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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Peshawar, Pakistan, 25000
- Lady Reading Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Early Ileostomy Closure
Participants undergo ileostomy closure within 8 weeks of ileostomy creation following bowel surgery.
|
Surgical reversal of temporary ileostomy performed within 8 weeks after ileostomy creation.
|
|
Aktiv komparator: Delayed Ileostomy Closure
Participants undergo ileostomy closure more than 8 weeks after ileostomy creation following bowel surgery.
|
Surgical reversal of temporary ileostomy performed more than 8 weeks after ileostomy creation.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Post-operative hospital stay
Tidsram: From the date of ileostomy closure until hospital discharge (up to 30 days).
|
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.
|
From the date of ileostomy closure until hospital discharge (up to 30 days).
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LRH-85-2025-ILEO
- IRB Ref. No. 85/LRH/MTI (06-Fe (Annan identifierare: Lady Reading Hospital)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .