable variations in the serum lipid profile. According to an intention-to-treat analysis, 28 (62%) out of 45 patients in the ethinyl E2 plus cyproterone acetate group and 33 (73%) out of 45 in the norethindrone acetate group were satisfied with the treatment received. CONCLUSION(S): Low-dose norethindrone acetate could be considered an effective, tolerable, and inexpensive first-choice medical alternative to repeat surgery for treating symptomatic rectovaginal endometriotic lesions in patients who do not seek conception.

Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen.

OBJECTIVE: To ascertain whether long-term reduction of pain is obtained by continuous administration of an oral contraceptive (OC) in women with endometriosis-associated recurrent dysmenorrhea that does not respond to cyclic OC use. DESIGN: Prospective, therapeutic, self-controlled clinical trial. SETTING: A tertiary care and referral center for patients with endometriosis. PATIENT(S): Fifty women who underwent surgery for endometriosis in the previous year and experienced recurrent dysmenorrhea despite cyclic OC use. INTERVENTION(S): Continuous use of an OC containing ethinyl estradiol (0.02 mg) and desogestrel (0.15 mg) for 2 years. MAIN OUTCOME MEASURE(S): Dysmenorrhea variation during cyclic and continuous OC use, evaluated with a 100-mm visual analog scale and a 0- to 3-point verbal rating scale, and degree of satisfaction with continuous OC treatment. RESULT(S): In the study period, amenorrhea, spotting, and breakthrough bleeding were reported by 19 (38%), 18 (36%), and 13 (26%) women. The mean +/- SD number of >7-day bleeding episodes with consequent 7-day OC suspension was 5.5 +/- 2.1. The mean +/- SD dysmenorrhea visual analog scale and verbal rating scale scores were 75 +/- 13 and 2.4 +/- 0.5 at baseline and 31 +/- 17 and 0.7 +/- 0.6 at 2-year follow-up, respectively. Moderate or severe side effects were reported by 7/50 (14%) women. At final evaluation, 13 (26%) women were very satisfied, 27 (54%) were satisfied, 1 (2%) was uncertain, 8 (16%) were dissatisfied, and 1 (2%) was very dissatisfied. CONCLUSION(S): Long-term continuous OC use can be proposed to women with symptomatic endometriosis and menstruation-related pain symptoms.

Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study.

OBJECTIVE: To determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a levonorgestrel-releasing intrauterine device (Lng-IUD) is inserted after operative laparoscopy compared with those treated with surgery only. DESIGN: Open-label, parallel-group, randomized, controlled trial. SETTING: A tertiary care and referral center for patients with endometriosis. PATIENTS(S): Parous women with moderate or severe dysmenorrhea undergoing first-line operative laparoscopy for symptomatic endometriosis. INTERVENTION(S): Randomization to immediate Lng-IUD insertion or expectant management after laparoscopic treatment of endometriotic lesions. Proportions of women with recurrence of moderate or severe dysmenorrhea in the two study groups 1 year after surgery and overall degree of satisfaction with treatment. Moderate or severe dysmenorrhea recurred in 2 of 20 (10%) subjects in the postoperative Lng-IUD group and 9/20 (45%) in the surgery-only group. Thus, a medicated device inserted postoperatively will prevent the recurrence of moderate or severe dysmenorrhea in one out of three patients 1 year after surgery. A total of 15/20 (75%) women in the Lng-IUD group and 10/20 (50%) in the expectant management group were satisfied or very satisfied with the treatment received. CONCLUSION(S): Insertion of an Lng-IUD after laparoscopic surgery for symptomatic endometriosis significantly reduced the medium-term risk of recurrence of moderate or severe dysmenorrhea.

Endometriosis: preoperative and postoperative medical treatment.

