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.

Laparoscopic mesh removal for chronic postoperative inguinal pain following endoscopic hernia repair: a cohort study on the effect on pain.

PURPOSE: Chronic postoperative inguinal pain (CPIP) after pre-peritoneal hernia repair is rare but may be severely invalidating. Mesh may be a contributing factor to the development of CPIP. International guidelines acknowledge mesh removal as a treatment option for CPIP after open repair, but experience in laparoscopic mesh removal is limited. Surgeons are hesitant to remove pre-peritoneal meshes because of fear of operative complications. This observational study describes risks and effectiveness of laparoscopic mesh removal in patients with CPIP after endoscopic inguinal hernia repair. METHODS: Questionnaires and operative findings of consecutive patients undergoing a laparoscopic mesh removal for CPIP between August 2014 and February 2019 in the center for groin pain were prospectively recorded. Long-term efficacy was determined using pre and postoperative questionnaires on pain and quality of life. RESULTS: Forty-four patients were included (37 males, median age 51 years). Complete or sufficient pain relief was reported in every two out of three patients (68%) and quality of life improved significantly. Intraoperative findings included wrinkled mesh (n = 19), meshoma (n = 14) and infected mesh (n = 1). Surprisingly, over half of the meshes (n = 23) did not fully cover the groin, with three clear recurrent hernias. Intraoperative complications included two bladder injuries. One patient undergoing removal of 3 meshes on one side developed a necrotic testicle. During follow-up, three patients developed a recurrent hernia requiring open surgery. CONCLUSION: Laparoscopic mesh removal is safe and effective in selected patients with CPIP after endoscopic hernia repair. We believe that this technique should be adopted by dedicated hernia surgeons.

A decade of litigation regarding surgical informed consent in the Netherlands.

OBJECTIVE: An inadequate surgical informed consent process (SIC) may result in a medical malpractice claim or medical disciplinary board (MDB) complaint. Aim of this study was to analyse characteristics of a decade of malpractice claims and MDB decisions regarding SIC in the Netherlands. METHODS: A retrospective analysis of malpractice claims and MDB decisions concerning SIC disputes in four major surgical specialties was conducted based on company data from the largest medical malpractice insurance company and two public available online MDB databases. RESULTS: A total of 11376 malpractice claims and 661 MDB complaints were filed between 2004-2013 and 676(6%) of these claims and 69(10%) of these complaints involved an alleged deficient SIC process. A random sample of 245(37%) claims and all MDB decisions were analysed. Reasons for filing a claim or complaint were insufficient counselling or recording of SIC elements. In 20% of lawsuits and 25% of claims the case resulted in favour of the complainant. CONCLUSION: A substantial portion of malpractice claims and MDB decisions is related to a deficient SIC process. PRACTICE IMPLICATIONS: Focusing on crucial SIC elements for patients may improve satisfaction and expectations and result in a lower risk for malpractice claims and MDB complaints.

Bilateral breast calciphylaxis in a patient who survived earlier extensive tissue necrosis 5 years previously: A case report.

INTRODUCTION: Calciphylaxis is a rare condition including patchy dermal necrosis that mostly affects chronic hemodialysis patients. The syndrome usually heralds impending death although patients may survive following a set of measures including an adapted dialysis regimen. The present case is a unique patient who recovered from an earlier episode of upper leg calciphylaxis 5 years previously but developed fatal bilateral breast necrosis. PRESENTATION OF CASE: A 69 year old Caucasian woman with a history of atrial fibrillation, hypertension, CVA, hyperparathyroidectomy for secondary hyperparathyroidism and end stage renal disease with hemodialysis recovered in 2012 from extensive symptomatic left upper leg necrosis due to calciphylaxis. In 2017, she developed painful, necrotic ulcers on both breasts, again due to calciphylaxis. She had no history of anticoagulants use but she did use prednisolone 5mg/day. She received adequate wound care, pain medication, antibiotics and dialysis frequency was increased with an addition of sodium thiosulfate. A bilateral ablation was discussed but she decided to stop all treatment following pulmonary aspiration and passed away one week later. DISCUSSION: Calciphylaxis is a rare diagnosis that should be considered in patients with renal insufficiency developing painful patches of skin necrosis. CONCLUSION: A multidisciplinary treatment approach including hyperparathyroidectomy, modified hemodialysis and wound treatment is recommended. There is limited evidence for surgical intervention.

