Adherence to General Medical Council guidance regarding disclosure of alternative treatments during the consent process.

INTRODUCTION: General Medical Council (GMC) guidelines dictate that reasonable alternatives to treatment should be disclosed during the consent process. We aimed to determine whether GMC guidelines on disclosure of alternatives during consent are being followed in a real-world example which is disclosure of non-operative management as an alternative to appendicectomy in uncomplicated paediatric appendicitis. METHODS: We undertook a retrospective single-centre observational study and national consultant specialist paediatric surgeon survey. Two groups of 50 consecutively treated children (<16 years) with acute uncomplicated appendicitis were included in the observational study during two periods. UK-based consultant surgeons who treat appendicitis were included in the national survey. The main outcomes were disclosure and use of non-operative management (NOM) as an alternative to appendicectomy. RESULTS: Overall, in the observational study, NOM was disclosed in 30 (30%) children and 77% (23/30) opted for this treatment method when it was disclosed. There were 83 survey respondents representing all 25 eligible specialist paediatric surgery centres. Ten (12%) consultants reported routinely offering NOM, 39 (47%) offer it in select circumstances, and 34 (41%) never offer NOM. Only 25 (30%) respondents always disclose NOM as an alternative to appendicectomy, whereas 22 (27%) never do. Consultants who never disclose NOM are more likely to prefer appendicectomy over NOM compared with those who always disclose it (p<0.001). CONCLUSION: In this illustrative clinical scenario, observed and reported practice regarding disclosure of alternative treatments during the consent process do not meet GMC guidance. This risks depriving children and caregivers of a choice that they are entitled to.

Type II Cryoglobulinaemia causing Monoclonal Gammopathy of Renal Significance.

A 53 year old female with a background of hypertension, hypothyroidism and Raynaud's was admitted with an acute ischaemic stroke and referred to the renal team after a routine urine dip revealed microscopic haematuria and nephrotic-range proteinuria. Blood tests revealed renal impairment, a monoclonal IgM kappa paraprotein, low complement C4 concentration and a positive rheumatoid factor. Active cryoglobulinaemia was suspected and testing demonstrated type II cryoglobulins secondary to the monoclonal IgM kappa paraprotein. Bone marrow biopsy was normal. Renal biopsy revealed cryoglobulinaemia associated membranoproliferative glomerulonephritis. Treatment with steroids and rituximab improved renal function and proteinuria. This case fits within the evolving spectrum of disorders now termed Monoclonal Gammopathy of Renal Significance and highlights the value of biopsying and treating these patients early.

Basal body multipotency and axonemal remodelling are two pathways to a 9+0 flagellum.

Eukaryotic cilia/flagella exhibit two characteristic ultrastructures reflecting two main functions; a 9+2 axoneme for motility and a 9+0 axoneme for sensation and signalling. Whether, and if so how, they interconvert is unclear. Here we analyse flagellum length, structure and molecular composition changes in the unicellular eukaryotic parasite Leishmania during the transformation of a life cycle stage with a 9+2 axoneme (the promastigote) to one with a 9+0 axoneme (the amastigote). We show 9+0 axonemes can be generated by two pathways: by de novo formation and by restructuring of existing 9+2 axonemes associated with decreased intraflagellar transport. Furthermore, pro-basal bodies formed under conditions conducive for 9+2 axoneme formation can form a 9+0 axoneme de novo. We conclude that pro-centrioles/pro-basal bodies are multipotent and not committed to form either a 9+2 or 9+0 axoneme. In an alternative pathway structures can also be removed from existing 9+2 axonemes to convert them to 9+0.

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.

Candour for surgeons: the absence of spin.

Doctors are exhorted to be candid with their patients when clinical errors occur. This paper discusses the history of candour in surgical law as well as recommendations resulting from the Mid Staffordshire public inquiry. It also looks at why candour is necessary and where the threshold should lie. Provided surgeons understand that a duty of candour is engaged at a certain threshold of harm, then disclosure of misadventure to patients or their relatives becomes simply a matter for clinical judgement, just in the same way as a surgeon judges which potential operative complications need to be disclosed during the consenting process.

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.

Scope and feasibility of operating on the neonatal intensive care unit: 312 cases in 10 years.

