Day-Case Closure of Loop Ileostomy in Rectal Cancer

Uppsala University

Status: Completed

Conditions: Ileostomy Closure in Rectal Cancer

Treatments: Procedure: ileostoma closure

Study type: Observational

Funder types: Other

Identifiers

NCT02774447

Dnr 2014/363

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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
• 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

Trial design

30 participants in 1 patient group

Rectal cancer patients with ileostoma

Description:

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.

Treatment:

Procedure: ileostoma closure