Thoracoscopic oesophageal atresia/tracheo-oesophageal fistula (OA/TOF) repair is associated with a higher stricture rate: a single institution's experience.

PURPOSE: Thoracoscopic OA/TOF repair was first described in 1999. Currently, less than 10% of surgeons routinely employ minimally access surgery. Our primary aim was to review our immediate-, early- and long-term outcomes with this technique compared with the open approach. METHODS: A retrospective review of all patients undergoing primary OA/TOF (Type C) repair at our institution from 2009 was conducted. Outcome measures included length of surgery, conversion rate from thoracoscopy, early complications such as anastomotic leak and post-operative complications such as anastomotic strictures needing dilatations. Fisher's exact and Kruskal-Wallis tests were used for statistical analysis. RESULTS: 95 patients in total underwent OA/TOF repair during the study period of which 61 (64%) were completed via an open approach. 34 were attempted thoracoscopically of which 11 (33%) were converted. There was only one clinically significant anastomotic leak in our series that took place in the thoracoscopic group. We identified a significantly higher stricture rate in our thoracoscopic cohort (72%) versus open surgery (43%, P < 0.05). However, the median number of dilations (3) performed was not significantly different between the groups. There was one recurrent fistula in the thoracoscopic converted to open group. Our median follow-up was 60 months across the groups. CONCLUSION: In our experience, the clinically significant leak rate for both open and thoracoscopic repair as well as recurrent fistula is much lower than has been reported in the literature. We do not routinely perform contrast studies and are, thus, reporting clinically significant leaks only. The use of post-operative neck flexion, ventilation and paralysis is likely to be protective towards a leak. Thoracoscopic OA/TOF repair is associated with a higher stricture rate compared with open surgery; however, these strictures respond to a similar number of dilatations and are no more refractory. Larger, multicentre studies may be useful to investigate these finding further.

Quality and effectiveness of osteoporosis treatment decision aids: a systematic review and environmental scan.

Decision aids (DAs) are evidence-based tools that support shared decision-making (SDM) implementation in practice; this study aimed to identify existing osteoporosis DAs and assess their quality and efficacy; and to gain feedback from a patient advisory group on findings and implications for further research. We searched multiple bibliographic databases to identify research studies from 2000 to 2019 and undertook an environmental scan (search conducted February 2019, repeated in March 2020). A pair of reviewers, working independently selected studies for inclusion, extracted data, evaluated each trial's risk of bias, and conducted DA quality assessment using the International Patient Decision Aid Standards (IPDAS). Public contributors (patients and caregivers with experience of osteoporosis and fragility fractures) participated in discussion groups to review a sample of DAs, express preferences for a new DA, and discuss plans for development of a new DA. We identified 6 studies, with high or unclear risk of bias. Across included studies, use of an osteoporosis DA was reported to result in reduced decisional conflict compared with baseline, increased SDM, and increased accuracy of patients' perceived fracture risk compared with controls. Eleven DAs were identified, of which none met the full set of IPDAS criteria for certification for minimization of bias. Public contributors expressed preferences for encounter DAs that are individualized to patients' own needs and risk. Using a systematic review and environmental scan, we identified 11 decision aids to inform patient decisions about osteoporosis treatment and 6 studies evaluating their effectiveness. Use of decision aids increased accuracy of risk perception and shared decision-making but the decision aids themselves fail to comprehensively meet international quality standards and patient needs, underpinning the need for new DA development.

Unmet needs in ankylosing spondylitis patients receiving tumour necrosis factor inhibitor therapy; results from a large multinational real-world study.

BACKGROUND: Symptoms and comorbidities of ankylosing spondylitis (AS) considerably reduce health-related quality of life (HRQoL) and ability to work. This real-world study assessed rates of tumour necrosis factor inhibitor (TNFi) use and switching, treatment failure, and associations between failing TNFi and HRQoL, work productivity and activity impairment (WPAI). METHODS: AS patients and their treating physicians completed questionnaires capturing patient demographics, clinical status, TNFi treatment history, reasons for switching TNFi, HRQoL and WPAI. Current TNFi was determined as "failing" if, after ≥3 months, physician-rated disease severity had worsened, remained severe, was "unstable/deteriorating", physicians were dissatisfied with disease control and/or did not consider treatment a "success". RESULTS: The analysis included 2866 AS patients from 18 countries. Of 2795 patients with complete treatment data, 916 (32.8%) patients had never received TNFi therapy, 1623 (58.1%) patients were receiving their 1st TNFi and 200 (7.2%) patients had ever received ≥2 TNFi (treatment switch). Primary or secondary lack of efficacy were the commonest reasons for switching, and the mean delay in switching after primary lack of efficacy was 11.1 months. 232 (15.4%) patients on TNFi were currently "failing" who, compared to those with treatment success, reported poorer HRQoL: 5-dimension EuroQoL (EQ-5D-3 L): 0.63 vs. 0.78; Medical Outcomes Study Short-Form Health Survey version 2 (SF-36v2) mental component summary (MCS): 41.8 vs. 46.3; physical component summary (PCS): 40.2 vs. 45.1; impaired work productivity: 46.4% vs. 25.0%; and activity: 44.5% vs. 29.6%; all P < 0.001. CONCLUSIONS: Among AS patients, switching TNFi is uncommon and delayed by nearly 1 year despite primary lack of efficacy. Patients currently failing TNFi experience worse physical function, HRQoL and work productivity.