The quality of the evidence that supports the use of medical treatment before conservative surgery for endometriosis is manifestly poor, and no recommendations can be made based on the results of the published studies. There are practical advantages inherent to this schedule, but whether this translates into better conception rates and reduced pain recurrence rates is unproven. The effect of drug therapy after surgery can be assessed better as data from seven true randomized, controlled trials are available. The results of the current review do not support the notion that suppressing ovarian activity postoperatively increases the long-term pregnancy rate. As far as pelvic pain is concerned, more data are needed to verify the reduced symptoms recurrence rate found in four trials in women who were allocated to postoperative medical therapy, particularly in view of the different results obtained in some of the considered studies. The observed differences among various drugs used before or after surgery are limited in clinical terms and, in the absence of formal randomized comparisons, are difficult to interpret. Because of their tolerable side effects and limited cost, progestins with or without estrogens should be considered strongly as first-line postoperative medical treatment if and when suppression of ovulation after conservative surgery is deemed opportune.

Coagulation or excision of ovarian endometriomas?

A systematic review was undertaken to determine whether coagulation or laser vaporization of endometriomas is associated with an increase in the risk of cyst recurrence compared with excision of the pseudocapsule. In the four comparative trials identified, endometrioma recurrence was reported in 39 of 212 (18.4%) women treated with coagulation or laser vaporization compared with 19 of 295 (6.4%) in those who underwent cystectomy. The odds ratios of endometrioma recurrence ranged from 1.41 to 9.38 with 95% CIs including unity in two studies. The common odds ratio was 3.09 (95% CI 1.78-5.36). Coagulation or laser vaporization of endometriomas without excision of the pseudocapsule seems to be associated with a significant increase in risk of cyst recurrence.

The pathogenesis of bladder detrusor endometriosis.

OBJECTIVE: The purpose of this study was to ascertain whether bladder detrusor endometriosis originates intraperitoneally in the vesicouterine pouch or subperitoneally in the vesicovaginal septum and whether an association exists with uterine adenomyosis. STUDY DESIGN: Data were collected on clinical, diagnostic, and surgical characteristics of 40 women who were evaluated for primary, histologically confirmed, full-thickness detrusor endometriosis. RESULTS: In 19 of the 20 women who underwent surgery, the anterouterine pouch was partially or totally obliterated with the nodule that was located in the posterior wall or dome of the bladder, well above the uterine isthmus, and adherent to the anterior uterine wall or fundus. With one exception, pelvic ultrasonography, cystoscopy, intravenous pyelography, magnetic resonance imaging, and computed tomography identified the lesion cranially with respect to the vesicovaginal septum and excluded uterine adenomyosis. CONCLUSION: Vesical endometriosis seems to originate from the implantation of regurgitated endometrial cells in the anterior cul-de-sac and not to be associated with uterine adenomyosis. The metaplasia of subperitoneal mullerian remnants and the uterus-vesical adenomyosis extension theories are not compatible with most imaging, surgical, and pathologic findings.

Cyproterone acetate versus a continuous monophasic oral contraceptive in the treatment of recurrent pelvic pain after conservative surgery for symptomatic endometriosis.

OBJECTIVE: To evaluate the efficacy and safety of cyproterone acetate versus an oral contraceptive in the treatment of endometriosis-associated recurrent pelvic pain. DESIGN: Randomized controlled trial. SETTING: Academic center. PATIENT(S): Ninety women with recurrent moderate or severe pelvic pain after conservative surgery for symptomatic endometriosis. INTERVENTION(S): Six months of continuous treatment with oral cyproterone acetate, 12.5 mg/d, or an oral contraceptive containing ethinyl estradiol, 0.02 mg, and desogestrel, 0.15 mg. MAIN OUTCOME MEASURE(S): Degree of satisfaction with therapy. RESULT(S): Six patients in the cyproterone acetate arm and nine in the oral contraceptive arm withdrew because of side effects (n = 9), treatment inefficacy (n = 4), or loss to follow-up (n = 2). At 6 months, dysmenorrhea, deep dyspareunia, and nonmenstrual pelvic pain scores were substantially reduced, and significant improvements were observed in health-related quality-of-life, psychiatric profile, and sexual satisfaction; no major between-group differences were seen. Subjective and metabolic side effects were limited. According to an intention-to-treat analysis, 33 of 45 (73%) of patients in the cyproterone acetate group and 30 of 45 (67%) in the oral contraceptive group were satisfied with the treatment received. CONCLUSIONS: Both cyproterone acetate and a continuous monophasic oral contraceptive were effective, safe, and inexpensive therapy for recurrent pain after conservative surgery for endometriosis.