An observational study of distractions in the operating theatre.

Several studies have reported on the negative impact of interruptions and distractions on anaesthetic, surgical and team performance in the operating theatre. This study aimed to gain a deeper understanding of these events and why they remain part of everyday clinical practice. We used a mixed methods observational study design. We scored each distractor and interruption according to an established scheme during induction of anaesthesia and the surgical procedure for 58 general surgical cases requiring general anaesthesia. We made field notes of observations, small conversations and meetings. We observed 64 members of staff for 148 hours and recorded 4594 events, giving a mean (SD) event rate of 32.8 (16.3) h-1 . The most frequent events observed during induction of anaesthesia were door movements, which accounted for 869 (63%) events, giving a mean (SD) event rate of 28.1 (14.5) h-1 . These, however, had little impact. The most common events observed during surgery were case-irrelevant verbal communication and smartphone usage, which accounted for 1020 (32%) events, giving a mean (SD) event rate of 9.0 (4.2) h-1 . These occurred mostly in periods of low work-load in a sub-team. Participants ranged from experiencing these events as severe disruption through to a welcome distraction that served to keep healthcare professionals active during low work-load, as well as reinforcing the social connections between colleagues. Mostly, team members showed no awareness of the need for silence among other sub-teams and did not vocalise the need for silence to others. Case-irrelevant verbal communication and smartphone usage may serve a physical and psychological need. The extent to which healthcare professionals may feel disrupted depends on the situation and context. When a team member was disrupted, a resilient team response often lacked. Reducing disruptive social activity might be a powerful strategy to develop a habit of cross-monitoring and mutual help across surgical and anaesthetic sub-teams. Further research is needed on how to bridge cultural borders and develop resilient interprofessional behaviours.

Effect of Vagus Nerve Integrity on Short and Long-Term Efficacy of Antireflux Surgery.

OBJECTIVES: Vagus nerve injury is a feared complication of antireflux surgery (ARS) that may negatively affect reflux control. The aim of the present prospective study was to evaluate short-term and long-term impact of vagus nerve injury, evaluated by pancreatic polypeptide response to insulin-induced hypoglycemia (PP-IH), on the outcome of ARS. METHODS: In the period from 1990 until 2000, 125 patients with gastroesophageal reflux disease (GERD) underwent ARS at a single center. Before and 6 months after surgery, vagus nerve integrity testing (PP-IH), 24-h pH-monitoring, gastric emptying, and reflux-associated symptoms were evaluated. In 2014, 14-25 years after surgery, 110 patients were contacted again for evaluation of long-term symptomatic outcome using two validated questionnaires (Gastrointestinal Symptom Rating Scale (GSRS) and GERD-Health Related Quality of Life (HRQL)). RESULTS: Short-term follow-up: vagus nerve injury (PP peak ≤47 pmol/l) was observed in 23 patients (18%) 6 months after fundoplication. In both groups, a comparable decrease in reflux parameters and symptoms was observed at 6-month follow-up. Postoperative gastric emptying was significantly delayed in the vagus nerve injury group compared with the vagus nerve intact group. Long-term follow-up: patients with vagus nerve injury showed significantly less effective reflux control and a higher re-operation rate. CONCLUSIONS: Vagus nerve injury occurs in up to 20% of patients after ARS. Reflux control 6 months after surgery was not affected by vagus nerve injury. However, long-term follow-up showed a negative effect on reflux symptom control and re-operation rate in patients with vagus nerve injury.

Cost-effectiveness of same-admission versus interval cholecystectomy after mild gallstone pancreatitis in the PONCHO trial.