Unmet needs in psoriatic arthritis patients receiving immunomodulatory therapy: results from a large multinational real-world study.

OBJECTIVE: There are limited data on therapy selection and switching in psoriatic arthritis (PsA). This 18 country, real-world study assessed use and switching of immunomodulatory therapy (biologic/apremilast), the extent of treatment failure and its association with reduced physical functioning, health-related quality of life (HRQoL), and work productivity and activity impairment (WPAI). METHODS: PsA patients under routine care and their treating physicians provided demographics, current therapy, reasons for switching, duration of first therapy, HRQoL, HAQ-DI, and WPAI. Current immunomodulatory therapy was determined as "failing" if, after ≥ 3 months, physician-rated disease severity had worsened, remained severe, was "unstable/deteriorating," or they were dissatisfied with disease control and/or did not consider treatment a "success." RESULTS: Included were 3714 PsA patients; 1455 (40.6%) had never received immunomodulatory therapy; 1796 (50.1%) had ever received 1 immunomodulatory therapy and 331 (9.2%) ≥ 1. Lack of efficacy with first immunomodulatory therapy was the most common reason for switching; patients whose physicians indicated "primary lack of efficacy" as the reason, switched after a mean of 9.4 months. Patients currently failing immunomodulator therapies (n = 246) had poorer HRQoL compared with treatment success (n = 1472) measured by EQ-5D-3L (0.60 vs 0.77%; P < 0.0001); SF-36 PCS (40.8% vs 46.1%; P < 0.0001) MCS (41.1% vs 45.3%; P < 0.0001). Physical functioning, activity, and work productivity were also more impaired (HAQ-DI: 0.88 vs 0.56; activity impairment: 46.7% vs 29.7%; overall work impairment: 35.4% vs 26.1%; all P < 0.0001). CONCLUSIONS: Poor treatment response in PsA is associated with substantial negative patient impact. In cases of primary treatment failure, timely switching is needed.

The multi-disciplinary management of complex congenital and acquired tracheo-oesophageal fistulae.

AIM OF THE STUDY: Complex tracheo-oesophageal fistulae (TOF) are rare congenital or acquired conditions in children. We discuss here a multidisciplinary (MDT) approach adopted over the past 5 years. METHODS: We retrospectively collected data on all patients with recurrent or acquired TOF managed at a single institution. All cases were investigated with neck and thorax CT scan. Other investigations included flexible bronchoscopy and bronchogram (B&B), microlaryngobronchoscopy (MLB) and oesophagoscopy. All cases were subsequently discussed in an MDT meeting on an emergent basis if necessary. MAIN RESULTS: 14 patients were referred during this study period of which half had a congenital aetiology and the other half were acquired. The latter included button battery ingestions (5/7) and iatrogenic injuries during oesophageal atresia (OA) repair. Surgical repair was performed on cardiac bypass in 3/7 cases of recurrent congenital fistulae and all cases of acquired fistulae. Post-operatively, 9/14 (64%) patients suffered complications including anastomotic leak (1), bilateral vocal cord paresis (1), further recurrence (1), and mortality (1). Ten patients continue to receive surgical input encompassing tracheal/oesophageal stents and dilatations. CONCLUSIONS: MDT approach to complex cases is becoming increasingly common across all specialties and is important in making decisions in these difficult cases. The benefits include shared experience of rare cases and full access to multidisciplinary expertise.

What Exactly is Meant by "Loss of Domain" for Ventral Hernia? Systematic Review of Definitions.

