Day-Case Closure of Loop Ileostomy in Rectal Cancer

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

Detailed Description
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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.

Official Title
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Day-Case Closure of Ileostomy: A Pilot Study

Conditions
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Ileostomy Closure in Rectal Cancer

Intervention / Treatment
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* Procedure: ileostoma closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rectal cancer patients with ileostoma<br>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. | Procedure: ileostoma closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |