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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Peshawar, Pakistan, 25000
- Lady Reading Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Post-operative hospital stay
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- LRH-85-2025-ILEO
- IRB Ref. No. 85/LRH/MTI (06-Fe (Andere identificatie: Lady Reading Hospital)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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