Large ventral hernias are a significant surgical challenge. "Loss of domain" (LOD) expresses the relationship between hernia and abdominal volume, and is used to predict operative difficulty and success. This systematic review assessed whether different definitions of LOD are used in the literature. The PubMed database was searched for articles reporting large hernia repairs that explicitly described LOD. Two reviewers screened citations and extracted data from selected articles, focusing on the definitions used for LOD, study demographics, study design, and reporting surgical specialty. One hundred and seven articles were identified, 93 full-texts examined, and 77 were included in the systematic review. Sixty-seven articles were from the primary literature, and 10 articles were from the secondary literature. Twenty-eight articles (36%) gave a written definition for loss of domain. These varied and divided into six broad groupings; four described the loss of the right of domain, six described abdominal strap muscle contraction, five described the "second abdomen", five describing large irreducible hernias. Six gave miscellaneous definitions. Two articles gave multiple definitions. Twenty articles (26%) gave volumetric definitions; eight used the Tanaka method [hernia sac volume (HSV)/abdominal cavity volume] and five used the Sabbagh method [(HSV)/total peritoneal volume]. The definitions used for loss of domain were not dependent on the reporting specialty. Our systematic review revealed that multiple definitions of loss of domain are being used. These vary and are not interchangeable. Expert consensus on this matter is necessary to standardise this important concept for hernia surgeons.

When might an operative complication be regarded as acceptable? Part 2: Judicial factors that influence the finding of fault during surgical litigation.

In cases where surgeons face litigation over operative misadventure, the result of a trial is uncertain. In order to identify factors in cases of surgical litigation that have influenced the final decision of the courts, we have previously reviewed reported cases where the outcome turned on actions taken by surgeons. We now turn our attention to judicial attitudes to evidence that play a role in the determination of the case.

When might an operative complication be regarded as acceptable? Part 1: Surgical factors that influence courts when finding fault during litigation.

In cases where surgeons face litigation over operative misadventure, the result of a trial is uncertain. In order to identify factors in cases of surgical litigation that have influenced the final decision of the courts, we have reviewed recent reported cases, noting both surgical and evidential influences on outcome. Taken together, these reveal that among other influential factors, the acceptability of more than one reasonable operative approach, the court's approach to inappropriate delegation and the uncertainties of expert evidence all play a role in the determination of the case.

An unlikely cause of severe malnutrition in a 3-year-old girl with previous gastroschisis.

A 3-year-old girl with previous gastroschisis associated with jejunal and colonic atresia presented with severe oedema, abdominal pain and diarrhoea. Clinically she was malnourished. Serum albumin and concentrations of micronutrients were low. A barium meal examination showed jejunal dilation. A stricture was suspected and the patient was taken to theatre where an 8 cm length of bowel was resected including a jejunal stricture at the point of previous atresia repair. Inside the proximal dilated jejunum was a large trichobezoar (hairball), thought to be acting as a ball valve inside the bowel. This girl made a rapid recovery after surgery. Her nutritional state improved, symptoms resolved and serum biochemistry normalised. She remains well at follow-up with normal blood results, normal albumin and no diarrhoea.

Seeking responsibility for the lost swab? Search elsewhere.

This article explores the possibility that the surgeon's control over his or her environment is not complete and that, in certain circumstances, the final swab count can be distinguished from the 'normal course of events'. We readily accept that most swabs and instruments are left inside patients simply as a result of substandard care but we cannot accept that this is invariably the case, and lessons from the common law are cited to illustrate the reasons why. We hope to persuade defendant lawyers that it might be worthwhile to tease out from surgeons under scrutiny how these factors may have influenced their practice on the day that a swab was retained.

Surgery for children with Crohn's disease: indications, complications and outcome.

BACKGROUND: Outcome data for surgery in paediatric Crohn's disease are limited. We report 10 years' experience at a regional paediatric gastroenterology centre. METHODS: Children undergoing surgery for Crohn's disease (January 2002-December 2012) were identified from an onsite patient register. Patients were followed until transition to adult services. Data were obtained from medical records and are expressed as median (range). RESULTS: Sixty-nine children, aged 13.8 years (6.3-17.0) at diagnosis, were included. 42 were male (61%). Follow-up was 1.8 years (27 days-6 years). Surgery followed diagnosis by 9 months (0 days-7 years). 52 children (75%) received thiopurines and 5 (7%) anti-TNF (tumour necrosis factor) therapy preoperatively. 58 (84%) underwent intra-abdominal surgery (40 right hemicolectomy, 8 stoma formation, 2 subtotal colectomy, 2 small bowel resection, 6 other) and 10 (14%) underwent surgery for perianal disease. The commonest indications for intra-abdominal surgery were stricturing disease 35 (60%) and unresponsive luminal disease 13 (22%). There were 13 (22%) early, and 5 (8.6%) late, complications following intra-abdominal surgery. Nine children had disease relapse, five required further surgery. Height SD scores (SDS) did not increase between diagnosis; -0.5 (-3.4-2.1) and most recent follow up; -0.4 (-3.0-1.1). Body Mass Index (BMI) SDS increased from -1.0 (-6.3-1.5) to -0.3 (-3.3-2.0) (p<0.05). CONCLUSIONS: Surgery was associated with a 22% early complication rate and a 15% risk of relapse. 21% of patients required a second unplanned intra-abdominal procedure. Surgical intervention was associated with an increase in BMI SDS, but not in height SDS.

