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Research Evaluation Unit, Oxford PharmaGenesis, Oxford, United KingdomDepartment of Mechanical Engineering and Mathematical Sciences, Oxford Brookes University, Oxford, United Kingdom
Among women treated surgically for endometriosis-associated pain, comprehensive data are lacking on the proportions of patients who experience little or no symptom relief, develop recurrent symptoms, or require further surgical treatment for endometriosis. The aim of this study was to assess the efficacy of surgical procedures used to treat endometriosis-associated pain.
Methods
Medline and Embase were searched on October 13, 2016. Articles referring to women undergoing surgery for the treatment of endometriosis-associated pain were screened by two independent investigators. For each included treatment arm, data were extracted for the proportion of patients reporting partial or no improvement after surgery for endometriosis-associated pain, pain recurrence, or requirement for further surgery.
Results
A total of 38 studies were included. Most studies did not report relevant outcomes to evaluate pain (71.1%) and recurrent surgery (68.4%). Of the women who underwent lesion excision, 11.8% reported no improvement in pain, and 22.6% underwent further surgery. Postoperative pain, recurrent pain, and adverse events were reported by 34.3%, 28.7%, and 14.8%, respectively, of patients who underwent excision or ablation of endometriosis combined with pelvic denervation and in 25.0%, 15.8%, and 8.1% of women who underwent lesion excision alone. Of the patients who were treated surgically for deep endometriosis affecting the bowel and/or bladder, 7.0% experienced recurrent symptoms, and 4.1% underwent further surgery.
Conclusion
This review supports the findings of previous studies and highlights the need for standardized reporting and more detailed follow-up after surgery for endometriosis-associated pain.
Résumé
Objectif
Pour les femmes ayant reçu un traitement chirurgical des douleurs liées à l'endométriose, on observe un manque de données sur la proportion de patientes qui éprouvent un soulagement partiel ou inexistant de leurs symptômes, qui connaissent une récidive des symptômes ou qui nécessitent des traitements chirurgicaux supplémentaires. Cette étude visait à évaluer l'efficacité des interventions chirurgicales utilisées pour traiter les douleurs liées à l'endométriose.
Méthodologie
Des recherches ont été menées dans Medline et Embase le 13 octobre 2016. Deux chercheurs indépendants ont évalué des articles faisant référence aux femmes qui subissent une intervention chirurgicale pour traiter les douleurs liées à l'endométriose. Pour chaque volet de traitement retenu, les données ont été extraites pour la portion de patientes qui rapportaient une amélioration partielle ou inexistante après une intervention chirurgicale pour traiter les douleurs liées à l'endométriose, présentaient une récidive des douleurs ou nécessitaient une intervention chirurgicale supplémentaire.
Résultats
Un total de 38 études ont été retenues. La plupart des études ne rapportaient pas de données pertinentes pour évaluer les douleurs (71,1 %) ni les interventions chirurgicales supplémentaires (68,4 %). Parmi les femmes qui ont subi une excision des lésions, 11,8 % ont rapporté ne ressentir aucune amélioration des douleurs et 22,6 % ont dû subir une intervention chirurgicale supplémentaire. On a rapporté des douleurs postopératoires, des douleurs récidivantes et des événements défavorables respectivement chez 34,3 %, 28,7 % et 14,8 % des patientes qui ont subi une excision ou une ablation de l'endométriose combinée à une dénervation pelvienne et chez 25,0 %, 15,8 % et 8,1 % des patientes qui ont subi une excision des lésions seulement. Des patientes qui ont subi un traitement chirurgical d'une atteinte endométriosique profonde du côlon et/ou de la vessie, 7,0 % ont connu une récidive des symptômes et 4,1 % ont subi une intervention chirurgicale supplémentaire.
Conclusion
Cette revue corrobore les conclusions d'études précédentes et fait ressortir le besoin d'uniformisation des déclarations et d'un suivi postopératoire détaillé après un traitement chirurgical des douleurs liées à l'endométriose.
For many women, endometriosis-associated pain (chronic pelvic pain, dysmenorrhoea, dyspareunia, dysuria, dyschezia) can have a significant impact on health-related quality of life.
The recommended surgical approach to manage endometriosis-associated pain depends on the type of lesion. Surgical excision or ablation is recommended for superficial lesions and full excision for deep endometriosis (previously termed “deep infiltrating endometriosis”) and endometriomas.
In some cases, radical surgery may be required to alleviate endometriosis-associated pain, such as pre-sacral neurectomy or hysterectomy with removal of the ovaries.