PURPOSE: To report the scope, feasibility and learning experience of operating on neonates on the neonatal intensive care unit (NICU). METHODS: (1) Review of all NICU operations performed by general neonatal surgeons over 10 years; (2) 6-month prospective comparison of procedures performed in NICU or operating room; (3) structured interviews with five surgeons with 1-13 years experience of operating on NICU. RESULTS: 312 operations were performed in 249 infants. Median birth weight was 1,494 g (range 415-4,365), gestational age 29 weeks (22-42), and age at operation 25 days (0-163). Nearly half (147) were laparotomy for acute abdominal pathology in preterm, very low birth-weight infants There were no surgical adverse events related to location of surgery. Surgeon satisfaction with operating on NICU for this population was high (5/5). Several factors contribute to making this process a success. CONCLUSIONS: This is the largest reported series of general neonatal surgical procedures performed on NICU. Operating on NICU is feasible and safe, and a full range of neonatal operations can be performed. It removes risks associated with neonatal transfer and is likely to reduce physiological instability. We recommend this approach for all ventilated neonates and urge neonatal surgeons to operate at the cotside of unstable infants.

Checking pregnancy status in adolescent girls before procedures under general anaesthesia.

OBJECTIVE: Surgery, ionising radiation and anaesthesia in the presence of an undetected pregnancy could be harmful. British guidelines state that female patients of 'childbearing age' should have their pregnancy status established before surgery. Approaching this topic with an adolescent girl can be challenging. DESIGN: The authors conducted an observational study and a survey in their institution and a national survey of Association of Paediatric Anaesthetists (APA) linkmen. SETTING: Local: Southampton. National: UK. RESULTS: Both surveys demonstrate widespread concerns about inconsistent and informal practices. Only 45% of respondents in the authors' institution stated they ask adolescent girls if they could be pregnant. 40% of APA linkmen were unaware of national guidelines. CONCLUSIONS: This work illustrates the need for consistent national guidance. We propose that all girls who have reached menarche should be routinely offered a urine pregnancy test before any procedure under general anaesthesia.

The numeric threshold for the disclosure of risk: outdated and inapplicable to surgical consent.

When describing the risks of surgery to a patient, there is a common and mistaken supposition by surgeons that there exists a numeric threshold of improbability beyond which there is no need to disclose. Where should the line be drawn?

A new intraperitoneal technique for safe repair of incarcerated inguinal hernias: a novel technique to consider.

INTRODUCTION: Inguinal herniotomy is one of the most common operations performed by paediatric surgeons. Most procedures are elective operations but occasionally the hernia is incarcerated. Complications after emergency repair of an incarcerated hernia repair are higher than those associated with elective surgery because of congestion of the sac. Operative techniques described so far include low, high, preperitoneal and laparoscopic approaches. We describe here an open intraperitoneal technique. METHODS: 6 boys aged between 4-40 weeks were taken urgently to the operating room for incarcerated inguinal hernia repair. All boys were operated on using an open intraperitoneal technique. In this technique, the congested sac does not need to be separated from the adherent vas and vessels within the inguinal canal, the reduced bowel can be inspected with 3D visualisation and resected if necessary, and the peritoneum can be easily incised and sutured through a single skin incision, reducing the risk of complications and providing superior cosmesis. RESULTS: All patients had very good postoperative outcomes with no complications. CONCLUSIONS: The technique can be used not only for incarcerated inguinal hernia repair but also for problematic repairs of recurrent hernias. Disadvantages include postoperative hydrocele formation and failure to inspect the testicle.

Trans-anastomotic tubes reduce the need for central venous access and parenteral nutrition in infants with congenital duodenal obstruction.

