ARE WE PAYING A HIGH PRICE FOR SURGICAL SYMPATHECTOMY?
A Systematic Literature Review of Late Complications
Andrea Furlana,c MD, Angela Mailisa,bMD, MSc, FRCPC
(PhysMed) and Marios Papagapioua Msc
Comprehensive Pain Programaand Toronto
Western Hospital Research Instituteb,The Toronto Western Hospital, and Institute
for Work & Healthc, Toronto, Ontario,Canada.
INTRODUCTION
Surgical sympathectomy is performed in thousands of patients around the world primarily for the treatment of bothersome palmar hyperhidrosis.(1-7) Much less frequent indications are: neuropathic pain syndromes (like Reflex Sympathetic Dystrophy and Causalgia)(2;8;9), ischaemic conditions including peripheral vascular disease and Raynaud's phenomena (2) and rarely facial blushing (10), Prinzmetal's angina (11), as well as migraine, dysmenorrhea and pancreatitis. (2;12) Over the past couple of decades the minimally invasive endoscopic approach has gained popularity in an effort to reduce length of hospital stay and costs of the procedure. First described by Kux in 1953, it has been considered to have advantages over the traditional open approaches (better cosmetic results, good exposure of the sympathetic chain and minimal post-operative pain leading to rapid recovery) (13;14). Drott Et al (15) considered the procedure easy, fast, inexpensive and efficient and felt that the open approach will be relegated to medical history". This contrasts the experience of Hashmonai et al (16) who compared thoracoscopic versus open supraclavicular sympathectomies via a prospective randomized trial and found longer duration of anesthesia and lesser patient satisfaction in the thoracoscopic group [Hashmonai is now doing endoscopic only]. Nevertheless, immediate (perioperative and postoperative) complications (primarily for the open but lso the endoscopic approach) include: fever, hematoma, transient Horner's syndrome, bleeding, pneumothorax, infection, wound pain, lymphatic leak, chylothorax, arterial injury, brachial plexus injury, etc.(17). Late complications include: permanent Horner's syndrome, neuralgic pains, unsightly wound appearance, compensatory hyperhidrosis, gustatory sweating and phantom sweating, and in the case of bilateral Lumbar sympathectomy [often done for feet sweat only, ETS/ESB is thoracic], erectile dysfunction in the male and lack of clitoral tumescence in the female (18). Given the recent report of formation of self-support groups in Sweden for patients "suffering from complications of the procedure"(19) and the lack of systematic evaluation of the existing literature, the purpose of this literature review is to provide evidence-based assessment of: 1) current indications for surgical sympathectomy, 2) and incidence of late complications collectively and per indication.
METHODS
Operational definitions:
This review included the following surgical procedures: Upper extremities: a) Open: supraclavicular, (20-24) posterior midline, (25) paravertebral, (26;27) anterior transthoracic, (28) axillary transthoracic, (29;30) and extrathoracic with first rib Resection (31); b) Minimally invasive (Endoscopic)(32-35) with thermocoagulation or Electrocute (36) or endoscopic with laser coagulation (37); and c)Percutaneous radiofrequency or stereotactic.(11;37) Lower extremities: a) Open (38;39) with lateral or flank incision through retroperitoneal approach, (40) or anterior via transperitoneal route; (41) b) Minimally invasive (Endoscopic - retroperitoneoscopic); (42;43) and, c) percutaneous radiofrequency or stereotactic.(40)
Terms used in this review are defined as follows: Horner's syndrome is the triad of miosis, ptosis and facial anhidrosis resulting from interruption of the sympathetic outflow to the eye; Neuropathic pain refers to pain arising from injury or dysfunction of the peripheral or central nervous system. This definition is used in the current study both for a) the indications for surgical Sympathectomy and b) complications arising from it. Therefore, neuropathic pain as a term encompasses in the present study conditions reported in the literature as causalgia and reflex sympathetic dystrophy (currently called complex regional pain syndromes), nerve injury, neuralgia, neuritis and post-sympathectomy neuralgia; Primary or essential hyperhidrosis connotes excessive sweating involving primarily the palms, more pronounced in the context of emotional stimuli;(45;46) Compensatory hyperhidrosis (primarily in non denervated areas, i.e., trunk and thighs) is considered to occur after cervicodorsal sympathectomy and is called "compensatory" because of the current belief that it is a thermoregulatory reflex mediated on its efferent limb by remaining glands that still possess sympathetic innervation; (47) gustatory sweating (bilateral) and symmetrical involving the face) (48) occurs in normal individuals eating spicy (i.e., capsaicin containing) foods. Pathological gustatory sweating is seen in idiopathic hemi facial hyperhidrosis, pre or post-ganglionic sympathetic damage after sympathectomy or trauma and autonomic fiber damage within peripheral trigeminal branches; (49) Phantom sweating is a subjective feeling of "bursts" of sweating in the palms in the absence of actual sweating. It occurs after sympathectomy and is considered a symptom of residual sympathetic activity.(50)