Medical treatments such as analgesics and hormonal agents may also be given as a preoperative or postoperative adjunct to surgery or as an alternative treatment strategy.
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Reproductive performance, pain recurrence and disease relapse after conservative surgical treatment for endometriosis: the predictive value of the current classification system.
However, comprehensive data are lacking for the proportion of patients who experience little or no pain relief, develop recurrent pain, or require further surgical treatment for endometriosis. Comparisons of these parameters are hampered by a lack of standardized approaches to postsurgical therapy and by sparse use of validated, standardized assessment tools in endometriosis trials.
The aim of this systematic review was to assess the response, recurrence, and reoperation rates for the full range of surgical procedures used to treat endometriosis-associated pain to determine their effectiveness and evaluate the need for new therapies.
METHODS
Search Strategy
Medline and Embase were searched using Ovid on October 13, 2016, to identify all studies reporting response to surgery for the treatment of endometriosis-associated pain (Figure); the search strings are provided in online Table 1. After removal of duplicates, all identified references were screened and categorized by two independent investigators. Prospective or retrospective studies evaluating the surgical treatment of endometriosis and reporting any of the following outcomes of interest were included: treatment response according to type of surgery or location of lesions, recurrence rate of endometriosis-associated pain or lesions, and number of women requiring further surgical treatment.
FigurePRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram of systematic searches and selection process.
Exclusion criteria were as follows: studies with fewer than 50 patients, follow-up duration of less than 6 months, studies of patients who received hormonal treatment after surgery, and articles that did not investigate endometriosis-associated pain as an outcome (Figure). The search was limited to English-language articles with an abstract available. No limit was set for the year of publication. The protocol has been registered with PROSPERO (ID: CRD42015017831). Articles were initially screened by title only; those meeting the exclusion criteria were removed. The remaining references were screened on the basis of abstracts and/or full text.
Data Analysis
For articles that were included in the study, data were extracted to calculate the proportions of patients reporting partial or no improvement in endometriosis-associated pain after surgery. Data for endometriosis-associated pain recurrence, reoperation rates, and adverse events (AEs) following surgery were also obtained.
For data analysis, papers were categorized into seven groups, according to type of intervention: diagnostic surgery, lesion excision (including endometrioma excision), lesion ablation, endometrioma drainage without cyst excision (herein referred to as the endometrioma drainage group), pelvic denervation, hysterectomy with or without ovarian preservation, and excision of deep endometriosis. Online Table 2 lists all the surgical techniques by group. Patients in the diagnostic surgery group underwent laparoscopy for diagnostic purposes but did not receive any surgical treatment.
In this review article, the findings are presented as medians (ranges are shown only in the tables and figures) or as single values.
RESULTS
Studies Meeting the Eligibility Criteria
Of 2185 articles identified, 38 were included in this study
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
When sex is not on fire: a prospective multicentre study evaluating the short-term effects of radical resection of endometriosis on quality of sex life and dyspareunia.
Change in pain and quality of life among women enrolled in a trial examining the use of narrow band imaging during laparoscopic surgery for suspected endometriosis.
(Figure). The main reasons for exclusion were use of medical therapy (n = 353), insufficient cohort size (n = 253), gynaecological cancer studies (n = 252), and “other” (n = 691).
Characteristics of Studies
Of the 38 studies, 65.8% were prospective, including 11 randomized controlled trials (RCTs) and one extension of an RCT, whereas 11 (28.9%) were retrospective cohort analyses, and one (2.6%) was a longitudinal study (Table 1). When categorized by intervention type, the two groups with the greatest number of surgical techniques were the lesion excision (14 techniques) and deep endometriosis (11 techniques) groups (online Table 2). Median duration of follow-up varied widely across the seven groups, ranging from 9 months for lesion ablation to 92 months for hysterectomy (Table 1).
Table 1Characteristics of studies included in the review
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
Change in pain and quality of life among women enrolled in a trial examining the use of narrow band imaging during laparoscopic surgery for suspected endometriosis.
When sex is not on fire: a prospective multicentre study evaluating the short-term effects of radical resection of endometriosis on quality of sex life and dyspareunia.
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
(online Table 2). Pelvic denervation was performed in combination with lesion excision or ablation in four studies. Directed lesion excision was the most common treatment class, reported in 25 studies and across 31 treatment arms. The effectiveness of hysterectomy was investigated in only one study.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
When sex is not on fire: a prospective multicentre study evaluating the short-term effects of radical resection of endometriosis on quality of sex life and dyspareunia.
