Early vs Standard Ileostomy Reversal
Early Ileostomy Reversal at Two Months Versus Three Months: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This open-label randomized controlled trial was conducted at Gulab Devi Teaching Hospital, Lahore, Pakistan, between August 2025 and January 2026 to compare early versus standard timing of ileostomy reversal. Patients aged 14 to 55 years with a protective loop ileostomy following colorectal surgery and radiologically confirmed anastomotic healing were enrolled. Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at approximately 8 weeks (early group) or 12 weeks (standard group).
The primary outcome was the rate of postoperative complications occurring during the index hospital admission following ileostomy reversal. Secondary outcomes included length of hospital stay, time to first oral intake, time to return to normal activities, patient-reported comfort using a visual analogue scale, and 30-day readmission rates.
All procedures were performed using a standardized surgical technique by experienced surgeons within the same unit. Statistical analysis was performed using appropriate tests for continuous and categorical variables, with a significance threshold of p<0.05.
The study aimed to evaluate whether earlier ileostomy reversal is safe and associated with improved recovery outcomes in a resource-limited tertiary care setting.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Gulab Devi Teaching Hospital, Lahore, Pakistan
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion criteria
- Age 14-55 years Protective loop ileostomy Radiologically confirmed anastomotic healing
Exclusion Criteria:
- Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Early Reversal
Ileostomy reversal performed at approximately 8 weeks
|
Surgical closure of loop ileostomy
|
|
Aktiv komparator: Standard Reversal
Ileostomy reversal performed at approximately 12 weeks
|
Surgical closure of loop ileostomy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Postoperative complication rate
Tidsramme: From enrollment to end of study at 6 months
|
From enrollment to end of study at 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Length of hospital stay
Tidsramme: From enrollment to the end of study at 6 months
|
From enrollment to the end of study at 6 months
|
|
Time to oral intake
Tidsramme: From enrollment to the discharge of patient which was upto 2 weeks
|
From enrollment to the discharge of patient which was upto 2 weeks
|
|
Return to normal activities
Tidsramme: From enrollment to end of study at 6 months
|
From enrollment to end of study at 6 months
|
|
Patient comfort score
Tidsramme: From enrollment to the discharge of patient which was upto 2 weeks
|
From enrollment to the discharge of patient which was upto 2 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GDTH-IR-2025-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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