Recall bias in pain scores evaluating abdominal wall and groin pain surgery.

PURPOSE: To determine whether levels of pre-operative pain as recalled by a patient in the post-operative phase are possibly overestimated or underestimated compared to prospectively scored pain levels. If so, a subsequent misclassification may induce recall bias that may lead to an erroneous effect outcome. METHODS: Data of seven retrospective cohort studies on surgery for chronic abdominal wall and groin pain using three different pain scores were systematically analyzed. First, it was assessed whether retrospectively acquired pre-operative pain levels, as scored by the patient in the post-operative phase, differed from prospectively obtained pre-operative pain scores. Second, it was determined if errors associated with retrospectively obtained pain scores potentially lead to a misclassification of treatment outcome. Third, a meta-analysis established whether recall misclassifications, if present, affected overall study conclusions. RESULTS: Pain data of 313 patients undergoing remedial surgery were evaluated. The overall prevalence of misclassification due to a recall error was 13.7%. Patients not benefitting from surgery ('failures') judged their pre-operative pain level as more severe than it actually was. In contrast, patients who were pain free after remedial surgery ('successes') underestimated pre-operative pain scores. Recall misclassifications were significantly more present in failures than in successful patients (odds ratio 2.4 [95% CI 1.2-4.8]). CONCLUSION: One in seven patients undergoing remedial groin surgery is misclassified on the basis of retrospectively obtained pre-operative pain scores (success instead of failure, or vice versa). Misclassifications are relatively more present in failures after surgery. Therefore, the effect size of a therapy erroneously depends on its success rate.

Clinical Consensus on Diagnosis and Treatment of Patients with Chronic Exertional Compartment Syndrome of the Leg: A Delphi Analysis.

AIM: Defining universally accepted guidelines for the diagnosis and treatment of chronic exertional compartment syndrome (CECS) is hampered by the absence of high-quality scientific research. The aim of this Delphi study was to establish consensus on practical issues guiding diagnosis and treatment of CECS of the leg in civilian and military patient populations. METHODS: An international expert group was queried using the Delphi technique with a traditional three-round electronic consultation. Results of previous rounds were anonymously disclosed in the questionnaire of rounds 2 and 3, if relevant. Consensus was defined as > 70% positive or negative agreement for a question or statement. RESULTS: The panel consisted of 27 civilian and military healthcare providers. Consensus was reached on five essential key characteristics of lower leg CECS. The panel achieved partial agreement regarding standardization of the diagnostic protocol, including muscle tissue pressure measurements. Consensus was reached on conservative and surgical treatment regimens. However, the experts did not attain consensus on their approach of postoperative rehabilitation and preferred treatment approach of recurrent or residual disease. A summary of best clinical practice for the diagnosis and management of CECS was formulated by experts working in civilian and military healthcare facilities. CONCLUSION: The Delphi panel reached consensus on key criteria for signs and symptoms of CECS and several aspects for conservative and surgical treatment. The panel did not agree on the role of ICP values in the diagnostic process, postoperative rehabilitation guidelines protocol, or the preferred treatment approach for recurrent or residual disease. These aspects serve as a first attempt to initiate simple guidelines for clinical practice.

Laparoscopic mesh removal for otherwise intractable inguinal pain following endoscopic hernia repair is feasible, safe and may be effective in selected patients.

BACKGROUND: Laparoscopic inguinal hernia repair is preferred over an open technique because of reduced recovery time, favorable cost effectiveness, and less chronic postoperative inguinal pain. Nevertheless, some patients develop a nociceptive inguinal pain syndrome possibly related to the presence of the mesh. This is the first study describing feasibility, safety, and effectiveness of laparoscopic mesh removal in patients with chronic pain after endoscopic hernia repair. METHODS: Pre- and intraoperative data of chronic pain patients scheduled for endoscopic mesh removal were prospectively collected by a standard evaluation form. Long-term efficacy was determined using pain scores, patient satisfaction, and quality of life questionnaire. A Wilcoxon signed-rank test was used to determine significant differences between pre- and postoperative pain scores. RESULTS: Fourteen patients were studied (11 males, median 52 years). Median operating time was 103 min. Conversion to open surgery was not required. One intraoperatively recognized bladder laceration was laparoscopically closed. Otherwise, no intraoperative or postoperative complications occurred. Eight months postoperatively (median), pain scores had dropped from eight to four (p < 0.01). Satisfaction was good or excellent in ten patients. A recurrent hernia developed in two patients requiring an open mesh repair in one. CONCLUSIONS: Laparoscopic mesh removal is a feasible, safe, and effective option in selected patients with chronic groin pain after endoscopic hernia repair in the hands of an experienced surgeon.