Change in pain and quality of life among women enrolled in a trial examining the use of narrow band imaging during laparoscopic surgery for suspected endometriosis.
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
Quantitative assessments of endometriosis-associated pain before and/or after treatment were performed in 20 of the 23 studies that investigated this outcome: 18 (90.0%) used a 10-cm visual analogue scale (VAS),
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
When sex is not on fire: a prospective multicentre study evaluating the short-term effects of radical resection of endometriosis on quality of sex life and dyspareunia.
Change in pain and quality of life among women enrolled in a trial examining the use of narrow band imaging during laparoscopic surgery for suspected endometriosis.
Only 14 studies reported both baseline and postoperative VAS scores for endometriosis-associated pain.
Proportion of Patients With No Reduction in Endometriosis-Associated Pain
Only 11 studies (28.9%) reported the number of women with no reduction in endometriosis-associated pain immediately after surgery. Most women (77.4%) who underwent diagnostic surgery (one treatment arm; n = 31) reported no reduction in pain (Table 2, online Table 3, online Figure 1A).
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
The inclusion of surgical techniques was based on the treatment arms in the studies. Not all of the studies differentiated between laparoscopy and laparotomy.
a The inclusion of surgical techniques was based on the treatment arms in the studies. Not all of the studies differentiated between laparoscopy and laparotomy.
The number of patients who completed the study. There were no data for patients who underwent endometrioma drainage only or hysterectomy with/without ovarian preservation.
Total number of patients
Diagnostic surgery
Sutton et al., 1997a
77.4
ND
ND
ND
ND
ND
77.4
31
31
Lesion excision
Seracchioli et al., 2010
3.6
ND
ND
ND
ND
ND
11.8 (3.6–22.2)
56
371
Darai et al., 2007
ND
8.2
ND
12.3
19.4
22.2
71
Ferrero et al., 2007
ND
ND
ND
4.4
ND
ND
68
Chapron et al., 1999
ND
17.6
ND
11.8
ND
ND
110
Davis & Brooks, 1988
6.1
ND
ND
ND
ND
ND
66
Lesion ablation
Nardo et al., 2005
11.4
ND
ND
ND
ND
ND
11.4
79
79
Pelvic denervation
Sutton et al., 1997a
6.3
ND
ND
ND
ND
ND
6.7 (5.8–15.0)
32
184
Nezhat et al., 1998
ND
15.0
6.7
ND
ND
ND
100
Nezhat & Nezhat, 1992
ND
7.7
5.8
ND
ND
ND
52
Deep endometriosis
Che et al., 2014
0.0
ND
ND
ND
ND
ND
0.0 (0.0–4.4)
63
276
Che et al., 2014
4.4
ND
ND
ND
ND
ND
45
Pereira et al., 2009
0.0
0.0
0.0
0.0
0.0
0.0
168
ND: no data.
a The number of patients who completed the study.There were no data for patients who underwent endometrioma drainage only or hysterectomy with/without ovarian preservation.
Proportion of Patients With Persistent Endometriosis-Associated Pain After Surgery
Nine studies (23.7%) reported the number of women who experienced some, but not complete, pain relief following surgery. The proportions of women who experienced incomplete relief of pain were as follows: 34.3% in the pelvic denervation group (two treatment arms; n = 87),
The number of patients who completed the study. There were no data for patients who underwent diagnostic surgery, lesion ablation surgery, endometrioma drainage only or hysterectomy with/without ovarian preservation.
Total number of patients
Lesion excision
Seracchioli et al., 2010
ND
ND
ND
ND
ND
32.1
25.0 (4.4–41.7)
56
407
Darai et al., 2007
ND
36.6
ND
29.6
23.9
35.2
71
Ferrero et al., 2007
ND
ND
ND
4.4
ND
ND
68
Chapron et al., 1999
ND
31.8
ND
22.4
ND
ND
110
Candiani et al., 1992
ND
41.7
13.9
19.4
ND
ND
36
Davis & Brooks, 1988
ND
ND
25.0
5.6
ND
ND
66
Pelvic denervation
Nezhat & Nezhat, 1992
ND
48.1
48.1
ND
ND
ND
34.3 (8.6–48.1)
52
87
Candiani et al., 1992
ND
34.3
8.6
11.4
ND
ND
35
Deep endometriosis
Che et al., 2014
ND
4.4
2.2
2.2
ND
ND
2.3 (2.2–4.4)
45
213
Pereira et al., 2009
2.4
ND
ND
ND
ND
ND
168
ND: no data.
a The number of patients who completed the study.There were no data for patients who underwent diagnostic surgery, lesion ablation surgery, endometrioma drainage only or hysterectomy with/without ovarian preservation.