Search Strategy
The following sources were included: *MEDLINE (Ovid) from 1966 to April 1998, using the search terms: autonomic denervation or surgical sympathectomy or ganglionectomy, AND postoperative complications, compensatory sweating, hyperhidrosis, pain, neuralgia, reflex sympathetic dystrophy, causalgia, ischemia, Horner; *EMBASE (Ovid online version) from 1980 to April 1998, with the same search strategy as for MEDLINE; *Relevant textbooks of neurosurgery, thoracic surgery, autonomic nervous system and pain. (51-57) *Screening of references in the articles and book chapters retrieved; *The Cochrane Controlled Trials Register (Cochrane Library 1998, issue 1). Study selection/ Inclusion criteria Inclusion of studies was based on the following: *Methodological issues: Studies accepted for review were randomized controlled trials, controlled clinical trials, observational studies (retrospective and prospective) or case series with more than 5 patients. Letters, commentaries and book chapters relevant to the topic of complications were included if original data about the incidence of complications were presented. The papers were in English or, if in other languages, the abstract a) was in English, and b) contained sufficient information about the topic, as described below. *Clinical issues: Only patients submitted to cervicodorsal or lumbar sympathectomy (via open, endoscopic and stereotactic approach) involving the upper or lower extremities were included. Studies selected for review had to address at least one of the following aspects related to surgical sympathectomy: 1) Complications, side-effects, late sequelae or hazards; 2) Compensatory hyperhidrosis; 3) Gustatory sweating; 4) Phantom sweating; 5) Horner's syndrome; and 6) Neuropathic pain syndromes.
Outcome measures and data extraction
The incidence of the complications was defined as "the number of patients presenting with a given complication divided by the total number of patients submitted to surgical sympathectomy". The following complications were recorded: compensatory hyperhidrosis, gustatory sweating, phantom sweating, Horner's syndrome and neuropathic pain conditions. Two authors (AF and AM) evaluated the results of the search and the inclusion criteria were applied to all studies in abstract form. Subsequently, one reviewer (AF) extracted data into an electronic database (Microsoft Excel). In case of doubt as to interpretation of data, as well as for data relating to neuropathic pain complications, original articles were reviewed by both reviewers. For each article retrieved data were extracted based on the following checklist items (detailed version of the checklist available on request): General: source, year of publication, department, language, country, type of article; Intervention: denervated body region, approach, level and method of denervation, details of surgical approach, (for example ablating the nerve of Kuntz, intervening chain, rami communicants etc.), laterality of denervation, indications; Population: number of patients and procedures, mean follow up in months, mean patient age in years, gender; Outcomes: incidence of compensatory
hyperhidrosis, gustatory sweating, phantom sweating, Horners syndrome, neuropathic pain; severity of a given complication i.e., major or minor; onset of each complication after surgery; explicit descriptions of failure of the procedure to correct the problem for which it was performed; characteristics and localization of neuropathic pain, etc. We evaluated the papers based on what we considered to be "essential" clinical elements: a) specific type of surgical approach, b) whether specific inquiry was made to the patients regarding complications, c) provision of sufficient information to enable us to classify a
given complication as minor or major, and d) duration of follow up. The assessment provided a general idea about the extent and type of information available in the existing literature. However, no papers were excluded from this review based on the above assessment, as long as they could provide relevant information.