PURPOSE: To determine the effect of trans-anastomotic tube (TAT) feeding on outcome following repair of congenital duodenal obstruction (CDO). METHODS: Retrospective comparative study of all infants with CDO over 10 years. Data are median (range). Mann-Whitney U test and Fisher's exact test were used. RESULTS: Of 55 infants with CDO (48 atresia, 7 stenosis), 17 were managed with a TAT, 38 without. Enteral feeds were commenced earlier in infants with a TAT compared to those without (TAT 2 days post-repair [1-4] vs. no-TAT 3 days post-repair [1-7]; p = 0.006). Infants with a TAT achieved full enteral feeds significantly sooner than those without (TAT 6 days post-repair [2-12] vs. no-TAT 9 days post-repair [3-36]; p = 0.005). Significantly fewer infants in the TAT group required central venous catheter (CVC) placement and parenteral nutrition (PN) than in the no-TAT group (TAT 2/17 vs. no-TAT 28/38, p < 0.0001). There were six CVC-related complications (5 infections, 1 PN extravasation) and four TATs became displaced and were removed before achieving full enteral feeds. One infant with a TAT with trisomy 21 and undiagnosed Hirschsprung disease developed an anastomotic leak and jejunal perforation requiring re-operation. CONCLUSIONS: A TAT significantly shortens time to full enteral feeds in infants with CDO significantly reducing the need for central venous access and PN.

A case study of mixed cryoglobulinaemia associated with peripheral neuropathy.

The clinical diagnosis of mixed cryoglobulinaemia is difficult due to heterogeneity in presentation. Symptoms include the classical triad of purpura, arthralgia and weakness, with one or more other organs involved. We discuss a case of cryoglobulinaemia that presented with sensory motor neuropathy and with features of mononeuritis multiplex syndrome, but which lacked other classical features. Laboratory testing revealed a profile typical of mixed cryoglobulins: immunoglobulin M (IgM) paraprotein, low fourth carbon (C4) and positive rheumatoid factor. Subsequent investigations failed to reveal an underlying infectious or neoplastic cause. This case demonstrates the need to include cryoglobulinaemia in the differential diagnosis for peripheral neuropathy, and the critical importance of using the correct collection procedure to isolate cryoglobulins.

Consent: luck or law?

INTRODUCTION: The aim of this study was to identify whether clinicians are obtaining a valid consent for surgery, and ascertain the parents' perception of parental responsibility when giving consent for their children. PATIENTS AND METHODS: Adults consenting for 100 children were questioned about the possession of parental responsibility, and their understanding of the concept. RESULTS: Only 4 children had surgery without valid consent, these forms being signed by fathers without parental responsibility. However, only 5% of the sample stated that parental responsibility was required. More than 80% believed that cohabitation was a sufficient qualification to provide consent; fewer than 15% recognising any influence of marital status. It seems that, although 96% of consenters had parental responsibility, the validity of their consent was a product more of luck than of lawful behaviour. CONCLUSIONS: The results demonstrate a wide gulf between the standards set by the Children Act 1989 and common practice, as perceived by parents. Furthermore, this reveals a significant disparity between the principles behind the statute, and the role that parents believe that they play in the 21st century.

The use of deslorelin implants for the synchronization of estrous in diestrous bitches.

A novel approach to estrous induction in diestrous bitches is described. Twelve spontaneously cycling anestrous bitches served as controls. Thirteen anestrous and 15 diestrous bitches were induced to come into synchronous estrous using prostaglandin (diestrous bitches only) and deslorelin implants (Ovuplant). Implants contained either 2.1 or 1.05 mg deslorelin and were administered beneath the vestibular submucosa. All treated bitches came into estrous, regardless of implant size. Whereas all anestrous bitches ovulated, one of six diestrous bitches treated with the larger implant and three of nine treated with the smaller implant failed to ovulate. Induced bitches generally produced fewer corpora lutea than controls. Sixty-seven percent of control bitches became pregnant, with 0.63 fetuses per corpus luteum, whereas the pregnancy rate and fetuses per corpus luteum were 67 and 70% and 0.42 and 0.55 in the anestrous bitches induced with 1.05 and 2.1 mg deslorelin implants, respectively (not different from controls). Only 2 of 15 induced diestrous bitches conceived a detectable pregnancy, one of which was resorbed. In conclusion, although ovulatory estrous can be induced in bitches that had their most recent ovulation 40-100 days ago, these bitches are very unlikely to become pregnant during the induced estrous. The reason for the poor fertility in these diestrous bitches requires further study.

Failure of hCG to support luteal function in bitches after estrus induction using deslorelin implants.

