Ileostomy Closure in Rectal Cancer
Conditions
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.
Interventions
PROCEDUREileostoma closure
The operation procedure is standardized as described above (see group description).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 have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks.
Sponsors
Uppsala University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with complications | 30 days |
| Number of patients re-admitted | 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 |
Countries
Sweden
Outcome results
None listed