Day-Case Closure of Loop Ileostomy in Rectal Cancer

Completed

• Conditions: Ileostomy Closure in Rectal Cancer
• Interventions: Procedure: ileostoma closure

• 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

Arm && Interventions

Group	Intervention	Description
Rectal cancer patients with ileostoma	ileostoma closure	In association with anterior resection of rectal cancer these patients obtain loop-ileostoma in order to avoid complications. These are closed within a few months and according to previous studies the admission time is 3-5 days after operation. This study is a single-arm study. The arm include patients having had rectal cancer operation and who have obtained a loop-ileostoma and that meet the inclusion criteria. The operation procedure is standardized; shortly described by dissecting the ileostoma from the abdominal wall and everting the stoma ledges, which will be sutured or stapled. The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will be followed up.

Primary Outcome Measures

Name	Time	Method
Number of patients with complications	30 days
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 re-admitted	30 days

Trial Locations

Locations (1)

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