Figure S1Response to therapy and symptom recurrence after surgical treatment for endometriosis.
Data are presented as median (range) or single values; median follow-up time (Figure S1C only); total numbers of women who completed the study. DE: deep endometriosis; ND: no data.
Proportion of Patients With Recurrent Endometriosis-Associated Pain
Twelve studies (31.6%) reported data on recurrence of endometriosis-associated pain following surgery. More than one half (54.8%) of the women who underwent endometrioma drainage (two treatment arms; n = 80)
experienced recurrence of pain (Table 2, online Table 5, online Figure 1C). In other treatment groups, the proportions of women who experienced pain recurrence were as follows: 28.7% in the pelvic denervation group (three treatment arms; n = 157),
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
The number of patients who completed the study. There were no data for patients who underwent diagnostic surgery, lesion ablation surgery or hysterectomy with/without ovarian preservation.
Total number of patients
Follow-up, months
Median follow-up (range), months
Lesion excision
Mossa et al., 2010
ND
6.4
2.1
2.1
15.8 (0.0–42.0)
47
921
12
22 (6.0–37.5)
Mossa et al., 2010
ND
4.7
0.0
2.3
43
12
Alborzi et al., 2004
15.8
ND
ND
ND
52
24
Fedele et al., 2004
28.0
25.3
19.3
25.3
83
37.5
Vercellini et al., 2003
ND
32.0
ND
ND
90
36
Beretta et al., 1998
ND
15.8
10.0
20
32
19.5
Donnez et al., 1997
ND
ND
3.7
1.2
242
24
Sutton et al., 1997b
30.0
ND
ND
ND
64
24
Sutton et al., 1997b
12.5
ND
ND
ND
29
36
Candiani et al., 1992
ND
42.0
42.0
ND
36
12
Davis & Brooks, 1988
7.6
ND
ND
ND
66
12
Mettler et al., 2014
ND
20.0
24.0
15.0
137
6
Endometrioma drainage
Alborzi et al., 2004
56.7
ND
ND
ND
54.8 (52.9–75.0)
48
80
24
22 (20–24)
Beretta et al., 1998
ND
52.9
52.9
75.0
32
20
Pelvic denervation
Vercellini et al., 2003
ND
36.0
ND
ND
28.7 (10.0–36.0)
90
157
36
18 (12–36)
Candiani et al., 1992
ND
34.3
23.0
ND
35
12
Sutton et al., 1997a
10.0
ND
ND
ND
32
18
Deep endometriosis
Frenna et al., 2007
7.0
ND
ND
ND
7.0
54
54
9
9
ND: no data.
a Different treatment arms within the same study are listed individually.
b The number of patients who completed the study.There were no data for patients who underwent diagnostic surgery, lesion ablation surgery or hysterectomy with/without ovarian preservation.
Twelve studies (31.6%) reported the proportion of women who required further surgery. Most women who underwent diagnostic surgery (77.4%; one treatment arm; n = 31)
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
required further surgery (Table 2, online Table 6, online Figure 2). Further surgical procedures were required by 22.6% of women after lesion excision (five treatment arms; n = 747),
Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis.
Figure S2Proportion of patients requiring further surgical treatment for endometriosis.
Data are presented as median (range) or single values; median follow-up time; total numbers of women who completed the study. DE: deep endometriosis; ND: no data.
Only one study reported outcomes following reoperation: complete resolution of disease was achieved in two patients with ureteral endometriosis in the deep endometriosis group.
Reduction in Visual Analogue Scale Score From Baseline
More than one third of studies (36.8%) reported both baseline and postoperative VAS scores for endometriosis-associated pain. The median reduction in VAS 10-cm scores from baseline to the end of follow-up (median 12 months, unless specified otherwise) was as follows: −6.2 cm in the deep endometriosis group (22 months follow-up; 11 treatment arms; n = 263),
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
When sex is not on fire: a prospective multicentre study evaluating the short-term effects of radical resection of endometriosis on quality of sex life and dyspareunia.
Change in pain and quality of life among women enrolled in a trial examining the use of narrow band imaging during laparoscopic surgery for suspected endometriosis.