Improved Adherence to a Stepped-care Model Reduces Costs of Intermittent Claudication Treatment in The Netherlands.

OBJECTIVE/BACKGROUND: A previous budget impact analysis regarding a supervised exercise therapy (SET) first treatment strategy (stepped care model [SCM]) for Dutch patients with intermittent claudication (IC) showed a low referral rate in 2009, despite solid evidence of the effectiveness of SET programs. Recently, several campaigns have stimulated stakeholders in the field to adopt a SET first strategy in patients with IC. The aim of the present study was to reassess SCM adherence after a 2 year period. METHODS: IC related invoices of patients in 2011 were obtained from a large Dutch health insurance company (3.5 million persons). Patients were divided into two groups based on their initial treatment. A SET group had started SET between 12 months before (initiated by general practitioner) and 3 months after (initiated by vascular surgeon) presentation at a vascular surgery outpatient clinic. An intervention (INT) group was treated by revascularisation within 3 months of outpatient presentation. Costs of IC treatment in this 2011 cohort were compared with the earlier 2009 cohort. RESULTS: IC related invoices of 4135 patients were available. In 2011, the initial treatment was SET in 56% (2009: 34%; +22% [p < .001]) and INT in 44% (2009: 66%; -22% [p < .001]) of the IC population. Additional revascularisation was performed in 19% of patients in the SET group (2009: 6%; +13% [p < .001]) and also in 19% of patients in the INT group (2009: 35%; -16% [p < .001]). Later on, 29% of patients in the INT group were referred for SET (2009: 10%; +19% [p < .001]). Average costs of IC treatment per patient in 2011 were 6% lower than in 2009 (€6885 vs. €7300; p = .020). CONCLUSION: A 22% increase in adherence to SET as a first treatment strategy in Dutch patients with IC was attained between 2009 and 2011. This shift suggests successful SCM implementation resulting in lower costs for the national healthcare system.

[Chronic neuralgia after knee surgery]. / Chronische zenuwpijn na een operatie aan de knie.

BACKGROUND: Chronic knee symptoms after surgery around the knee may be neuropathic. These symptoms are often described after intramedullary osteosynthesis of the lower leg, placement of total knee prosthesis and arthroscopy. This neuropathic pain may be caused by partial damage to the infrapatellar nerve. CASE DESCRIPTION: An 18-year-old patient had chronic neuropathic symptoms after intramedullary osteosynthesis of the lower leg. The diagnosis was made through physical examination and injection of lidocaine 1%. After surgical removal of the infrapatellar nerve, the patient became symptom-free for a long time. CONCLUSION: In case of chronic pain around the knee, neuropathic pain resulting from infrapatellar nerve damage should be part of the differential diagnosis. Neurectomy of the patellar nerve is a good treatment if conservative therapy did not lead to improvement of the symptoms.

Randomized clinical trial comparing self-gripping mesh with a standard polypropylene mesh for open inguinal hernia repair.