Intravesical botulinum type-A toxin (Dysport®) in the treatment of idiopathic detrusor overactivity in children.

OBJECTIVE: Botulinum type-A toxin is increasingly used for refractory idiopathic detrusor overactivity (IDO) in children. We reviewed our experience and sought to ascertain the influence of dose and functional bladder capacity on outcome. PATIENTS AND METHODS: Thirty patients, aged 6-16 years, with urodynamically proven IDO, had intravesical injections of 400-500 iu of Dysport(®). Outcome was assessed clinically at least 5 months after the injection. RESULTS: Data were available for 27 patients. Urinary frequency was improved in 10; nocturia was improved in 7. Urgency resolved in 10 patients and urge incontinence in 12 (44%). Complications reported were UTI (7), urinary retention (1) and bladder pain (1). The dose of Dysport(®) used was not significantly higher (14 iu/kg v 13 iu/kg) in patients dry at follow up than in those who remained wet (p = 0.45). Functional bladder capacity was not significantly different in patients dry after treatment (p = 0.82). CONCLUSION: This retrospective study demonstrates similar response to a single treatment with intravesical Botulinum type-A toxin to previous series. We did not demonstrate a correlation between dose or functional bladder capacity and resolution of incontinence. A multi-centre study is required to further investigate this promising treatment.

Ileal bladder augmentation and vitamin B12: levels decrease with time after surgery.

OBJECTIVE: We investigated vitamin B12 deficiency following ileocystoplasty in children. METHODS: Patients who underwent ileocystoplasty between December 1993 and September 2006 were included and B12 levels were retrospectively analysed. Patients with a serum B12 of less than 150 pg/ml were considered deficient. The distance of the ileal segment from the ileocaecal valve was recorded. RESULTS: There were 105 patients in the series; 61 were male. Mean age at surgery was 7.7 years (SD = 3.9). The mean interval from surgery to most recent B12 level was 50 months (SD = 30). None of the patients were on B12 supplementation. Two patients were B12 deficient, both more than 7 years after surgery; 44% of patients with levels available 7 years after surgery had a B12 below 300 pg/ml. There was a significant negative correlation between B12 level and length of follow up (Spearman's rank, P < 0.01). Twenty patients with an ileal segment sparing 60 cm from the ileocaecal valve had a higher mean B12 (524 vs 419, SEM 60 vs 28). This was not statistically significant. CONCLUSION: We demonstrate a reduction in serum B12 level with time following ileocystoplasty. These patients should have their B12 levels measured in the long term.

The first 5-year follow up of distal antegrade continence enema stomas.

AIM: We investigated 5-year results of distal sites for antegrade continence enemas (DACE). METHODS: Patients with DACE sites placed more than 5 years previously were identified. Details of procedures were obtained. Parents, and patients over 18, were telephoned and asked to answer a standardised questionnaire. RESULTS: 31 patients were identified. Median age at DACE placement was 7 years (range 3-20). Median follow up was 92 months (range 66-145). 22 tubes were placed endoscopically, 7 were placed at open surgery and 2 at laparoscopic surgery. 28 responses to the telephone questionnaire were obtained. Of these, 15 were still using their DACE and 13 had stopped. Of those who had ceased washouts: 7 reported resolution of symptoms, 4 had a colostomy, 1 an ileostomy and 1 patient had abandoned their DACE. In patients using their stoma, washouts took a median of 5 min, with a median time to result of 25 min. 10 patients reported no soiling, 4 monthly and 1 daily soiling. Median satisfaction score was 8/10 (range 1-10/10). 24 (85%) said that they would recommend a DACE. CONCLUSIONS: This is the first report of 5-year follow up of a series of patients performing DACE washouts. The results are encouraging.

A Semicircular Incision in the Superior Umbilical Fold for SILS Preserves the Umbilical Profile.