Data analysis
The data were analyzed in order to obtain: 1) the most common indications for surgical sympathectomy in rank order; 2) demographic information about age and gender of patients; 3) the incidence rates of most common complications; and 4) the incidence of each complication according to indication. Special effort was made to detect the degree or severity of each complication. The types of surgical approach, levels of denervation, type of instruments used to interrupt the sympathetic chain, age and gender of patients we reevaluated in relation to complications. Weighted means were obtained in regards to incidence of complications using the following formula: Weighted Mean Percent= for a particular symptom of interest in the studies.(with the fraction of the sample population for a particular ailment of interest in a study, and is the actual reported number of the sample population for any symptom per given study). Since the data extracted were highly heterogeneous and represented multiple procedures, patients and indications, we avoided statistical comparisons. Obvious differences in the weighted means serve in the discussion to create "hypothesis generators" and facilitate discussion. Data duplication Certain authors published repeatedly on the same patient series. We attempted to
identify these publications. If the authors gave adequate information regarding the number of patients and the period of study, we excluded patient populations that we recognized as duplicate. When in serious doubt, certain papers were also excluded. As well, the number of procedures reported is accurate at least in representing the minimum number of procedures performed. However, it is possible that the current number of procedures reported may be slightly underestimated.
RESULTS
The MEDLINE strategy yielded 1024 articles and the EMBASE 221. The inclusion criteria were met by 135 papers. The primary reasons for the exclusion of the majority of the detected papers included: failure to mention complications, unclear information, other than limb sympathectomies and chemical instead of surgical sympathectomy. Overall, 22,458 patients and 42,061 procedures were included in this review. Since it was not possible to extract all desired data from each paper used in this review, we specify patient numbers corresponding to each important category of data. Significant problems encountered during the data extraction included: Multiplicity of approaches to surgical sympathectomy, variable methods for reporting outcomes, lack of systematic collection of data regarding complications, the variable (and frequently non existent) follow up, the non systematic reporting Of complications, and the lack of common terminology for certain conditions (i.e., neuropathic pain).
Data Synthesis
Most of the included papers were written in English (89.5%). More than half of the studies described procedures performed in the United States, United Kingdom, Taiwan and Israel (17.2%, 15.2%, 13.9% and 9.9% of the reviewed studies respectively). Only one randomized controlled trial was found in the literature comparing two surgical approaches,(16) but it was excluded from this review because the follow up of one week did not allow for emergence of late complications (data table with details of the studies available on request). The majority (115 papers or 85.8%) of the reviewed reports described non-controlled clinical trials, either retrospective or prospective, and case series, while the rest were letters, commentaries and chapters. Assessment was possible in 115 papers (Table 1) and demonstrated the following: a) The majority of the reviewed studies (89.6%) did describe the surgical procedure in detail; b) In only 30.4% of the reviewed papers were patients asked specifically about complications; c) Less than half of the studies (46.1%)reported degree of severity for compensatory hyperhidrosis only (no degree of severity could be ascertained for other complications); and d) The duration of the follow-up period was less than 12 months in19.1% of studies, more than 12 months in 53% and not provided in 27.8% of the studies. The mean age of all sympathectomized patients was 29.5 years (range 9-65, SD=10.4 years). This was obviously skewed, due to the predominance of palmar hyperhidrosis occurring in young patients, as a surgical indication. Indeed, when the indications for surgical sympathectomy were considered
separately, the average age of patients with primary hyperhidrosis, neuropathic pain and vascular disease respectively was 24.7, 36.8 and 54.0 years. While a little more than half of all sympathectomized patients (55.8%)were female, when the gender was considered separately based on the indication, the percentage of males undergoing surgical sympathectomy for primary hyperhidrosis, neuropathic pain and vascular disease was found to be 56.5%, 68.1% and 12.0% respectively. The overwhelming indication for surgical sympathectomy in 22,458 evaluable patients was primary hyperhidrosis (84.3% or 18,948 patients). The procedure for this indication was primarily bilateral. Other indications for much smaller populations were neuropathic pain (2.7% or 598 patients), vascular Ischemia (2.2% or 492 patients), Raynaud's phenomenon (0.2% or 39 patients), long QT syndrome (0.04% or 10 patients), and "unspecified/mixed" (10.2% or 2,299
patients). The latter category includes mixed surgical populations, for example neuropathic patients, ischemia patients and hyperhidrosis patients, without information about number of patients or complications per subgroup. A total of 134 articles (reporting on 22,458 evaluable patients) contained some information regarding the body region that was sympathectomized. Overall, 20,871 patients were submitted to upper extremity sympathectomy (consistent with the indication of primary hyperhidrosis), 782 to lower extremity sympathectomies and both upper and lower extremities were operated in 140 patients. In 665 patients the localization of surgical sympathectomy in the upper or lower extremity could not be ascertained. Endoscopic sympathectomy was the procedure of choice in the upper extremities (in 83.6% of the patients), while of the patients with
lower extremity procedures had open approach (77.2%). The most common levels of denervation were T2-3 (35%), T2-4 (19%) and T2 (14%) in the upper extremities and L2-4 (64%), L2-3 (18%) in the lower extremities (details of the number and combinations of denervated segments available upon request).