BACKGROUND: The introduction of mesh for open inguinal hernia repair has reduced the rate of recurrence, allowing research to focus on prevention of postoperative pain. In an effort to reduce chronic pain, a semiresorbable, lighter and self-gripping mesh was developed. METHODS: A double-blind randomized clinical trial was conducted comparing the self-gripping mesh with a standard polypropylene mesh repair. Patients over 18 years of age undergoing open primary hernia repair were included. Pain was measured on a six-point verbal rating scale (VRS) and a 150-mm visual analogue scale (VAS). Postoperative pain reduction from baseline pain (ΔVAS), complications and return to work/hobbies were studied. Data were collected at baseline, 3 weeks, 3 months and 1 year after surgery (primary outcome). RESULTS: A total of 363 patients were analysed. Median age was 59 (range 19-88) years. Baseline VRS and VAS scores were similar for the two groups. There was no difference in VRS scores at 1-year follow-up. Duration of surgery was significantly shorter with the self-gripping mesh (mean 40 min versus 49 min for standard mesh repair; P < 0·001). At 3 weeks, ΔVAS in patients receiving the self-gripping mesh was significantly larger (-10·6 versus -5·0 respectively; P = 0·049) and less subjective discomfort was reported (P = 0·016). Complication rates, return to work and recurrence rates were similar, although there were more recurrences in the self-gripping mesh group (5·5 versus 2·2 per cent; P = 0·103). CONCLUSION: A self-gripping mesh for hernia repair may result in less pain in the early postoperative phase but chronic postherniorraphy pain is not affected. Recurrence rates may be a potential disadvantage. REGISTRATION NUMBER: NTR1212 (http://www.trialregister.nl).

Surgery for chronic inguinodynia following routine herniorrhaphy: beneficial effects on dysejaculation.

PURPOSE: Pain during sexual activities and ejaculation is reported by 3-4% of men after routine inguinal herniorrhaphy. The potential beneficial effects of surgery for chronic groin pain on dysejaculation are unknown. The objective of this study was to determine dysejaculation rates in a series of patients reporting chronic postherniorrhaphy pain and evaluate the effects of tailored neurectomy on dysejaculation. METHODS: We evaluated male patients (>18 years) operated for chronic groin pain after inguinal herniorrhaphy during a 6-year time period (2004-2010). Dysejaculation was defined as a burning or searing sensation associated with ejaculation. Men reporting symptoms possibly associated with dysejaculation were sent a questionnaire investigating pain characteristics (VAS, 0-100), influence on sex life and effects of the tailored neurectomy. A Post-Herniorrhaphy Dysejaculation Score (PHDS, 0-12 points) was introduced to quantify the severity of the dysejaculation syndrome. RESULTS: A series of 100 males operated for chronic inguinal pain after standard herniorrhaphy were studied. Thirty-four men reported symptoms of dysejaculation prior to the tailored neurectomy. Sex life was negatively influenced in 20 of these, and 5 completely abstained from any sexual activity. Following surgery including tailored neurectomy, funicular release and/or mesh removal, VAS for dysejaculation pain was significantly reduced [n = 20, 55 (95% CI 47-63) versus 21 (95% CI 13-29), p < 0.001]. PHDS scores were also significantly attenuated [n = 20, 10 (3-12) versus 2 (0-10), p < 0.001]. Sex life normalized in two-thirds of these men (13/20). CONCLUSION: Dysejaculation in men suffering from chronic pain after routine inguinal herniorrhaphy is not uncommon. A tailored neurectomy, funicular release and/or mesh removal offer relief in the majority of these patients.

The effect of supervised exercise therapy on physical activity and ambulatory activities in patients with intermittent claudication.

OBJECTIVE/BACKGROUND: Intermittent claudication (IC) is associated with a reduction in physical activity (PA) and a more rapid functional decline leading to a higher mortality rate compared with healthy individuals. Supervised exercise therapy (SET) is known to increase the walking capacity of patients with IC. However, it is unclear whether SET increases PA. The aim of this study was to investigate the effect of SET on PA levels and ambulatory activities in patients with IC. METHODS: Patients newly diagnosed with IC were requested to wear an activity monitor 1 week prior to and 1 week immediately after 3 months of SET. The primary outcome was the percentage of patients meeting the minimum recommendations of PA (American College of Sports Medicine [ACSM]/American Heart Association [AHA] recommendation for public health of ≥ 67 metabolic equivalents [METs]/min/day, in bouts of ≥ 10 min) at baseline and after 3 months of SET. Additionally, daily PA level (METs/min), duration of ambulatory activities, daily number of steps, pain free walking distance (PFWD), maximal walking distance (MWD), and Short Form Health Survey (SF-36) health surveys were compared before and after SET. RESULTS: Data from 41 participants were available for analysis. A higher number of participants met the ACSM minimum recommendation for PA at the 3 month follow up (baseline: 43%; 3 months: 63%; p = .003). Despite significant increases in PFWD (baseline: 210 m; 3 months: 390 m; p = .001), MWD (baseline: 373 m; 3 months: 555 m; p = .002) and physical functioning score (SF-36) following SET, no increase in the mean daily PA level was found (395 ± 220 vs. 411 ± 228 METs/min; p = .43). Furthermore, the total number of steps and time spent in ambulatory activities did not change following SET. CONCLUSION: Three months of SET for IC leads to more patients meeting the ACSM/AHA public health minimum recommendations for PA. Assessment of PA could be incorporated as an outcome parameter in future research comparing different treatment modalities for peripheral arterial disease.