BACKGROUND: Same-admission cholecystectomy is indicated after gallstone pancreatitis to reduce the risk of recurrent disease or other gallstone-related complications, but its impact on overall costs is unclear. This study analysed the cost-effectiveness of same-admission versus interval cholecystectomy after mild gallstone pancreatitis. METHODS: In a multicentre RCT (Pancreatitis of biliary Origin: optimal timiNg of CHOlecystectomy; PONCHO) patients with mild gallstone pancreatitis were randomized before discharge to either cholecystectomy within 72 h (same-admission cholecystectomy) or cholecystectomy after 25-30 days (interval cholecystectomy). Healthcare use of all patients was recorded prospectively using clinical report forms. Unit costs of resources used were determined, and patients completed multiple Health and Labour Questionnaires to record pancreatitis-related absence from work. Cost-effectiveness analyses were performed from societal and healthcare perspectives, with the costs per readmission prevented as primary outcome with a time horizon of 6 months. RESULTS: All 264 trial participants were included in the present analysis, 128 randomized to same-admission cholecystectomy and 136 to interval cholecystectomy. Same-admission cholecystectomy reduced the risk of acute readmission for recurrent gallstone-related complications from 16·9 to 4·7 per cent (P = 0·002). Mean total costs from a societal perspective were €234 (95 per cent c.i. -1249 to 738) less per patient in the same-admission cholecystectomy group. Same-admission cholecystectomy was superior to interval cholecystectomy, with a societal incremental cost-effectiveness ratio of -€1918 to prevent one readmission for gallstone-related complications. CONCLUSION: In mild biliary pancreatitis, same-admission cholecystectomy was more effective and less costly than interval cholecystectomy.

Dutch Chronic Pancreatitis Registry (CARE): design and rationale of a nationwide prospective evaluation and follow-up.

BACKGROUND: Chronic pancreatitis is a complex disease with many unanswered questions regarding the natural history and therapy. Prospective longitudinal studies with long-term follow-up are warranted. METHODS: The Dutch Chronic Pancreatitis Registry (CARE) is a nationwide registry aimed at prospective evaluation and follow-up of patients with chronic pancreatitis. All patients with (suspected) chronic or recurrent pancreatitis are eligible for CARE. Patients are followed-up by yearly questionnaires and review of medical records. Study outcomes are pain, disease complications, quality of life, and pancreatic function. The target sample size was set at 500 for the first year and 1000 patients within 3 years. RESULTS: A total of 1218 patients were included from February 2010 until June 2013 by 76 participating surgeons and gastroenterologist from 33 hospitals. Participation rate was 90% of eligible patients. Eight academic centers included 761 (62%) patients, while 25 community hospitals included 457 (38%). Patient centered outcomes were assessed by yearly questionnaires, which had a response rate of 85 and 82% for year 1 and 2, respectively. The median age of patients was 58 years, 814 (67%) were male, and 38% had symptoms for less than 5 years. DISCUSSION: The CARE registry has successfully recruited over 1200 patients with chronic and recurrent pancreatitis in about 3 years. The defined inclusion criteria ensure patients are included at an early disease stage. Participation and compliance rates are high. CARE offers a unique opportunity with sufficient power to investigate many clinical questions regarding natural course, complications, and efficacy and timing of treatment strategies.

Staged multidisciplinary step-up management for necrotizing pancreatitis.

BACKGROUND: Some 15 per cent of all patients with acute pancreatitis develop necrotizing pancreatitis, with potentially significant consequences for both patients and healthcare services. METHODS: This review summarizes the latest insights into the surgical and medical management of necrotizing pancreatitis. General management strategies for the treatment of complications are discussed in relation to the stage of the disease. RESULTS: Frequent clinical evaluation of the patient's condition remains paramount in the first 24-72 h of the disease. Liberal goal-directed fluid resuscitation and early enteral nutrition should be provided. Urgent endoscopic retrograde cholangiopancreatography is indicated when cholangitis is suspected, but it is unclear whether this is appropriate in patients with predicted severe biliary pancreatitis without cholangitis. Antibiotic prophylaxis does not prevent infection of necrosis and antibiotics are not indicated as part of initial management. Bacteriologically confirmed infections should receive targeted antibiotics. With the more conservative approach to necrotizing pancreatitis currently advocated, fine-needle aspiration culture of pancreatic or extrapancreatic necrosis will less often lead to a change in management and is therefore indicated less frequently. Optimal treatment of infected necrotizing pancreatitis consists of a staged multidisciplinary 'step-up' approach. The initial step is drainage, either percutaneous or transluminal, followed by surgical or endoscopic transluminal debridement only if needed. Debridement is delayed until the acute necrotic collection has become 'walled-off'. CONCLUSION: Outcome following necrotizing pancreatitis has improved substantially in recent years as a result of a shift from early surgical debridement to a staged, minimally invasive, multidisciplinary, step-up approach.