Most common late complications
Compensatory hyperhidrosis was reported to occur only when surgical sympathectomy was cervicodorsal. The weighted mean incidence of this complication was 52.3 % with information extracted from 17,552 patients (range 0-100% in 79 studies). (5; 10; 11; 14; 15; 17; 25; 26; 45); (58-126) Most patients had more than one surgery for palmar hyperhidrosis, while neuropathic pain patients had mostly unilateral procedure. Forty
Studies (corresponding to 5,425 patients) classified compensatory hyperhidrosis either as minor (insignificant) or major (quite disabling). In these studies, 26.3% or one quarter of patients with compensatory hyperhidrosis considered the complication major and disabling. The average time between surgical sympathectomy and the appearance of compensatory hyperhidrosis was 4 months (range 1-6 months). (82;93;118) The incidence of compensatory hyperhidrosis did not seem to be different after open or endoscopic approach. Irrespective of approach, two or more levels of denervation and removal of the stellate ganglion produced noticeably higher incidence. Finally, the incidence of this complication seemed to be 3 times higher when the surgery was performed for primary hyperhidrosis than neuropathic pain (weighted mean 52.3% vs. 18.2% respectively). Details are shown for all data in Table 2. Gender, age or specific inquiry regarding the occurrence of compensatory hyperhidrosis did not seem to affect the incidence of this complication. The weighted mean incidence of gustatory
sweating after upper extremity surgical sympathectomy was 32.3% (range 0-79) (information retrieved from 44 papers and 5,142 patients). (5; 10; 13-15; 17; 32; 60; 61; 63; 64; 67;72; 74; 76; 77; 79; 81; 82; 86-88; 94-96; 98; 103; 107; 108; 114; 115; 122; 126-137) The phenomenon appeared on average 5 months after surgery. The weighted means appeared substantially greater when the open approach was used, two or more levels were denervated, the chain was electrocoagulated but left in situ and primary hyperhidrosis was the indication for the intervention. (Table 2). Excision of the stellate ganglion, and the age or gender of the patients did not seem to substantially alter the weighted means. Unfortunately, the data did not allow us to draw conclusions about the degree of severity of this complication. The weighted mean incidence of phantom sweating was 38.6 % (range 0-59%), with data extracted from 13 papers (that specifically reported the phenomenon) and 1,539 patients. (5; 14; 17; 50; 60; 63; 67; 72; 82; 98;122;
132;136) Open surgery produced noticeably higher incidence of phantom sweating. Insufficient data regarding levels of denervation, removal or not of the stellate ganglion and primary indication did not allow us to draw conclusions about effect of these variables on the incidence. Age or gender failed to alter the incidence of phantom sweating. As with gustatory sweating, the data did not allow conclusions regarding the severity of this complication. As far as Horner's Syndrome is concerned, we encountered great variability of reporting. In some studies Horner's was considered permanent if present at the most recent follow-up, but the follow up periods were variable. The weighted mean incidence of Horner's syndrome was 2.4% (range 0-100%) (data extracted from 93 studies, 18,747 patients and 33,501 procedures). (5; 10; 11; 14; 17; 20; 25; 26; 28; 32; 37; 38; 50; 60; 62-64; 67-74; 76-79; 84-91; 93-96; 98-101; 103-110; 112-118;
120-122; 124; 131-134; 136-160) The open approach and the removal of the stellate ganglion seemed to produce a higher incidence of this complication (Table 2).The weighted mean incidence of neuropathic pain complications was 11.9% (range 0-87%),with data extracted from 37 papers and 1,979 patients (5; 11; 14; 20; 32; 37; 38; 43; 60; 65; 71; 79; 85; 89; 92; 93; 95; 103; 105; 118;120; 122; 134; 136; 141; 153; 158-167) Common descriptors for these pains were deep, dull, boring, no rhythmic.
nerves and body regions (Table 3).