Long term safety and efficacy of internal carotid artery adventitial stripping in carotid sinus syndrome.

BACKGROUND: To investigate the long term efficacy of carotid denervation by adventitial stripping of the internal carotid artery (ICA) for carotid sinus syndrome (CSS). Secondly, the long term safety of this technique is investigated with emphasis on the effects on blood pressure (BP), heart rate (HR) and carotid artery diameter. METHODS: Characteristics of patients that were operated for CSS in a single institute between 1980-2007 were studied by a retrospective chart review. Alive and fit patients additionally received a standardized interview investigating symptoms of residual CSS or baroreflex failure. They underwent a test panel consisting of office BP measurement, carotid sinus massage (CSM), table tilt testing, 24-hour ECG and ambulatory BP measurement (ABPM) and carotid duplex. Unoperated, age- and sex- matched individuals without CSS served as controls. RESULTS: After a total follow up of 91±34 months, 22 of 26 patients (85%) were asymptomatic and 20 of them (77%) without a pacemaker. Of the 7 surviving and fit patients, six were free of CSS symptoms (follow up 114 ± 81 months). Recurrence of CSS after an initial successful carotid denervation was not observed. BP level, BP variability and carotid diameters were not different compared to controls. CONCLUSION: Carotid denervation by adventitial stripping of the ICA for CSS seems effective and safe on the long term. A randomized controlled trial comparing the efficacy and safety of carotid denervation, pacing and medical treatment is needed for optimal future treatment of patients suffering from CSS.

Physical activity monitoring in patients with peripheral arterial disease: validation of an activity monitor.

OBJECTIVES: The daily life physical activity (PA) of patients with peripheral arterial disease (PAD) may be severely hampered by intermittent claudication (IC). From a therapeutic, as well as research, point of view, it may be more relevant to determine improvement in PA as an outcome measure in IC. The aim of this study was to validate daily activities using a novel type of tri-axial accelerometer (Dynaport MoveMonitor) in patients with IC. METHODS: Patients with IC were studied during a hospital visit. Standard activities (locomotion, lying, sitting, standing, shuffling, number of steps and "not worn" detection) were video recorded and compared with activities scored by the MoveMonitor. Inter-rater reliability (expressed in intraclass correlation coefficients [ICC]), sensitivity, specificity, and positive predictive values (PPV) were calculated for each activity. RESULTS: Twenty-eight hours of video observation were analysed (n = 21). Our video annotation method (the gold standard method) appeared to be accurate for most postures (ICC > 0.97), except for shuffling (ICC = 0.38). The MoveMonitor showed a high sensitivity (>86%), specificity (>91%), and PPV (>88%) for locomotion, lying, sitting, and "not worn" detection. Moderate accuracy was found for standing (46%), while shuffling appeared to be undetectable (18%). A strong correlation was found between video recordings and the MoveMonitor with regard to the calculation of the "number of steps" (ICC = 0.90). CONCLUSIONS: The MoveMonitor provides accurate information on a diverse set of postures, daily activities, and number of steps in IC patients. However, the detection of low amplitude movements, such as shuffling and "sitting to standing" transfers, is a matter of concern. This tool is useful in assessing the role of PA as a novel, clinically relevant outcome parameter in IC.