Evaluation of long-term function, complications, quality of life and health status after restorative proctocolectomy with ileo neo rectal and with ileal pouch anal anastomosis for ulcerative colitis.

AIM: Restorative surgery after (procto)colectomy with ileo-neorectal anastomosis (INRA) or restorative proctocolectomy with ileal pouch anal anastomosis (RPC) combines cure of ulcerative colitis (UC) with restoration of intestinal continuity. This study aimed to evaluate these two operations. METHOD: Patients having INRA and RPC were matched according to sex, age at onset of UC, age at restorative surgery and duration of follow-up. Patients were included if they were over 18 years of age, had UC confirmed histopathologically and had undergone either operation. Long-term function, anal and neorectal physiology, complications, quality of life (QoL) and health status (HS) were determined. RESULTS: Seventy-one consecutive patients underwent surgery with the intention of having an INRA procedure. This was successfully carried out in 50, and 21 underwent intra-operative conversion to RPC. Median defaecation frequency was 6/24 h. In 11/71 patients reservoir failure occurred and 13/71 developed pouchitis. QoL and HS were comparable to the healthy population. Median follow-up was 6.2 years. These patients were matched with 71 patients who underwent RPC. RPC was successful in all patients. Median defaecation frequency was 8/24 h. Failure occurred in 7/71 patients and 13/71 developed pouchitis. QoL and HS were comparable with the healthy population. Median follow-up was 6.9 years. CONCLUSION: Comparison of INRA and RPC on an intention to treat basis was not considered to be realistic due to the high intra-operative conversion rate and the failures in the INRA group. RPC remains the procedure of choice for restoring intestinal continuity after proctocolectomy for UC.

Quality of life and health status before and after ileal pouch-anal anastomosis for ulcerative colitis.

BACKGROUND: Ileal pouch-anal anastomosis (IPAA) is considered the surgical treatment of choice for patients with ulcerative colitis. Quality of life (QoL) and health status are the most important patient-related outcomes. Studies investigating QoL are often cross-sectional and focus on health status. This longitudinal study evaluated QoL and health status after IPAA for ulcerative colitis and compared these with reference data from a healthy population. METHODS: Patients with ulcerative colitis who underwent a pouch operation between 2003 and 2008 completed validated questionnaires for QoL and health status. Questionnaires were completed before pouch surgery, and 6, 12, 24 and 36 months after operation. The effect of IPAA on QoL and health status was analysed, and data were compared with reference values from the healthy Dutch population. RESULTS: Data were obtained for 30 of the 32 patients. Six months after IPAA, QoL was at least comparable with that of the reference population in four of six domains. Twelve months after IPAA, overall QoL had improved, supported by findings in three QoL domains. Six months after IPAA, health status was comparable to that of the reference population in three of eight dimensions, and after 3 years it was at least comparable in five dimensions. CONCLUSION: QoL and health status increased after IPAA and reached levels comparable with those of the healthy reference population in a majority of domains and dimensions. QoL was restored first after IPAA, followed by health status.

Probiotic treatment with Probioflora in patients with predicted severe acute pancreatitis without organ failure.