No obvious differences in weighted means were observed based caching, and discomfort. Neuropathic pain complications were reported in variable ways, involving multiple on surgical approach, number of denervated levels or type of technique used. However, when surgical sympathectomy was performed for relief of neuropathic pain, for example causalgia or reflex sympathetic dystrophy, the incidence of these complications was 3 times higher than when the indication was Primary hyperhidrosis (weighted means 25.2 % and 9.8 % respectively). (Table 2). Higher incidence of neuropathic complications was noted as well if the surgery was performed in the lower extremities.
DISCUSSION
General appraisal of the literature overall, the existing literature presented us with substantial challenges and numerous difficulties. Every effort was made (see Methods) not to count patients twice in case they were reported in more than one paper. Duplicate data were found in a number of references (148/90,77/15/85,88/108,168/117)and 5 of these references were rejected (with the reported patients counted only once). Despite our efforts, it is possible that some patients were counted twice, but we do not believe this is a substantial flaw of this review, given the large numbers of patients, procedures and papers included and the small number of possible duplications. Due to the marked heterogeneity of patients, procedures, settings and indications, we avoided statistical comparisons. However, we use obvious differences in weighted means to discuss hypotheses, provoke critical thinking and formulate questions for possible future research. Our systematic review has several limitations. We point out the most serious ones: No controlled trials; One data extractor (even if most papers were reviewed by both
reviewers); Multiple surgical approaches and techniques; Unilateral and most often bilateral procedures; Several indications; Variable and at times not reported follow up periods; Lack of systematic data collection; Poorly defined and variable outcomes; Random reporting of complications (some volunteered by the patients and some after specific inquiry); Lack of common terminology (particularly in relationship to neuropathic pain), and, Data duplication in some studies. However, we feel that this systematic review, despite its serious limitations, still provides the "best available evidence" in the existing literature and points directions of future research. Given the fact that most of the existing literature is geared towards a) assessing only the effectiveness of the surgical sympathectomy procedures, and b) publishing only studies with positive results, adverse effects and complications are not systematically reported but rather as a secondary outcome. It seems, therefore, highly likely that the complications as reported here, are truly underestimated.
Specific complications and current literature beliefs
Our systematic review demonstrated that just about half of all patients who underwent surgical sympathectomy of the upper extremities, whether by open or minimally invasive approach, reported compensatory hyperhidrosis. Our findings not only demonstrate a high incidence of this complication with open surgery, but equally high incidence with the endoscopic approach, contrary to the common belief that the latter is innocuous. (14) Furthermore, more than two levels of denervation in accordance with current beliefs (47; 61; ) primary hyperhidrosis as the indication for treatment are
associated with higher incidence of this complication. The finding of high rates of compensatory hyperhidrosis specifically in patients operated for palmar hyperhidrosis may be attributed to two factors: a) the bilaterality of the procedure in most cases and b) inherent genetic vulnerability (46;47) which may make these patients prone to deregulation of sweat gland activity. The current literature, in general, has paid little attention to compensatory hyperhidrosis as a complication. Adar (169) reported that it is severe and disabling only in 1% of those patients who develop compensatory hyperhidrosis. However, our data show that the problem is indeed much more serious than currently thought, as 1 in 4 patients who develop the complication consider it disabling and worse than the reason (palmar hyperhidrosis) that led to the procedure. Our literature synthesis further shows that approximately one third of patients with cervicodorsal sympathectomy develop gustatory and phantom sweating. Adar et al (17) reported that the incidence of those two complications is fairly high (75% and 53% respectively) only if the patients are asked about it, but considered the phenomenon insignificant and not bothersome. Unfortunately, the available data do not allow us to ascertain the severity of these complications in the literature as a whole. Horner's syndrome occurred in 2.4% of all upper extremity sympathectomies. Our data support
the commonly held belief that the open approach and stellate ganglion excision increase significantly the incidence of this complication. Neuropathic pain syndromes were reported in 11.9% of all patients submitted to surgical sympathectomy in general, but seemed to affect patients 3 times more often when the surgery was performed to relieve painful neuropathic conditions than to relieve primary hyperhidrosis. The neuropathic conditions included neuralgias and neuropathies in specific nerves or nerve roots, post-sympathectomy neuralgia and unspecified neuropathic pains in body regions. We were, however, unable to extract exact information regarding the duration and evolution of these complications, nor come to any conclusions regarding the severity of these new
