Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results.</p> <p>Methods</p> <p>DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40).</p> <p>Discussion</p> <p>HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life.</p> <p>Trial registration</p> <p>British registry (ISRCTN) for clinical trials <a href="http://www.controlled-trials.com/ISRCTN82208287">ISRCTN82208287</a><url>http://www.controlled-trials.com/ISRCTN82208287</url></p

Determinants of female sexual function in inflammatory bowel disease: a survey based cross-sectional analysis

<p>Abstract</p> <p>Background</p> <p>Sexual function is impaired in women with inflammatory bowel disease (IBD) as compared to normal controls. We examined disease specific determinants of different aspects of low sexual function.</p> <p>Methods</p> <p>Women with IBD aged 18 to 65 presenting to the university departments of internal medicine and surgery were included. In addition, a random sample from the national patients organization was used (separate analyses). Sexual function was assessed by the Brief Index of Sexual Function in Women, comprising seven different domains of sexuality. Function was considered impaired if subscores were < -1 on a z-normalized scale. Results are presented as age adjusted odds ratios with 95% CI based on multiple logistic regression.</p> <p>Results</p> <p>336 questionnaires were included (219 Crohn's disease, 117 ulcerative colitis). Most women reported low sexual activity (63%; 17% none at all, 20% moderate or high activity). Partnership satisfaction was high in spite of low sexual interest in this group. Depressed mood was the strongest predictor of low sexual function scores in all domains. Urban residency and higher socioecomic status had a protective effect. Disease activity was moderately associated with low desire (OR 1.8, 95% CI 1.0 to 3.2). Severity of the disease course impacted most on intercourse frequency (OR 2.3, 95% CI 1.4 to 4.7). Lubrication problems were more common in smokers (OR 2.5, 95% CI 1.3 to 5.1).</p> <p>Conclusion</p> <p>Mood disturbances and social environment impacted more on sexual function in women with IBD than disease specific factors. Smoking is associated with lubrication problems.</p

Development of a core descriptor set for Crohn's anal fistula

AIM: Crohn's anal fistula (CAF) is a complex condition, with no agreement on which patient characteristics should be routinely reported in studies. The aim of this study was to develop a core descriptor set of key patient characteristics for reporting in all CAF research. METHOD: Candidate descriptors were generated from published literature and stakeholder suggestions. Colorectal surgeons, gastroenterologists and specialist nurses in inflammatory bowel disease took part in three rounds of an international modified Delphi process using nine-point Likert scales to rank the importance of descriptors. Feedback was provided between rounds to allow refinement of the next ratings. Patterns in descriptor voting were assessed using principal component analysis (PCA). Resulting PCA groups were used to organize items in rounds two and three. Consensus descriptors were submitted to a patient panel for feedback. Items meeting predetermined thresholds were included in the final set and ratified at the consensus meeting. RESULTS: One hundred and thirty three respondents from 22 countries completed round one, of whom 67.0% completed round three. Ninety seven descriptors were rated across three rounds in 11 PCA-based groups. Forty descriptors were shortlisted. The consensus meeting ratified a core descriptor set of 37 descriptors within six domains: fistula anatomy, current disease activity and phenotype, risk factors, medical interventions for CAF, surgical interventions for CAF, and patient symptoms and impact on quality of life. CONCLUSION: The core descriptor set proposed for all future CAF research reflects characteristics important to gastroenterologists and surgeons. This might aid transparent reporting in future studies

Appropriateness of use of infliximab in the Swiss IBD Cohort Study

Introduction: Anti-TNFs have significantly improved the management of Crohn's disease (CD), but not all patients will benefit from this therapy. We used data from the Swiss IBD Cohort Study (SIBDCS) and preset appropriateness criteria to examine the appropriateness of use of infliximab (IFX) in CD patients. aims &amp; methods: EPACT II (European Panel on the Appropriateness of Crohn's disease Therapy) appropriateness criteria (www.epact.ch) have been developed by a formal panel process combining evidence from the published literature and expert opinion (end 2007), yielding 3 categories of indications: appropriate, uncertain, and inappropriate. Enrolment and follow-up of all SIBDCS patients were achieved with questionnaires relating to EPACT II criteria. Patients could correspond to several clinical categories; pregnant patients or those with stenosing disease could not be assessed using EPACT II criteria. A step-by-step analysis based on frequency allowed identification of the most appropriate indication for IFX in a given patient. results: 822 CD patients were included between November 2006 and March 2009. 146 patients (18%) were on IFX at inclusion (130 maintenance of remission, 16 new treatments). At inclusion, and in comparison with non-IFX treated patients, patients on infliximab were more frequently female (56% vs 51%), younger at diagnosis (27.4 years old vs 30.4) and had a slightly shorter disease duration (10.3 years vs 11.7). Disease extension was greater in these patients, who were mainly treated in university centres (83% vs 72%). IFX therapy was considered appropriate in 47%, uncertain in 36% and inappropriate in 18 % of patients (6% of situations could not be assessed). conclusion: In this cohort, most indications (47%) for IFX therapy were appropriate. Uncertain or inappropriate indications were mostly due to complex patient characteristics (e.g. complex fistulas, history of multiple drug-failures), which reflect the broad use of IFX in clinical practice. Cohort studies are well suited to evaluating the implementation of new scientific evidence in clinical practice

Challenges of nurse delivery of psychological interventions for long-term conditions in primary care: a qualitative exploration of the case of chronic fatigue syndrome/myalgic encephalitis

Background The evidence-base for a range of psychosocial and behavioural interventions in managing patients with long term conditions (LTCs) is now well-established. With increasing numbers of such patients with such conditions being managed in primary care, and a shortage of specialists in psychology and behavioural management to deliver interventions, such therapeutic interventions are increasingly being delivered by general nurses with limited training in psychological interventions. It is unknown what issues this raises for the nurses or their patients. The purpose of the study was to examine the challenges faced by non-specialist nurses when delivering psychological interventions for a long term condition (Chronic Fatigue Syndrome /Myalgic Encephalomyelitis; CFS/ME) within a primary care setting. Methods A qualitative study nested within a randomised controlled trial [ISRCTN 74156610] explored the experiences and acceptability of two different psychological interventions (pragmatic rehabilitation and supportive listening) from the perspectives of nurses, their supervisors and patients. Exploring data from each perspective provides triangulation, and therefore increased trustworthiness, of the analysis. Semi-structured in-depth interviews were conducted with 46 patients, three nurse therapists and three supervisors and an iterative approach was used to develop conceptual categories from the dataset. Results Analyses reveal four sets of challenges that were common to both interventions: i) Being a novice therapist; ii) engaging patients in the therapeutic model; iii) dealing with emotions and iv) complexity of primary care. Each challenge had the potential to cause tension between therapist and patient. A number of strategies were developed by participants to manage the tensions. Conclusion Tensions exist for nurses when attempting to deliver psychological therapy for patients with CFS/ME in a primary care trial which would need to be addressed before implementing within routine clinical practice. Similar tensions may be found for other long term conditions. These have implications for developing therapeutic alliance and highlight the need for regular supervision