BACKGROUND: We previously demonstrated that probiotic prophylaxis, in patients with predicted severe pancreatitis, did not prevent infectious complications but unexpectedly increased the risk of bowel ischemia and mortality. The suggestion that these negative findings are only observed in the presence of organ failure at the start of probiotic treatment has not been confirmed. METHODS: In a retrospective analysis, all patients with predicted severe acute pancreatitis without initial organ failure admitted to a medium care facility of a teaching hospital in Prague from January 2003 to December 2010 were included. All patients routinely received probiotic treatment with Probioflora. Total parenteral nutrition (TPN) was routinely started and shifted toward total enteral nutrition. Infectious complications, mortality and the incidence of bowel ischemia were recorded. RESULTS: 99 consecutive patients, mean age 56 years, were included. Infectious complications occurred in 42 patients (42%), consisting of bacteremia (n = 40), pneumonia (n = 11) and infected necrosis (n = 11). Bowel ischemia was detected in two patients (2%). Overall mortality was 8%. CONCLUSION: In this retrospective study no apparent positive or negative impact of probiotic treatment with Probioflora was demonstrated when administered to patients with predicted severe acute pancreatitis without initial organ failure.

The ileo neo-rectal anastomosis in patients with familial adenomatous polyposis: a prospective case series with long-term follow up.

AIM: In patients with familial adenomatous polyposis (FAP), removal of the colonic mucosa is essential to reduce the lifetime risk of developing cancer). For this purpose, ileo-pouch anal anastomosis (IPAA) has been the gold standard, but morbidity related to the dissection of the pelvis remains substantial. In an attempt to reduce the procedure-related complications of pelvic dissection, ileoneo-rectal anastomosis (INRA) has been developed. In this case series of FAP patients, the long-term functional results, morbidity and quality of life (QoL) of the INRA procedure were evaluated and compared with its early outcome. METHOD: Long-term follow up of a consecutive group of eight FAP patients with an INRA procedure (between 1998 and 2005) was undertaken. Data on functional results, complications, manometry and endoscopy were recorded prospectively. RESULTS: Eight patients with FAP underwent the INRA procedure. The median number of defaecations over 24 h was five. No pelvic sepsis or bladder dysfunction occurred. One patient, in whom concomitant Crohn's disease was diagnosed in retrospect, was converted to IPAA. In the INRA patients, no sexual dysfunction occurred. Endoscopic examination showed normal mucosa without any evidence of polyp formation. CONCLUSION: Restorative surgery by means of the INRA procedure yields good functional results in FAP patients, without any pelvic dissection-related morbidity or regrowth of polyps in the neo-rectum.

Effects of anti-reflux surgery on weakly acidic reflux and belching.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) is the most frequently performed operation for gastro-oesophageal reflux disease (GORD). However, 12% of the patients have persistent reflux symptoms and 19% develop gas-related symptoms after LNF. Weakly acidic reflux and inability to belch have been alleged to cause these symptoms, respectively. The effect of LNF on weakly acidic reflux and (supra) gastric belching was evaluated. METHODS: In 31 patients upper gastrointestinal endoscopy, stationary oesophageal manometry and 24-h impedance-pH monitoring off acid secretion inhibiting drugs was performed before and 6 months after primary LNF for GORD that was refractory to proton pump inhibitors. Patients filled out validated questionnaires on GERD-HRQoL before and 3, 6 and 12 months after surgery. RESULTS: LNF reduced reflux symptoms (18.6→1.6; p = 0.015). The procedure drastically reduced the incidence (number per 24 h) of acid (76.0→1.6; p < 0.001) and weakly acidic (13.6→5.7; p = 0.001) as well as liquid (53.4→5.4; p<0.001) and mixed reflux episodes (36.3→1.9; p < 0.001). In contrast, gas reflux was reduced to lesser extent (35.6→25.7; p = 0.022). Proximal, mid-oesophageal and distal reflux were reduced to a similar extent. Persistent GORD symptoms were neither preceded by acid nor by weakly acidic reflux. The number of air swallows did not change, but the number of gastric belches (GBs) was greatly reduced (68.5→23.9; p < 0.001). Twenty-three patients had supragastric belches (SGBs), both before and after surgery, whereas eight patients had no SGBs at all. The majority of SGBs were not reflux associated and the frequency was greatly increased after LNF (20.8→46.0; p = 0.036). Reflux-associated SGBs were abolished after surgery (14.0→0.4; p < 0.001). CONCLUSIONS: LNF similarly controls acid and weakly acidic reflux, but gas reflux is reduced to lesser extent. Persistent reflux symptoms are neither caused by acid nor by weakly acidic reflux. LNF alters the belching pattern by reducing GBs (air venting from stomach) and increasing SGBs (no air venting from stomach). This explains the increase in belching experienced by some patients after LNF, despite the reduction in gastric belching. It can be hypothesised that the reduction in GBs after LNF incites patients to increase SGBs in a futile attempt to vent air from the stomach.