Significant savings with a stepped care model for treatment of patients with intermittent claudication.

OBJECTIVES: International guidelines recommend supervised exercise therapy (SET) as primary treatment for intermittent claudication (IC). The aim of this study was to calculate treatment costs in patients with IC and to estimate nationwide annual savings if a stepped care model (SCM, primary SET treatment followed by revascularization in case of SET failure) was followed. METHODS: Invoice data of all patients with IC in 2009 were obtained from a Dutch health insurance company (3.4 million members). Patients were divided into three groups based on initial treatment after diagnosis (t0). The SET group received SET initiated at any time between 12 months before and up to 3 months after t0. The intervention group (INT) underwent endovascular or open revascularization between t0 and t+3 months. The third group (REST) received neither SET nor any intervention. All peripheral arterial disease related invoices were recorded during 2 years and average costs per patient were calculated. Savings following use of a SCM were calculated for three scenarios. RESULTS: Data on 4954 patients were analyzed. Initial treatment was SET (n = 701, 14.1%), INT (n = 1363, 27.5%), or REST (n = 2890, 58.3%). Within 2 years from t0, invasive revascularization in the SET group was performed in 45 patients (6.4%). Additional interventions (primary at other location and/or re-interventions) were performed in 480 INT patients (35.2%). Some 431 REST patients received additional SET (n = 299, 10.3%) or an intervention (n = 132, 4.5%). Mean total IC related costs per patient were €2,191, €9851 and €824 for SET, INT, and REST, respectively. Based on a hypothetical worst, moderate, and best case scenario, some 3.8, 20.6, or 33.0 million euros would have been saved per annum if SCM was implemented in the Dutch healthcare system. CONCLUSION: Implementation of a SCM treatment for patients with IC may lead to significant savings of health care resources.

Editor's choice--The effect of supervision on walking distance in patients with intermittent claudication: a meta-analysis.

BACKGROUND: A number of reviews have reported the influence of exercise therapy (ET) for the treatment of intermittent claudication (IC). However, a complete overview of different types of ET is lacking. The aim of this meta-analysis was to study the effect of supervision on walking capacity in patients with IC. It was hypothesized that there was a positive treatment effect in relation to the intensity of supervision and improvement in walking capacity (i.e., a "dose-response" hypothesis). METHODS: A systematic search in the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases was performed. Only randomized controlled trials (RCTs) evaluating the efficacy of an ET in IC were included. Type of supervision, treadmill protocol, length of ET, total training volume, and change in walking distance were extracted. RCTs were categorised according to type of support: no exercise, walking advice, home-based exercise (HB-ET), and supervised exercise therapy (SET). A standardised mean difference between pre- and post-training maximal walking distance (MWD) and pain-free walking distance (PFWD) was calculated for all subgroups at 6 weeks, and 3 and 6 months of follow up. RESULTS: Thirty studies involving 1406 patients with IC were included. The overall quality was moderate-to-good, although number of included patients varied widely (20-304). The intensity of supervision was directly related to MWD and PFWD. SET was superior to other conservative treatment regimens with respect to improvement in walking distances at all follow-ups. However, the difference between HB-ET and SET at 6 months of follow up was not significant. CONCLUSION: Supervised exercise therapy for intermittent claudication is superior to all other forms of exercise therapy. Intensity of supervision is related to improved walking distance.

Physical activity monitoring in patients with intermittent claudication.

