HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia

Background Parastomal hernia (PSH) can be repaired surgically, but results to date have been disappointing, with reported recurrence rates of 30 to 76%. Other types of intervention are therefore needed to improve the quality of life of people with PSH. One potential intervention is physical activity. We hypothesise that the intervention will increase core activation and control across the abdominal wall at a site of potential weakness and thus reduce the risk of PSH progression. Increases in physical activity will improve body image and quality of life (QoL). Methods Subjects and sample There were approximately 20 adults with a bowel stoma and PSH. People with previous PSH repair will be excluded as well as people who already do core training. Study design This is a feasibility study of a randomised controlled trial with 2 months follow-up, in 2 sites using mixed methods. Stage 1 involves intervention development and in stage 2, intervention and trial parameters will be assessed. Intervention A theoretically informed physical activity intervention was done, targeting people with PSH. Main outcome of feasibility study The main outcome is the decision by an independent Study Steering Committee whether to proceed to a full randomised controlled trial of the intervention. Other outcomes We will evaluate 4 intervention parameters—fidelity, adherence, acceptability and safety and 3 trial parameters (eligible patients’ consent rate, acceptability of study design and data availability rates for following endpoints): I. Diagnosis and classification of PSH II. Muscle activation III. Body composition (BMI, waist circumference) IV. Patient reported outcomes: QoL, body image and physical functioning V. Physical activity; VI. Psychological determinants of physical activity Other data Included are other data such as interviews with all participants about the intervention and trial procedures. Data analysis and statistical power As this is a feasibility study, the quantitative data will be analysed using descriptive statistics. Audio-recorded qualitative data from interviews will be transcribed verbatim and analysed thematically. Discussion The feasibility and acceptability of key intervention and trial parameters will be used to decide whether to proceed to a full trial of the intervention, which aims to improve body image, quality of life and PSH progression. Trial registration ISRCTN1520759

Manejo das hérnias paraestomais Management of paraestomal hernias

INTRODUÇÃO: A hérnia paraestomal representa complicação tardia de virtualmente todos os estomas intestinais. As manifestações clínicas oscilam desde um simples problema estético até o estrangulamento do conteúdo herniado. O grau de incapacidade produzido pela hérnia é variável. Existe gama muito grande de procedimentos utilizando ou não material protético de variada especificidade e de resultados controversos. MÉTODOS: Foi realizada revisão de literatura nos sites de pesquisa PubMed, Bireme e Scielo, com os descritores hérnias paraestomais, tratamento cirúrgico, hérnia, colostomia e ileostomia. Selecionaram-se, principalmente, os estudos de aplicação de técnicas cirúrgicas e adicionou-se a experiência clínica dos autores. CONCLUSÃO: Apesar das várias técnicas e meios à disposição do cirugião para o manuseio das hérnias paraestomais, ainda não há método ideal que venha a ser recomendado para todos os casos. Assim, a análise criteriosa dos fatores de riscos do paciente pode ajudar a escolher a melhor opção de tratamento que deve ser individualizada a cada caso.<br>INTRODUCTION: Paraestomal hernia represents a late complication of virtually all intestinal stoma. Clinical manifestations range from a simple cosmetic problem to the strangulation of the herniated contents. The degree of disability produced by the hernia is variable. There is a wide range of procedures using or not using prosthetic material of different specificity and controversial results. METHODS: Was performed a literature review on sites PubMed, BIREME, SciELO with the headings paraestomal hernias, surgery, hernia, colostomy and ileostomy. Were selected mainly studies with the application of surgical techniques and added to the authors' clinical experience. CONCLUSION: Despite various techniques and available devices to handle the paraestomal hernias, there is no ideal method that may be recommended for all cases. Thus, a careful analysis of risk factors can choose the best treatment option that should be done individualizely to each case