Impact of symptom-reflux association analysis on long-term outcome after Nissen fundoplication.

BACKGROUND: A positive symptom association probability (SAP) is regarded as an important selection criterion for antireflux surgery by many physicians. However, no data corroborate the relationship between symptom-reflux association and outcome, nor is it clear what impact a negative SAP has on the outcome of antireflux surgery in patients with abnormal oesophageal acid exposure. This study compared long-term outcomes of Nissen fundoplication in patients with a negative versus positive SAP. METHODS: Five-year outcome of Nissen fundoplication in patients with proton-pump inhibitor (PPI)-refractory reflux and pathological acid exposure was compared between those with (SAP+, 109) and without (SAP-, 29 patients) a positive symptom association. Symptoms, quality of life (QoL), PPI use, endoscopic findings, manometry and acid exposure were evaluated. RESULTS: At 5 years' follow-up, relief of reflux symptoms (95 versus 87 per cent), reduction in PPI use (80 to 25 per cent versus 85 to 14 per cent; P < 0·050) and improvement in QoL were similar in the SAP- and SAP+ groups. Reduction in acid exposure time (13·4 to 1·6 per cent versus 11·1 to 0·2 per cent of total time; P < 0·010), improvement in oesophagitis (44 to 6 per cent versus 61 to 13 per cent; P < 0·050) and increase in lower oesophageal sphincter pressure were also comparable. CONCLUSION: The subjective and objective outcomes of fundoplication in patients with pathological acid exposure are comparable among those with a positive and negative SAP. Patients with pathological acid exposure and a negative SAP can also benefit from antireflux surgery.

Timing of cholecystectomy after mild biliary pancreatitis.

BACKGROUND: The aim of the study was to evaluate recurrent biliary events as a consequence of delay in cholecystectomy following mild biliary pancreatitis. METHODS: Between 2004 and 2007, patients with acute pancreatitis were registered prospectively in 15 Dutch hospitals. Patients with mild biliary pancreatitis were candidates for cholecystectomy. Recurrent biliary events requiring admission before and after cholecystectomy, and after endoscopic sphincterotomy (ES), were evaluated. RESULTS: Of 308 patients with mild biliary pancreatitis, 267 were candidates for cholecystectomy. Eighteen patients underwent cholecystectomy during the initial admission, leaving 249 potential candidates for cholecystectomy after discharge. Cholecystectomy was performed after a median of 6 weeks in 188 patients (75·5 per cent). Before cholecystectomy, 34 patients (13·7 per cent) were readmitted for biliary events, including 24 with recurrent biliary pancreatitis. ES was performed in 108 patients during the initial admission. Eight (7·4 per cent) of these patients suffered from biliary events after ES and before cholecystectomy, compared with 26 (18·4 per cent) of 141 patients who did not have ES (risk ratio 0·51, 95 per cent confidence interval 0·27 to 0·94; P = 0·015). Following cholecystectomy, eight (3·9 per cent) of 206 patients developed biliary events after a median of 31 weeks. Only 142 (53·2 per cent) of 267 patients were treated in accordance with the Dutch guideline, which recommends cholecystectomy or ES during the index admission or within 3 weeks thereafter. CONCLUSION: A delay in cholecystectomy after mild biliary pancreatitis carries a substantial risk of recurrent biliary events. ES reduces the risk of recurrent pancreatitis but not of other biliary events.

Systematic review of percutaneous catheter drainage as primary treatment for necrotizing pancreatitis.

BACKGROUND: The role of percutaneous catheter drainage (PCD) in patients with (infected) necrotizing pancreatitis was evaluated. METHODS: A systematic literature search was performed. Inclusion criteria were: consecutive cohort of patients with necrotizing pancreatitis undergoing PCD as primary treatment for peripancreatic collections; indication for PCD either (suspected) infected necrosis or symptomatic sterile pancreatic necrosis; and outcomes reported to include percentage of infected peripancreatic collections, need for additional surgical necrosectomy, complications and deaths. Exclusion criteria were: cohort of fewer than five patients; cohort included patients with chronic pancreatitis; selected subgroup of patients with acute pancreatitis studied, such as those with pseudocysts, pancreatic abscesses and/or exclusively sterile pancreatic necrosis; and cohort in which PCD was combined with another minimally invasive strategy and results for PCD alone not reported separately. RESULTS: Eleven studies, including 384 patients, fulfilled the inclusion criteria. Only one study was a randomized controlled trial; most others were retrospective case series. Four studies reported on the presence of organ failure before PCD; this occurred in 67·2 per cent of 116 patients. Infected necrosis was proven in 271 (70·6 per cent) of 384 patients. No additional surgical necrosectomy was required after PCD in 214 (55·7 per cent) of 384 patients. Complications consisted mostly of internal and external pancreatic fistulas. The overall mortality rate was 17·4 per cent (67 of 384 patients). Nine of 11 studies reported mortality separately for patients with infected necrosis undergoing PCD; the mortality rate in this group was 15·4 per cent (27 of 175). CONCLUSION: A considerable number of patients can be treated with PCD without the need for surgical necrosectomy.

Prediction of common bile duct stones in the earliest stages of acute biliary pancreatitis.

BACKGROUND AND STUDY AIMS: Accurate prediction of common bile duct (CBD) stones in acute biliary pancreatitis is warranted to select patients for early therapeutic endoscopic retrograde cholangiopancreatography (ERCP). We evaluated commonly used biochemical and radiological predictors of CBD stones in a large prospective cohort of patients with acute biliary pancreatitis who were undergoing early ERCP. PATIENTS AND METHODS: 167 patients with acute biliary pancreatitis who were undergoing early ERCP (< 72 hours after symptom onset) in 15 Dutch hospitals in 2004 - 2007 were prospectively included. Abdominal ultrasonography and/or computed tomography (CT) was performed on admission and complete liver biochemistry determined daily. We used univariate logistic regression to assess associations between CBD stones found during ERCP (gold standard) and the following parameters: (1) clinical: age, sex, predicted severity; (2) radiological: dilated CBD, impacted stone in CBD; and (3) biochemical: bilirubin, γ-glutamyltransferase (GGT), alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST). RESULTS: Out of 167 patients, 94 (56 %) had predicted severe acute biliary pancreatitis, 51 (31%) exhibited a dilated CBD and 15 (9%) had CBD stones on ultrasonography and/or CT. ERCP was performed at a median of 0 days (interquartile range 0 - 1) after admission. CBD stones were found during ERCP in 89/167 patients (53%). In univariate analysis, the only parameters significantly associated with CBD stones were GGT (per 10 units increase: odds ratio 1.02, 95% CI 1.01 - 1.03, P = 0.001) and alkaline phosphatase (per 10 units increase: odds ratio 1.03, 95% CI 1.00 - 1.05, P = 0.028). These and all other tested parameters, however, showed poor positive predictive value (ranging from 0.53 to 0.69) and poor negative predictive value (ranging from 0.46 to 0.67). CONCLUSIONS: The results of this study suggest that commonly used biochemical and radiological predictors of the presence of CBD stones during ERCP in the earliest stages of acute biliary pancreatitis are unreliable.

Long-term quality of life after surgery for chronic pancreatitis.

