Michael J. Johnston

Crohn's disease management after intestinal resection: a randomised trial.

BACKGROUND Most patients with Crohns disease need an intestinal resection, but a majority will subsequently experience disease recurrence and require further surgery. This study aimed to identify the optimal strategy to prevent postoperative disease recurrence. METHODS In this randomised trial, consecutive patients from 17 centres in Australia and New Zealand undergoing intestinal resection of all macroscopic Crohns disease, with an endoscopically accessible anastomosis, received 3 months of metronidazole therapy. Patients at high risk of recurrence also received a thiopurine, or adalimumab if they were intolerant to thiopurines. Patients were randomly assigned to parallel groups: colonoscopy at 6 months (active care) or no colonoscopy (standard care). We used computer-generated block randomisation to allocate patients in each centre to active or standard care in a 2:1 ratio. For endoscopic recurrence (Rutgeerts score ≥i2) at 6 months, patients stepped-up to thiopurine, fortnightly adalimumab with thiopurine, or weekly adalimumab. The primary endpoint was endoscopic recurrence at 18 months. Patients and treating physicians were aware of the patients study group and treatment, but central reading of the endoscopic findings was undertaken blind to the study group and treatment. Analysis included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT00989560. FINDINGS Between Oct 13, 2009, and Sept 28, 2011, 174 (83% high risk across both active and standard care groups) patients were enrolled and received at least one dose of study drug. Of 122 patients in the active care group, 47 (39%) stepped-up treatment. At 18 months, endoscopic recurrence occurred in 60 (49%) patients in the active care group and 35 (67%) patients in the standard care group (p=0.03). Complete mucosal normality was maintained in 27 (22%) of 122 patients in the active care group versus four (8%) in the standard care group (p=0.03). In the active care arm, of those with 6 months recurrence who stepped up treatment, 18 (38%) of 47 patients were in remission 12 months later; conversely, of those in remission at 6 months who did not change therapy recurrence occurred in 31 (41%) of 75 patients 12 months later. Smoking (odds ratio [OR] 2.4, 95% CI 1.2-4.8, p=0.02) and the presence of two or more clinical risk factors including smoking (OR 2.8, 95% CI 1.01-7.7, p=0.05) increased the risk of endoscopic recurrence. The incidence and type of adverse and severe adverse events did not differ significantly between patients in the active care and standard care groups (100 [82%] of 122 vs 45 [87%] of 52; p=0.51) and (33 [27%] of 122 vs 18 [35%] of 52; p=0.36), respectively. INTERPRETATION Treatment according to clinical risk of recurrence, with early colonoscopy and treatment step-up for recurrence, is better than conventional drug therapy alone for prevention of postoperative Crohns disease recurrence. Selective immune suppression, adjusted for early recurrence, rather than routine use, leads to disease control in most patients. Clinical risk factors predict recurrence, but patients at low risk also need monitoring. Early remission does not preclude the need for ongoing monitoring. FUNDING AbbVie, Gutsy Group, Gandel Philanthropy, Angior Foundation, Crohns Colitis Australia, and the National Health and Medical Research Council.

Faecal diversion in the management of perianal Crohn’s disease

Aim  Severe perianal Crohn’s disease remains an uncommon but important indication for faecal diversion (FD). The advent of biological therapy such as infliximab for Crohn’s disease is considered to have improved the outcome for these patients. The aim of this study was to assess the outcome of patients undergoing FD for perianal Crohn’s disease and the impact of biological therapy (infliximab).

Efficacy of thiopurines and adalimumab in preventing Crohn's disease recurrence in high‐risk patients – a POCER study analysis

Crohns disease recurs in the majority of patients after intestinal resection.

Postoperative recurrence of Crohn's disease: impact of endoscopic monitoring and treatment step-up.

Aim  Eighty per cent of patients with Crohn’s disease require surgery, of whom 70% will require a further operation. Recurrence occurs at the anastomosis. Although often recommended, the impact of postoperative colonoscopy and treatment adjustment is unknown.

Penile and clitoral stimulation for faecal incontinence: external application of a bipolar electrode for patients with faecal incontinence

Objective  The aim of this study was to assess the effect of a novel pudendal nerve stimulator on clinical and anorectal manometric parameters in patients with faecal incontinence.