OBJECTIVES: Reduced physical activity (PA) is associated with a higher mortality rate and more rapid functional decline in patients with intermittent claudication (IC). The newest generation of accelerometers can assess both direction and intensity of activities three-dimensionally and may also adequately calculate energy expenditure in daily life. The aim of this study was to quantify daily PA level and energy expenditure of newly diagnosed patients with IC and healthy controls. PA outcomes are compared with contemporary public health physical activity guidelines. METHODS: Before initiating treatment, 94 patients with newly diagnosed IC and 36 healthy controls were instructed to wear a tri-axial seismic accelerometer for 1 week. Daily PA levels (in metabolic equivalents, METs) were compared with the ACSM/AHA public health PA minimum recommendations (≥64 METs·min·day, in bouts of ≥10 minutes). A subgroup analysis assessed the effect of functional impairment on daily PA levels. RESULTS: Data from 56 IC patients and 27 healthy controls were available for analysis. Patients with IC demonstrated significantly lower mean daily PA levels (±SD) than controls (387 ± 198 METs·min vs. 500 ± 156 METs·min, p = .02). This difference was solely attributable to a subgroup of IC patients with the largest functional impairment (WIQ-score < 0.4). Only 45% of IC patients met the public health physical activity guidelines compared with 74% of the healthy controls (p = .01). CONCLUSIONS: More than half of patients with IC do not meet recommended standards of PA. Considering the serious health risks associated with low PA levels, these findings underscore the need for more awareness to improve physical exercise in patients with IC.

A randomised controlled trial of injection therapy versus neurectomy for post-herniorrhaphy inguinal neuralgia: rationale and study design.

BACKGROUND: Chronic inguinal neuralgia is considered to be an important complication after hernia repair. As a high-level evidence-based treatment regime is currently lacking, these patients usually receive a random combination of pain medication, local nerve blocks or an occasional surgical neurectomy. A controlled trial ('GroinPain Trial') was constructed to identify the optimal treatment modality in this population. The aim and rationale of the trial are presented in this paper. PATIENTS AND METHODS: Adult patients with chronic post-herniorrhaphy inguinal pain (>3 months) caused by inguinal nerve entrapment having a temporary pain reduction after a lidocain nerve block are eligible for randomisation. They received either repetitive nerve blocks with lidocain, corticosteroids and hyaluronic acid, or a 'tailored' surgical neurectomy. RESULTS: Patient enrollment started in February 2006 and is expected to end in June 2010. The initial results will be available at the end of 2010. CONCLUSIONS: This trial is the first randomised controlled effort comparing two invasive treatment modalities for peripheral inguinal nerve entrapment. As awareness and knowledge on chronic neuropathic pain after inguinal herniorrhaphy in the near future is expected to increase, the findings of this trial will aid in optimising care in this patient population.

Harlequin syndrome: two new cases and a management proposal.

The Harlequin syndrome is a rare autonomic disorder, characterized by unilateral diminished sweating and flushing of the face in response to heat or exercise. We present two new cases and evaluate the data of 83 patients described in the literature. We provide diagnostic and therapeutic guidelines.

Adventitial stripping for carotid sinus syndrome.

Patients with a carotid sinus syndrome (CSS) suffer from spells of dizziness and loss of conscience due to an exaggerated carotid baroreflex response. Three types of the syndrome are described: cardioinhibitory, vasodepressor and a mixed form. The gold standard for treatment is insertion of a pacemaker, but this therapy may be effective only in a pure cardioinhibitory type. In contrast, surgically interrupting afferent nerves at the origin may offer relief of symptoms in all three types. The present review analyzes the results of a surgical technique termed "adventitial stripping" of the carotid sinus. Data from 130 procedures demonstrate that carotid denervation is effective in 85% of CSS cases with low complication rates. Postoperative monitoring is mandatory as transient alterations in blood pressure and heart rate may occur.

Effective surgical treatment of the carotid sinus sindrome.

Elderly patients frequently suffer from dizziness and syncope; however, an underlying disease may not always be identified. Three patients aged 69, 71 and 56, respectively, experienced spells of dizziness and syncope. Massage of the carotid sinus demonstrated the presence of a carotid sinus syndrome (CSS), an abnormal baroreflex response of the carotid sinus that leads to asystole and extreme hypotension. Conventional treatment is generally by insertion of a pacemaker. These patients, however, were referred to the vascular surgery department of our hospital for removal of adventitial layers of proximal portions of the internal carotid artery. Recovery was uneventful; all three are now free of symptoms. CSS should be considered in the differential diagnosis of dizziness and syncope. Surgical denervation of the carotid artery is a valid treatment option, especially in the vasodepressive or mixed type of CSS.