pains as compared to the original pain that led to the sympathectomy. The finding of high rate of neuropathic complications after surgical sympathectomy for the treatment of neuropathic painful conditions has not been reported previously. Such a high incidence (affecting 1 in 4 neuropathic pain patients) raises serious concerns regarding the appropriateness and associated dangers of surgical sympathectomy for the treatment of neuropathic pain. We hypothesize that these patients have already a vulnerable nervous system which will further react to any new trauma particularly to neural tissue. Several issues regarding sympathectomy remain open, as the objectives of this review were limited and specific. This review is geared exclusively around late complications and
does not address efficacy or effectiveness of the procedure. While the vast majority of patients were operated for palmar hyperhidrosis,the procedure is obviously used for other indications, most importantly ischemia and neuropathic pain. However, questions around satisfaction of patients with the procedure for a given indication or which approach is the best for the same indication were not asked. Similarly, we are unable to answer questions regarding completeness or permanency of the sympathetic denervation.. We did not address the issue of chemical sympathectomy, since the inclusion criteria would be more expanded (approach, neurolytic substance, volume, level etc). In general, efficacy of
both chemical and surgical sympathectomy for neuropathic pain will be addressed in another review in progress. There is large literature on sympathectomy in ischemic pain, but only the studies that fulfilled our inclusion criteria (i.e., with reference to complications) were included.
Last but not least, this review does not permit conclusions about underlying pathophysiologic mechanisms responsible for the observed complications. Is compensatory hyperhidrosis truly "compensatory" in the sense that the remaining sweat glands "overwork" to compensate for those that have been denervated? Does it occur only after cervicodorsal sympathectomy as our study suggests? In the senior author's substantial experience with neuropathic pain patients after unilateral sympathectomy, abnormal and extensive sweating has been observed within days and usually weeks in the non-sympathectomized or even the sympathectomized! extremity (despite electrophysiological confirmation of loss of sympathetic skin responses), can be seen after minor and partial nerve injuries and has occurred even in cases of lower extremity chemical sympatholysis (Mailis et al, unpublished observations). While palmar hyperhidrosis is treated usually with bilateral sympathectomy, inherent genetic vulnerability (as we discussed above) maybe contributory to the high incidence of compensatory hyperhidrosis after treatment of palmar hyperhidrosis. We suggest that the
possibility of central contribution to the deregulation of sweat gland activity may be a substantial one and should constitute the subject of future research. Furthermore, our data suggest that the presence of a dysfunctional nervous system may constitute "vulnerability" to develop further neuropathic pain syndromes. Could this vulnerability be centrally mediated as well? What is the true nature of all other phenomena observed after sympathectomy (pathological gustatory sweating and what seems to be a rather innocuous complication, phantom sweating)? These and many other questions remain currently unanswered and should constitute similarly the focus of future
research.
CONCLUSIONS, IMPLICATIONS FOR CLINICAL PRACTICEAND RECOMMENDATIONS
The sheer volume of reported procedures and patients in this review despite all its limitations, can not be ignored. The study indicates that surgical sympathectomy, irrespective of operative approach and indication, may be associated with many and potentially serious complications. A properly informed consent for the patient should include the most common complications and the incidence according to indication. Patients who are offered surgery for relief of primary hyperhidrosis should be warned that they have a high incidence of developing a different form of sweating and that if they do so, this maybe a disabling complication. Similarly, patients with painful neuropathic conditions, should be informed that they also have a significant risk of acquiring a new neuropathic pain syndrome. Our review raises questions and hypotheses. However, randomized controlled trials and well-designed clinical trials are indicated to establish
the true incidence and severity of surgical sympathectomy complications. These studies should a) employ common terminology (particularly for neuropathic pain), b) inquires specifically about complications and their severity, and c) provide appropriate follow-up to determine onset and duration of the complications. Furthermore, patient satisfaction surveys could determine the acceptance rate of sympathectomy versus the "price" one has to pay to get rid of the original indication that led to the procedure.
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