BACKGROUND: Surgery for chronic pancreatitis is indicated for intractable pain or the treatment of complications. This retrospective cohort study evaluated the applicability of pain coping and quality-of-life (QOL) scoring in patients with chronic pancreatitis. METHODS: Between 1995 and 2008, 155 patients underwent surgery for chronic pancreatitis in two Dutch university hospitals. Medical charts were reviewed, and QOL and coping with pain were assessed by two validated questionnaires. RESULTS: Median follow-up was 5.6 years. The aetiology was alcohol related in 48.3 per cent. Some 111 resections and 46 drainage procedures were performed. Fifty-seven patients had major complications and the hospital mortality rate was 1.3 per cent. After surgery the number of patients needing analgesics was reduced (P < 0.001). Alcohol consumption significantly reduced pain coping mechanisms (P = 0.032). Overall, QOL remained poor after surgery. Scores on three dimensions of the QOL questionnaire were significantly better after drainage than after resection procedures. CONCLUSION: In general, QOL after surgery for chronic pancreatitis remains poor, owing to pre-existing lifestyle and co-morbidity. Patients selected for a pancreatic duct drainage procedure have a better postoperative QOL than those undergoing resectional procedures. Alcohol consumption is associated with poor ability to cope with pain after surgery and should be discouraged.

Long-term outcome of Nissen fundoplication in non-erosive and erosive gastro-oesophageal reflux disease.

BACKGROUND: Non-erosive (NERD) and erosive (ERD) gastro-oesophageal reflux disease (GORD) show similar severity of symptoms and impact on quality of life (QoL). Prospective data on long-term outcomes of antireflux surgery in NERD are lacking. METHODS: Subjective and objective 5-year outcomes of Nissen fundoplication were compared in 96 patients with NERD and 117 with ERD, operated on for proton-pump inhibitor (PPI)-refractory GORD. RESULTS: Preoperative and postoperative QoL, PPI use, acid exposure time, symptom-reflux correlation, lower oesophageal sphincter (LOS) pressure and reoperation rates were similar in the two groups. At 5 years, relief of reflux symptoms was similar (NERD 89 per cent versus ERD 96 per cent), PPI use showed a similar reduction (82 to 21 per cent versus 81 to 15 per cent respectively; both P < 0.001) and QoL score improved equally (50.3 to 65.2 (P < 0.001) versus 52.0 to 60.7 (P = 0.016)). Five patients with NERD developed erosions after surgery; oesophagitis healed in 87 per cent of patients with ERD. Reduction in total acid exposure time (NERD 12.7 to 2.0 per cent versus ERD 13.8 to 2.9 per cent; both P < 0.001) and increase in LOS pressure (1.3 to 1.8 kPa versus 1.2 to 1.8 kPa; both P < 0.001) were similar. The reintervention rate was comparable (NERD 15 per cent versus ERD 12.8 per cent). CONCLUSION: Patients with PPI-refractory NERD and ERD benefit equally from Nissen fundoplication. The absence of mucosal lesions on endoscopy in patients with proven PPI-refractory reflux disease is not a reason to refrain from antireflux surgery.

Systematic review and meta-analysis of laparoscopic Nissen (posterior total) versus Toupet (posterior partial) fundoplication for gastro-oesophageal reflux disease.