Enterocutaneous fistula: a single‐centre experience

Background:  Enterocutaneous fistulae (ECFs) present a difficult management problem and can cause significant morbidity. The aim of the study was to assess the outcome of these patients.

Effect of intestinal resection on quality of life in Crohn's disease.

INTRODUCTION Patients with Crohns disease have poorer health-related quality of life [HRQoL] than healthy individuals, even when in remission. Although HRQoL improves in patients who achieve drug-induced or surgically induced remission, the effects of surgery overall have not been well characterised. METHODS In a randomised trial, patients undergoing intestinal resection of all macroscopically diseased bowel were treated with postoperative drug therapy to prevent disease recurrence. All patients were followed prospectively for 18 months. C-reactive protein [CRP], Crohns Disease Activity Index [CDAI], and faecal calprotectin [FC] were measured preoperatively and at 6, 12, and 18 months. HRQoL was assessed with a general [SF36] and disease-specific [IBDQ] questionnaires at the same time points. RESULTS A total of 174 patients were included. HRQoL was poor preoperatively but improved significantly [p < 0.001] at 6 months postoperatively. This improvement was sustained at 18 months. Females and smokers had a poorer HRQoL when compared with males and non-smokers, respectively. Persistent endoscopic remission, intensification of drug treatment at 6 months, and anti-tumour necrosis factor therapy were not associated with HRQoL outcomes different from those when these factors were not present. There was a significant inverse correlation between CDAI, [but not endoscopic recurrence, CRP, or FC] on HRQoL. CONCLUSION Intestinal resection of all macroscopic Crohns disease in patients treated with postoperative prophylactic drug therapy is associated with significant and sustained improvement in HRQoL irrespective of type of drug treatment or endoscopic recurrence. HRQoL is lower in female patients and smokers. A higher CDAI, but not direct measures of active disease or type of drug therapy, is associated with a lower HRQoL.

Su2092 Clinical Risk Stratification Predicts Development of Endoscopic Recurrence After Crohn's Disease Surgery: Early Results From the POCER Study

G A A b st ra ct s ulcerations at ileocolonoscopy and a history of positive clinical response followed by secondary failure and/or intolerance to at least one TNFα antagonist. Patients randomized in the TNF-K group were receiving TNF-K at days 0, 7, 28, 84 and placebo at days 91 and 112. Patients randomized in the control group were receiving placebo at days 0, 7, 28, and TNFK at days 84, 91 and 112. TNF-K was injected intramuscularly at the dose of 180 mcg per injection. The primary end point was CDAI clinical remission (CDAI≤150) at week 8. Other efficacy end-points included mucosal healing at week 12 and evolution of calprotectin and C-reactive protein. Immune responses were evaluated through titration of anti-TNFα and anti-KLH antibodies. Results: All patients have been recruited. Fewmild or moderate transient local and systemic reactions have been recorded following immunizations. The only serious adverse event reported by the investigator as potentially related to the study drug was a deterioration of CD one month following administration of blinded treatment. There were no other safety concerns. Full analysis is ongoing. Conclusions: Active immunization with TNF-K in patients with Crohns disease is safe. Full immunogenicity and clinical efficacy results will be presented.

CR09 MANAGING FAECAL INCONTINENCE: THE ROLE OF PTQ INJECTIONS

Purpose  An attenuated or disrupted anal sphincter can lead to faecal incontinence. One means of augmenting the sphincter is with the use of the silicone‐based biomaterial PTQ. The aim of this study was to evaluate the effectiveness of PTQ for the symptoms of passive faecal incontinence caused by a weak sphincter mechanism.

Endoscopic balloon dilatation of Crohn's strictures: a safe method to defer surgery in selective cases

Endoscopic balloon dilatation (EBD) provides a valuable alternative to surgery for strictures in Crohns disease (CD). Data are lacking regarding the factors that improve the safety and effectiveness of EBD in CD. The aim of this study is to determine the safety and efficacy of EBD and the clinical variables, which are predictive of successful treatment of CD strictures with EBD.