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Day-Case Closure of Loop Ileostomy in Rectal Cancer | Clinical Trials | Clareo Health

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Day-Case Closure of Loop Ileostomy in Rectal Cancer

Day-Case Closure of Ileostomy: A Pilot Study

NCT02774447•Uppsala University

View on ClinicalTrials.gov

Summary

The aim of this study is to investigate if day-case closure of ileostomy is feasible and safe.

Detailed Description

For all patients that match the inclusion criteria a registration-protocol is completed. Then the patients are operated and a surgery-protocol is completed. The patients are observed for maximum 24 h and discharged if they meet the discharge-criteria. 30 days post-operative the investigators do a follow-up of complications.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults not older than 80 planed for closure of ileostomy
•The patient should not have had the ileostomy for more than 1 year
•Informed written consent should be given
•The patient should have a phone
•Should have an adult supervision at home for the first 24 hours after discharge
•American Society of Anesthesiologists (ASA) classification 1-2

Exclusion Criteria

•ASA classification 3 and above
•The pre-operative investigation have shown anastomosis leakage or stricture
•Dementia or other cognitive dysfunction
•The need of an interpreter
•Patients assessed not being able to manage themselves at home post-operative
•Insulin treated diabetes
•Coagulopathy
•Other organ dysfunction
•Bleeding more than 300 ml
•If converted to laparatomy
+11 more criteria

Locations (1)

Landstinget Västmanland,Centrum för klinisk forskning

Västerås, Sweden

Key Dates

Start Date

August 1, 2015

Primary Completion Date

March 1, 2020

Completion Date

March 1, 2020

Last Updated

April 8, 2020

Enrollment

ACTUAL participants

Conditions

Ileostomy Closure in Rectal Cancer

Interventions

ileostoma closure

PROCEDURE