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Loop Ileostomy Closure as a 23-hour Stay Procedure, a Multi-center Randomized Controlled Trial

NCT03941522 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-06-12

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and feasibility of ileostomy closure performed in a 23 hours hospitalization setting, using a multi-center, open-label, randomized controlled trial comparing patients being hospitalized overnight (discharged on the day after surgery) to patients being hospitalized as per the current conventional care after ileostomy closure with both groups following a standardized enhanced recovery after surgery (ERAS) pathway specific to ileostomy closure. Primary outcome will be total length of hospital stay in days and secondary outcomes, measured at 30 days, will include readmission rate, postoperative complication rate minor and severe, postoperative ileus rate, postoperative surgical site infection rate and mortality rate.

Conditions

  • Ileostomy - Stoma

Interventions

OTHER

Early discharge from hospital

Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • François Letarte, MD, MSc · CHU de Québec-Université Laval

  • Xavier Paré, MD · CHU de Québec-Université Laval

  • Geneviève Morin, MD · CHU de Québec-Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2021-04-30
Completion
2021-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941522 on ClinicalTrials.gov