Early Versus Delayed Ileostomy Closure Following Bowel Surgery (EDIC)
Comparison of Mean Post-Operative Hospital Stay in Early and Delayed Ileostomy Closure Following Bowel Surgery: A Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Temporary ileostomy is frequently performed after bowel surgery as a protective measure for intestinal anastomosis or as part of emergency surgical management. Although ileostomy closure is considered a routine procedure, the ideal timing of closure remains uncertain. Early closure has the potential to improve patient quality of life, reduce stoma-related complications, and shorten the overall treatment course. Conversely, delayed closure may provide additional time for recovery and anastomotic healing but may increase the duration of stoma-related morbidity and healthcare resource utilization.
This prospective, randomized controlled trial will be conducted in the Department of General Surgery, Lady Reading Hospital-Medical Teaching Institution, Peshawar, Pakistan. A total of 60 adult patients (18-65 years) with temporary ileostomy following bowel surgery who meet the eligibility criteria will be enrolled using consecutive sampling and randomized in a 1:1 ratio into two study groups using block randomization.
Participants in the intervention group will undergo early ileostomy closure within 8 weeks of ileostomy creation, while participants in the comparator group will undergo delayed ileostomy closure after 8 weeks. The primary outcome will be post-operative hospital stay, measured as the number of days from ileostomy closure surgery until hospital discharge.
Baseline demographic and clinical characteristics, including age, sex, body mass index, smoking status, hypertension, diabetes mellitus, residence, financial background, and post-operative complications, will be recorded. Data will be analyzed using IBM SPSS version 25. Continuous variables will be analyzed using the independent-samples t-test or Mann-Whitney U test according to data distribution, with statistical significance set at p < 0.05.
The study has received ethical approval from the Institutional Review Board of Lady Reading Hospital-Medical Teaching Institution, Peshawar (IRB Reference No. 85/LRH/MTI, dated 06 February 2025). The results are expected to provide evidence regarding the optimal timing of temporary ileostomy closure in terms of reducing post-operative hospital stay and improving clinical outcomes.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Peshawar, Paquistão, 25000
- Lady Reading Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria
- Adults aged 18-65 years.
- Male or female participants.
- Patients with a temporary ileostomy following bowel surgery.
- Patients scheduled for elective ileostomy closure.
- Participants willing to provide written informed consent.
Exclusion Criteria
- Abdominal wall dehiscence.
- Tubercular perforation.
- Peritoneal contamination.
- Patients medically unfit for surgery.
- Refusal to provide informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Early Ileostomy Closure
Participants undergo ileostomy closure within 8 weeks of ileostomy creation following bowel surgery.
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Surgical reversal of temporary ileostomy performed within 8 weeks after ileostomy creation.
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Comparador Ativo: Delayed Ileostomy Closure
Participants undergo ileostomy closure more than 8 weeks after ileostomy creation following bowel surgery.
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Surgical reversal of temporary ileostomy performed more than 8 weeks after ileostomy creation.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Post-operative hospital stay
Prazo: From the date of ileostomy closure until hospital discharge (up to 30 days).
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Post-operative hospital stay will be measured as the number of days from ileostomy closure surgery until discharge from the hospital.
The mean duration will be compared between patients undergoing early (≤8 weeks) and delayed (>8 weeks) ileostomy closure.
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From the date of ileostomy closure until hospital discharge (up to 30 days).
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LRH-85-2025-ILEO
- IRB Ref. No. 85/LRH/MTI (06-Fe (Outro identificador: Lady Reading Hospital)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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