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) is currently considered the surgical approach of choice for gastro-oesophageal reflux disease (GORD). Laparoscopic Toupet fundoplication (LTF) has been said to reduce troublesome dysphagia and gas-related symptoms. A systematic review and meta-analysis of randomized clinical trials (RCTs) was performed to compare LNF and LTF. METHODS: Four electronic databases (MEDLINE, Embase, Cochrane Library and ISI Web of Knowledge CPCI-S) were searched and the methodological quality of included trials was evaluated. Outcomes included recurrent pathological acid exposure, oesophagitis, dysphagia, dilatation for dysphagia and reoperation rate. Results were pooled in meta-analyses as risk ratios (RRs) and weighted mean differences. RESULTS: Seven eligible RCTs comparing LNF (n = 404) with LTF (n = 388) were identified. LNF was associated with a significantly higher prevalence of postoperative dysphagia (RR 1.61 (95 per cent confidence interval 1.06 to 2.44); P = 0.02) and dilatation for dysphagia (RR 2.45 (1.06 to 5.68); P = 0.04). There were more surgical reinterventions after LNF (RR 2.19 (1.09 to 4.40); P = 0.03), but no differences regarding recurrent pathological acid exposure (RR 1.26 (0.82 to 1.95); P = 0.29), oesophagitis (RR 1.20 (0.78 to 1.85); P = 0.40), subjective reflux recurrence, patient satisfaction, operating time or in-hospital complications. Inability to belch (RR 2.04 (1.19 to 3.49); P = 0.009) and gas bloating (RR 1.58 (1.21 to 2.05); P < 0.001) were more prevalent after LNF. CONCLUSION: LTF reduces postoperative dysphagia and dilatation for dysphagia compared with LNF. Reoperation rate and prevalence of gas-related symptoms were lower after LTF, with similar reflux control. These results provide level 1a support for the use of LTF as the posterior fundoplication of choice for GORD.

Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials.

OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical methods are identified for meta-analysis with zero-event trials, leading to numerous data analyses. We used the binary outcomes from our Cochrane review of randomized trials of laparoscopic vs. small-incision cholecystectomy for patients with symptomatic cholecystolithiasis to illustrate the influence of statistical method on inference. RESULTS: In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes. CONCLUSIONS: The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event trials.

Oesophageal acid hypersensitivity is not a contraindication to Nissen fundoplication.

BACKGROUND: The Rome III criteria classify patients with a positive relationship between symptoms and reflux episodes but a physiological oesophageal acid exposure time as having gastro-oesophageal reflux disease (GORD) with an acid hypersensitive oesophagus. The long-term outcome of antireflux surgery in these patients was investigated. METHODS: Outcomes of Nissen fundoplication in 28 patients with GORD refractory to proton-pump inhibitors (PPIs) and oesophageal acid hypersensitivity (group 1) were compared with those of 126 patients with pathological acid exposure (group 2). RESULTS: Fundoplication had a similar effect in both groups. Three months after surgery, total acid exposure time and the prevalence of oesophagitis had decreased, whereas mean lower oesophageal pressure had increased. The percentage of patients using PPIs was reduced from 83 to 4 per cent in group 1 and from 86.1 to 7.4 per cent in group 2 (both P < 0.001). Quality of life measured on a scale from 0 to 100 improved from 52 to 69 (P = 0.009) and 64 (P < 0.001) respectively. The percentage of patients with resolved or improved symptoms at 5 years was similar. CONCLUSION: Patients with oesophageal acid hypersensitivity benefit from Nissen fundoplication as much as those with pathological acid exposure.

Timing and impact of infections in acute pancreatitis.

BACKGROUND: Although infected necrosis is an established cause of death in acute pancreatitis, the impact of bacteraemia and pneumonia is less certain. METHODS: This was a cohort study of 731 patients with a primary episode of acute pancreatitis in 2004-2007, including 296 patients involved in a randomized controlled trial to investigate the value of probiotic treatment in severe pancreatitis. Time of onset of bacteraemia, pneumonia, infected pancreatic necrosis, persistent organ failure and death were recorded. RESULTS: The initial infection in 173 patients was diagnosed a median of 8 (interquartile range 3-20) days after admission (infected necrosis, median day 26; bacteraemia/pneumonia, median day 7). Eighty per cent of 61 patients who died had an infection. In 154 patients with pancreatic parenchymal necrosis, bacteraemia was associated with increased risk of infected necrosis (65 versus 37.9 per cent; P = 0.002). In 98 patients with infected necrosis, bacteraemia was associated with higher mortality (40 versus 16 per cent; P = 0.014). In multivariable analysis, persistent organ failure (odds ratio (OR) 18.0), bacteraemia (OR 3.4) and age (OR 1.1) were associated with death. CONCLUSION: Infections occur early in acute pancreatitis, and have a significant impact on mortality, especially bacteraemia. Prophylactic strategies should focus on early intervention.