Day-Case Closure of Loop Ileostomy in Rectal Cancer

Completed

• Conditions: Ileostomy Closure in Rectal Cancer

• Registration Number: NCT02774447
• Lead Sponsor: Uppsala University

Brief 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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
• Other intraoperative difficulties leading to suspected increased risk of complication

Discharge criteria:

• Stable vital parameters regarding circulation and respiration
• No sign of bleeding
• Pain relief possible through per oral administration
• Emptied urinary bladder
• Able to maintain per oral nutrition
• Mobilization possible
• Obtained oral and written information about symptoms of sepsis and bowel obstruction
• Obtained telephone number of a contact-nurse
• Obtained time for wound-inspection at the surgical unit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients re-operated	30 days
Number of patients who were able to return home after day-case closure of loop-ileostomy	24 houres
Number of patients with complications	30 days
Number of patients re-admitted	30 days

Trial Locations

Locations (1)

Landstinget Västmanland,Centrum för klinisk forskning; 🇸🇪 Västerås, Sweden