Clinical trial NCT02774447: Day-Case Closure of Loop Ileostomy in Rectal Cancer
Official title: Day-Case Closure of Ileostomy: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ileostomy Closure in Rectal Cancer
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients earlier operated at the local hospital, who are now planned for closure of ileostomy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with complications
timeFrame: 30 days
measure: Number of patients re-admitted
timeFrame: 30 days
measure: Number of patients re-operated
timeFrame: 30 days
measure: Number of patients who were able to return home after day-case closure of loop-ileostomy
timeFrame: 24 houres
Secondary outcomes:
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Landstinget Västmanland,Centrum för klinisk forskning
Study officials:
affiliation: Centrum for Clinical Research Västerås/Uppsala University
name: Abbas Chabok, Phd, MD
role: STUDY_DIRECTOR
References:
citation: Afshari K, Nikberg M, Smedh K, Chabok A. Loop-ileostomy reversal in a 23-h stay setting is safe with high patient satisfaction. Scand J Gastroenterol. 2021 Sep;56(9):1126-1130. doi: 10.1080/00365521.2021.1947367. Epub 2021 Jul 5.