Anterior cutaneous nerve entrapment syndrome (ACNES).

The abdominal wall is frequently overlooked as a potential source of chronic abdominal pain. In anterior cutaneous nerve entrapment syndrome (ACNES), irritated intercostal nerves cause severe abdominal pain. Current textbooks fail to acknowledge ACNES. Aim of the present review is to provide detailed information on patient history, physical examination, and a three-step treatment protocol including abdominal wall injections and a localized removal of terminal branches of intercostal nerves.

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.

Venous Side Branch Ligation as a First Step Treatment for Haemodialysis Access Induced Hand Ischaemia: Effects on Access Flow Volume and Digital Perfusion.

OBJECTIVE: Haemodialysis access induced distal ischemia (HAIDI) induced by an autogenous arteriovenous fistula (AVF) is caused by loss of blood pressure somewhere along the arterial blood supply of the arm. In some patients, side branches of the access' venous outflow tract may contribute to this blood pressure loss. Beneficial effects of side branch ligation (SBL) as a first step approach to ischemic symptoms have been reported. However, effects on access flow and AVF function after prolonged follow up are unknown. MATERIALS AND METHODS: Prior to SBL, HAIDI patients with a brachial artery based AVF were studied using a questionnaire quantifying hand ischemia, digital brachial index (DBI, finger plethysmography), and Duplex analysis. Access flow volume, patency rates, hand perfusion, and complications were determined during a 12 month observation period following SBL. RESULTS: In 9 years, SBLs were performed in 20 haemodialysis patients, either as a single operative procedure (n = 10) or supplemented (n = 10) with additional surgical techniques during the same procedure (banding, n = 5; basilic vein transposition, n = 4; DRIL, n = 1). Follow up data after 12 months were available in 18 patients. One patient with progressive hand ischemia required access ligation 3 months after SBL. Hand ischemia was attenuated or abolished in the remaining 17 patients (94% clinical success rate). DBI improved from 0.51 ± 0.05 (pre-operative) to 0.68 ± 0.04 (immediate post-operative) and 0.83 ± 0.07 (at 1 year follow up). One year primary, assisted primary, and secondary patency rates were 67% (12/18), 83% (15/18), and 94% (17/18), respectively, while mean access flows remained acceptable at 710 ± 70 mL/min. CONCLUSIONS: Ligation of non-functional venous side branches of an autogenous brachial artery AVF causing hand ischemia leads to prolonged attenuation of hand ischemia whereas access flow volumes are maintained after 1 year of follow up. Side branch ligation must be considered prior to embarking on more invasive surgery for HAIDI.

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.

Surgical options after a failed neurectomy in anterior cutaneous nerve entrapment syndrome.

BACKGROUND: Injection treatment followed by an anterior neurectomy in patients insufficiently responding to an injection regimen is successful long term in three-quarters of patients with anterior cutaneous nerve entrapment syndrome (ACNES). The efficacy of secondary surgery, including re-exploration or a posterior neurectomy in patients reporting recurrent pain after initially successful surgery or following an immediately failed anterior neurectomy is unknown. METHODS: A database of ACNES patients receiving surgery between 2004 and 2012 in the SolviMáx institution was analysed. Adult patients with residual pain after an anterior neurectomy (failures) or with recurrent pain after initially successful surgery (recurrences) were selected. Following a re-exploration or a posterior neurectomy, pain was scored using a pain intensity numeric rating scale (PI-NRS 0-10) and a six-point verbal category rating scale (VRS). Success was defined as a ≥50 % PI-NRS reduction and/or ≥2 point VRS reduction. RESULTS: ACNES patients undergoing an anterior neurectomy (n = 181) were analysed during the 8-year study period. At follow-up, 51 patients reported unacceptable pain levels following an anterior neurectomy, whereas 20 developed recurrent abdominal wall pain. Of these 71 unsuccessful patients, 41 underwent secondary surgery, including a re-exploration (n = 10), or a posterior neurectomy (n = 31). After a 25-month median follow-up, secondary surgical treatment regimens proved successful in 66 % (27/41). Patients with recurrent pain did better (14/15) than patients who were immediate failures after the anterior neurectomy (13/26, p = 0.01). CONCLUSIONS: Secondary surgery including re-explorations and posterior neurectomies are successful in two-thirds of ACNES patients with persistent pain or recurrence of pain after an anterior neurectomy.

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.