Ileostomy, Rectal Cancer
Conditions
Brief summary
The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.
Interventions
PROCEDUREDeileostomy
Deileostomy
Sponsors
Vilnius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with temporary ileostomy after rectal resection for rectal cancer * Patients willing to participate in the study
Exclusion criteria
* Anastomosis insufficiency detected clinically or radiologically. * Patients, who are physically and mentally unfit to undergo surgery or to be followed-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | 30 days after surgery | Patients are scored according to the Clavien-Dindo Classification of Surgical Complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization time after ileostomy closure | 30 days after surgery | Hospitalization time |
| 30-days re-admission rate | 30 days after surgery | Re-admission rate during 30 days after re-admission |
| Quality of life of patients after ileostomy closure | at 3, 6, 9 and 12 moths after surgery | Patients quality of life is assessed with EORTC QLQ-C30 questionnaires |
Countries
Lithuania
Outcome results
None listed