Induction of estrus with deslorelin implants was followed by abortions in bitches that conceived during the induced estrus. Lowering the deslorelin dose and choosing a better implantation site prevented the abortions. This study investigated the hypothesis that induction of estrus with deslorelin is followed by reduced serum progesterone concentrations (SPC) during the ensuing diestrus. Assuming that reduced luteal function resulted from reduced LH secretion due to hypophyseal down-regulation of GnRH receptors, the effect of human chorionic gonadotropin (hCG) treatment on the SPC of diestrous bitches was also investigated. In Experiment 1, 10 spontaneously cycling bitches served as controls, whereas estrus was induced with deslorelin implants in 24 others. In Experiment 2, six diestrous bitches were treated with a single dose of hCG between Days 39 and 45 of diestrus. The SPC was lower in deslorelin-induced bitches from Days 35 to 56 of diestrus and hCG increased SPC during the first 24 h after treatment, followed by a dramatic decline thereafter. Although SPC recovered in pregnant bitches, it remained much lower (< or = 1 ng/mL) than in untreated, non-pregnant bitches. The suppression of progesterone secretion after hCG treatment suggested that decreased luteal activity in deslorelin-induced bitches may not be a simple consequence of down-regulation of hypophyseal GnRH receptors.

RTOG 96-10: reirradiation with concurrent hydroxyurea and 5-fluorouracil in patients with squamous cell cancer of the head and neck.

PURPOSE: Patients with recurrent squamous cell cancer of the head and neck (SCH&N) are generally treated with systemic chemotherapy. Improvement in survival has not occurred, despite an increased objective response rate. This study was undertaken to explore the feasibility and toxicity, and estimate the therapeutic impact of, reirradiation (RRT) with concurrent hydroxyurea and 5-fluorouracil. METHODS AND MATERIALS: The eligibility requirements included SCH&N presenting as a second primary or recurrence > or =6 months after definitive RT to > or =45 Gy, with > or =75% of the tumor volume within the previous field. The cumulative spinal cord dose was limited to 50 Gy, and measurable disease was required. Four weekly cycles were given, each separated by 1 week of rest. A cycle consisted of 5 days, Monday through Friday, of 1.5-Gy twice-daily repeated RT, with the fractions separated by > or =6 h, with 1.5 g of hydroxyurea given 2 h and 300 mg/m2 of a 5-fluorouracil IV bolus given 30 min before each second daily fraction. RESULTS: Eighty-six patients were entered; 81 patients were assessable. The median prior radiation dose was 61.2 Gy. The 4 planned cycles were delivered in 79% of patients. Grade 3 mucositis occurred in 14% of patients, and Grade 4 in 5%. Grade 3 acute pharyngeal toxicity was seen in 17%. Grade 3 neutropenia occurred in 9%, Grade 4 in 10%, and Grade 5 in 7%. Six patients died of treatment-related toxicity. Two died of hemorrhage from the tumor site without thrombocytopenia. With a median follow-up of 16.3 months for living patients, the estimated median overall survival was 8.2 months and the estimated 1-year survival rate 41.7%. Patients treated >3 years after the previous RT had a 1-year survival rate of 48% compared with 35% for patients treated within 3 years (p = 0.017). The 1-year survival rate for patients with a second primary was 54% compared with 38% for patients with recurrence (p = 0.083). CONCLUSION: Repeated RT with concurrent chemotherapy as given in this study is a feasible approach for selected, previously irradiated patients with SCH&N and may produce increased median and 1-year survival rates compared with systemic chemotherapy trials reported in the literature. A randomized study should be conducted to compare these two different approaches.

Diversion procto-colitis: response to treatment with short-chain fatty acids.

BACKGROUND/PURPOSE: Diversion procto-colitis (DPC) results from a deficiency of luminal short-chain fatty acids (SCFAs). Endoscopic and histopathologic features of the disorder are almost universally present in defunctioned bowel, but symptomatic DPC is less common. METHODS: Five children with symptomatic DPC underwent endoscopy and rectosigmoid biopsies. An endoscopic index (EI) was used to quantify disease severity. An SCFA mixture was administered into the defunctioned bowel. RESULTS: A good clinical response and improvement in the endoscopic index occurred in all children. Undiversion or rectal excision was carried out in 4 and was curative in each case. One child is awaiting a redo pull through. CONCLUSIONS: DPC should be considered in children with a defunctioned colon presenting with evidence of colitis. Histopathology provides supportive evidence and SCFAs may provide effective relief of symptoms. Stoma reversal or rectal excision is curative.