Day-Case Closure of Loop Ileostomy in Rectal Cancer

Ileostomy Closure in Rectal Cancer Clinical Trial

Official title:

Day-Case Closure of Ileostomy: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774447
• Other study ID #: Dnr 2014/363
• Status: Completed
• Start date: August 2015
• Est. completion date: March 2020

Study information

• Verified date: April 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ileostomy Closure in Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• ileostoma 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.

Locations

Country	Name	City	State
Sweden	Landstinget Västmanland,Centrum för klinisk forskning	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complications		30 days
Primary	Number of patients re-admitted		30 days
Primary	Number of patients re-operated		30 days
Primary	Number of patients who were able to return home after day-case closure of loop-ileostomy		24 houres