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
(Table 2, online Table 7, online Figure 3). Women who underwent diagnostic surgery experienced a 0.3-cm increase in VAS score from 7.5 cm (6 months follow-up; one treatment arm; n = 31).
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Figure S3VAS score (cm) for total pain symptoms at baseline and after follow-up.
VAS scores shown as median (range). Follow-up data shown as median follow-up time (range); total numbers of women who completed the study; number of treatment arm(s). DE: deep endometriosis; VAS: visual analogue scale.
Adverse Events Following Surgery for Endometriosis
Twenty-three studies (60.5%) reported on AEs following surgery. In the pelvic denervation group (four treatment arms), 27 AEs were reported in 182 patients (AE rate, 14.8%) (Table 2, online Table 8).
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
The most common AEs in this group were severe constipation (n = 16) and urinary retention (n = 4). Rare AEs included retroperitoneal pre-sacral hematoma (n = 1), hemorrhage from the middle sacral vein (n = 1), and painless labour (n = 1). In the lesion excision group (17 treatment arms), 124 AEs were reported in 1527 patients (8.1%).
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
The most common AEs were blood loss (n = 43), postoperative fever (n = 9), and urinary retention (n = 9). Sixty-three AEs in 779 patients (8.1%) were reported in the deep endometriosis group (10 treatment arms). The most common AEs were urinary retention (n = 13), leakage of the bowel anastomosis (n = 7), and severe stenosis of the anastomosis (n = 6).
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
However, the surgical outcomes were not reported in most of the 38 clinical studies identified as relevant in this systematic review. Less than one third of studies reported the number of women without a reduction in pain, with incomplete pain relief, with recurrence of pain, or with need for further surgery. Approximately 40% of studies did not report AE data. Three studies reported that there were no complications following laparoscopy for lesion ablation, endometrioma drainage, or diagnostic surgery.
Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis.
Although laparoscopy is not without risk, it is considered to be the gold standard surgical treatment because of its lower morbidity and shorter hospital stays than laparotomy.
The available data suggest that one fourth of women who underwent lesion excision reported having some remaining endometriosis-associated pain following surgery and that, in general, more than 10% reported no improvement in pain. More than 15% of women experienced recurrent endometriosis-associated pain, and one fifth underwent further surgery. Data were insufficient to draw direct comparisons regarding the efficacy of lesion excision and ablation, although one 5-year study showed that patients were less likely to need medical therapy for endometriosis after lesion excision than after lesion ablation.
Moreover, our study does suggest that patients who receive lesion ablation therapy experience fewer AEs than patients whose lesions are excised. Similarly, only 6% of clinicians who responded to a survey thought that lesion excision is safer than lesion ablation.
Effectiveness of presacral neurectomy in women with severe dysmenorrhea caused by endometriosis who were treated with laparoscopic conservative surgery: a 1-year prospective randomized double-blind controlled trial.
In this study, uterine nerve ablation and pre-sacral neurectomy were combined into a single treatment group because of the limited number of available studies and low patient numbers. Overall, few women (6.7%) who underwent pelvic denervation reported no reduction in endometriosis-associated pain following treatment; however, one third experienced an incomplete response, and one third reported symptom recurrence. Furthermore, AEs were common in this group, with more than one half being severe constipation.
Previous studies have reported that surgical treatment of bowel deep endometriosis leads to substantial pain relief, with low recurrence rates (3% to 7%).
Consistent with this, our study showed that women with deep endometriosis have a good prognosis following surgery. Few women with deep endometriosis experienced incomplete relief or no relief of endometriosis-associated pain, recurrence of pain symptoms, or AEs after surgery. Indeed, surgical treatment of deep endometriosis provided the most benefit with respect to endometriosis-associated pain reduction as measured by VAS. However, the deep endometriosis studies were performed by experts in high-volume centres, meaning that these results may not represent the real-world expertise of gynaecologists globally and that their generalizability is limited.
In this review, patients who underwent hysterectomy with ovarian preservation were more than twice as likely to require further surgical treatment than patients who underwent hysterectomy without ovarian preservation (18.1% vs. 9.0%). It has been reported previously that, compared with bilateral oophorectomy, ovarian preservation is associated with a six-fold increase in recurrence of endometriosis-associated pain and an eight-fold greater risk of reoperation.
The findings of this study highlight the need for greater, more detailed, and more consistent reporting of the efficacy of surgical interventions for endometriosis-associated pain. We found limited data for the proportion of patients who experienced incomplete endometriosis-associated pain reduction, pain recurrence, or reoperation in the hysterectomy and lesion ablation groups. Most outcomes were reported in one third of studies or less, and evaluation of the outcomes data was difficult because of the diversity of parameters investigated. This finding is consistent with a previous systematic review in which 29 trials, 32 outcomes, and 24 measures were used to assess endometriosis-associated pain.
Such incomplete and inconsistent reporting makes it difficult to draw conclusions regarding the effectiveness and safety of these treatments. Therefore, initiatives such as Core Outcomes in Women's and Newborn Health (CROWN), which was developed to harmonize outcome reporting in women's health research, and the World Endometriosis Research Foundation (WERF) Endometriosis Phenome and Biobanking Harmonisation Project (EPHect), which was developed to standardize data and sample collection in endometriosis, are essential for progress in the future.
The medical management of endometriosis-associated pain is well recognized as a beneficial intervention either as a prelude to considering surgical management or postoperatively to prevent the recurrence of pain.
The endometriosis-associated pain VAS scores reported at baseline in this review (5.5–7.5 cm) were similar to those found in our previous systematic review exploring the treatment of endometriosis with various medical therapies (5.5–6.1 cm).
Moreover, the combined findings of our systematic reviews indicate that there is a lack of clear, consistent data concerning the long-term pain relief that patients may expect following medical or surgical treatment for endometriosis. Thus, providing women with clear, evidence-based recommendations regarding the most appropriate treatment options remains difficult.
Strengths, Limitations, and Sources of Bias in the Findings
This systematic review provides useful information on surgical practices and outcomes in women with endometriosis. However, it is important to note that this review focused on surgical interventions only. In clinical practice, physicians most commonly combine medical and surgical interventions to treat endometriosis-associated pain. It is possible, therefore, that differences in medical treatment patterns may have introduced bias in relation to the effectiveness of surgery in this review and in the source studies. Furthermore, because many of the published studies were conducted at centres of expertise specializing in endometriosis management, the findings may not be generalizable throughout the gynaecology community.
Other factors that may have influenced or biased the findings include the designs of the source studies (e.g., the presence or absence of blinding or randomization), patient characteristics, and lack of consistency among the source studies when reporting lesion locations and outcomes. Several different surgical techniques were used to treat endometriosis-associated pain, particularly in the lesion excision and deep endometriosis groups. Efficacy and AEs were not analyzed by route of surgery because the surgical technique was not consistently reported in all studies. Furthermore, the diversity of the patient cohorts, even within individual studies, is likely to have influenced our findings. For example, young age at disease onset, chronic endometriosis-associated pain, time following treatment, and more severe disease are risk factors for multiple surgical interventions for endometriosis.
Patient characteristics such as age will also have influenced the choice of surgical treatment. Although the heterogeneity of the patient population reflects clinical practice, it complicates direct comparisons across studies or treatment groups, and it may account for the wide ranges in some data. In addition, evaluation of the outcomes data was complicated because of the diversity of methods used to assess endometriosis-associated pain. Further factors impeding comparison among studies, and which could have introduced bias in the findings, include differences in follow-up times and changing standards of care over the study period.
CONCLUSION
To improve the care provided to women experiencing endometriosis-associated pain, a systematic and defined approach to the study of interventions is required. Research on the long-term effectiveness of surgery appears to be in its infancy, and, as a result, the ability to counsel women on outcomes of management is limited at this time.
Acknowledgement
The authors thank Andreas Leidenroth, PhD for assisting in the screening of article abstracts.
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Disclosures: This study was funded by Bayer AG. Dr. Singh has participated in a speakers' bureau; has received research grants and consulting fees from AbbVie, Allergan, and Bayer AG (independent of the submitted work); and has received consulting fees from Cooper Surgical. Dr. Gude is a full-time employee of Bayer AG. Dr. Perdeaux is an employee of Oxford PharmaGenesis, which received funding for both the study and medical writing services from Bayer AG. Dr. Gattrell is a former employee of Oxford PharmaGenesis, which received funding for both the study and medical writing services from Bayer AG; and is now an employee of Ipsen Pharma. Dr. Becker has received research grants from Bayer AG, independent of the submitted work, Volition RX, MDNA Life Sciences and Roche Diagnostics. He has received consultancy fees from Myovant and AbbVie and is a member of the independent data monitoring board for ObsEva. He is the current chair of the Endometriosis Guideline Development group for ESHRE. Drs. Singh and Becker have not received any payment for their participation in this work and remain independent of Bayer AG.
All authors have indicated that they meet the journal's requirements for authorship.
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