Clinical trial · Observational
Day-Case Closure of Loop Ileostomy in Rectal Cancer
Day-Case Closure of Ileostomy: A Pilot Study
NCT02774447CI-TRIAL-00044542completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate if day-case closure of ileostomy is feasible and safe.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ileostomy Closure in Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ileostoma closure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Procedure: ileostoma closure
Primary outcomes (4)
- measure
- Number of patients with complications
- timeFrame
- 30 days
- measure
- Number of patients re-admitted
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAfshari 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. PMID 34224302