Background. Single Incision Laparoscopic Surgery (SILS) has been highlighted in the recent literature as a means of performing a range of common, minimal access, paediatric surgical procedures. The primary attraction is the absence of visible scarring. Aim. This study aims to describe a cosmetically advantageous means of SILS port placement in children, which preserves the umbilical profile. Methods. We describe a paediatric case series utilising a semicircular incision in the superior umbilical fold for SILS procedures. The linea alba is exposed over 2 cm just superior to the umbilical ring and stay sutures are applied. A vertical incision is made over this distance without entering the umbilical ring. Data were recorded prospectively in a Microsoft Excel database. Results. Twenty-one cases were performed in a 1-year period. Ten appendicectomies, 5 ovarian/paraovarian cystectomies, 2 Palomo procedures, 3 nephrectomy/heminephrectomies, and 1 Meckel's diverticulectomy were performed. There was 1 wound infection. No incisional hernias occurred. Discussion. We believe that our technique, which maintains the integrity of the umbilical ring and allows preservation of the umbilical profile, offers a distinct cosmetic advantage over other incisions for SILS which distort it. Conclusion. We have demonstrated the aesthetic benefits of utilising a superior umbilical-fold incision for SILS in children.

European perspective on risk management and drug safety.

Risk management is an approach that has been used for many years in areas of business and government such as finance and insurance, but its use in the regulation of medicines has until recently been limited to tools such as the prescription status of a medicine (prescription-only or over-the-counter), the information provided to health-care professionals and patients, and the collection and evaluation of postmarketing safety reports.

Laparoscopic and conventional appendicectomy in children: outcomes in English hospitals between 1996 and 2006.

BACKGROUND: Laparoscopic appendicectomy is increasingly used in children. This national retrospective study compared outcomes of paediatric open and laparoscopic appendicectomy. METHODS: Length of stay, readmission rates and mortality in children undergoing open and laparoscopic appendicectomy in English NHS Trusts between 1 April 1996 and 31 March 2006 were compared. Procedures coded as emergency excision of appendix (OPCS-4 H01) on the Hospital Episode Statistics (HES) database in patients less than 15 years of age were included. Multivariate analysis was used to identify independent predictors of length of hospital stay and mortality. RESULTS: Eighty-nine thousand, four-hundred and ninety-seven (89,497) appendicectomies were studied; of which, 2,689 (3%) were performed laparoscopically. The percentage of laparoscopic cases rose from 0.6 to 8.4% between 1996 and 2006 (Pearson's r = 0.954, P < 0.001). Length of stay (median 3, interquartile range 2 days, P = 0.068) and 28-day readmission rates were similar (6.3 vs. 7.2%, respectively; P = 0.072) between groups. No independent hospital stay advantage for laparoscopy was observed (P = 0.121). No difference in 30-day mortality (P = 0.986) or 365-day mortality (P = 0.598) was demonstrated. CONCLUSION: Hospital stay, readmission rates and mortality are similar following laparoscopic and open appendicectomy in children.

Radial nerve contribution to brachialis in the UK Caucasian population: position is predictable based on surface landmarks.

The midline of the brachialis muscle is now regarded by many surgeons as an internervous plane, between the musculocutaneous nerve supply to the medial portion and a radial nerve contribution to the lateral portion, a principle applied in anterior approaches to the humerus. The radial nerve to brachialis has been described previously in East Asian specimens (Ip and Chang, 1968, Anat Rec 162:363-371; Mahakkanukrauh and Somsarp, 2002, Clin Anat 15:206-209). We sought to investigate the occurrence and character of this nerve in the UK Caucasian population. Dissection of the musculocutaneous nerve and radial nerve was carried out in Caucasian cadaveric arms (n = 42). The radial nerve was dissected from the spiral groove to the lateral epicondyle. Where a branch to brachialis was encountered, its course and level of origin relative to the length of the arm were noted. The musculocutaneous nerve innervated the brachialis in all specimens. Upon investigation 67% of specimens were found to have a radial nerve branch to brachialis. Sixty-one percent of these branches went straight into the muscle, 13% descended, and 26% recurred. The level of origin of the radial nerve branch to brachialis was at a mean of 23% of the distance between the lateral epicondyle and the acromion (n = 31, range 17-37%, SD = 5.3). In three specimens, two branches were observed. A radial nerve contribution to the innervation of the brachialis was present in 67% of UK Caucasian cadavers, which is less than that noted by others in East Asian specimens. The level of the origin of these branches is predictable based on surface landmarks. This fact may be of use during humeral surgery.