Ileostomy, Rectal Cancer Clinical Trial
| NCT number | NCT03796702 |
| Other study ID # | 1 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 1, 2011 |
| Est. completion date | December 30, 2018 |
| Verified date | April 2023 |
| Source | Vilnius University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 86 |
| Est. completion date | December 30, 2018 |
| Est. primary completion date | November 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Lithuania | National Cancer Institute | Vilnius |
| Lead Sponsor | Collaborator |
|---|---|
| Vilnius University |
Lithuania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative morbidity | Patients are scored according to the Clavien-Dindo Classification of Surgical Complications. | 30 days after surgery | |
| Secondary | Hospitalization time after ileostomy closure | Hospitalization time | 30 days after surgery | |
| Secondary | 30-days re-admission rate | Re-admission rate during 30 days after re-admission | 30 days after surgery | |
| Secondary | Quality of life of patients after ileostomy closure | Patients quality of life is assessed with EORTC QLQ-C30 questionnaires | at 3, 6, 9 and 12 moths after surgery |