Ileostomy, Rectal Cancer
Conditions
Keywords
Chemotherapy, Adjuvant, Early closure, Late closure
Brief summary
This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). After a curative resection for rectal cancer and temporary ileostomy, 270 patients with indication to adjuvant chemotherapy will be randomized to early (before starting adjuvant treatment) or late (after adjuvant treatment completion) stoma closure. Primary end point will the compliance to adjuvant therapy. Secondary endpoint will include quality of life and bowel function evaluation, postoperative morbidity, chemotherapy toxicity, oncological outcomes and costs comparison.
Detailed description
Diverting ileostomy is effective in reducing severity of anastomotic complications in rectal low anterior resections and it is therefore widely used especially after neoadjuvant chemoradiation treatment. In current clinical practice, in patients with indication to adjuvant chemotherapy, closure of ileostomy is usually performed after the end of the treatment. However, a prolonged presence of the ostomy can induce the onset of ostomy-related complications such as stoma prolapse, parastomal hernia, mechanical ileus, high flow dehydration and damage to renal function. The ostomy-related complications may require unplanned or prolonged hospitalization, thus increasing costs. Furthermore, the presence of the stoma may affect quality of life, causing alteration of the body image and imposing changes in the daily routine and lifestyle. Early closure of the ileostomy in patients without signs of postoperative fistula has therefore been proposed. Outcomes of early closure (within one month from surgery) of diverting ileostomy were demonstrated to be equal to those of late closure (more than 12 weeks from surgery) in 2 randomized trials. Early closure may favor a better quality of life for patients, shortening the life-period with ileostomy, reduces health system economic expenditure and may represent the most desirable and convenient choice. It was also associated with better long term functional results in a randomized trial. In patients with indication to adjuvant therapy, however, timing to closure of the ostomy (before the start, during or at the end of treatment) is still a matter of debate in terms of compliance to systemic treatment, quality of life and overall costs. A recent multicenter retrospective study reported an increase in gastrointestinal toxicity in ostomy patients with a significant reduction in treatment compliance. On the other hand, early closure of the ostomy could unmask anterior resection syndrome (LARS) before chemotherapy, with potential negative impact on the tolerability of the treatment, or reveal postoperative complications thus delaying chemotherapy treatment. The trial will investigate which is the best strategy of dealing with temporary ileostomy in relation to adjuvant therapy.
Interventions
OTHERTiming of stoma closure
Defining the best timing of stoma closure in relation to adjuvant therapy compliance
Sponsors
Rete Oncologica Piemonte, Valle d'Aosta
Ospedale Umberto I di Torino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Multicenter controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient treated with a curative resection for rectal cancer * Presence of a temporary ileostomy * Age \>= 18 years * Indication to adjuvant treatment * Absence of anastomotic dehiscence (as proved by enema and/or endoscopy) * Able to give written informed consent
Exclusion criteria
* ASA \>3 * ECOG Performance Status \>=2 * UICC stage IV * Severe and non-controlled systemic, oncologic, or infectious disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with good compliance to adjuvant therapy | Measured within 48 hours after the end of the last cycle of adjuvant therapy | Composite outcome measure including timeliness and percentage of planned dose received. In each subject, treatment compliance is defined as good if both the following conditions are met: 1. adjuvant therapy starting date within 10 weeks of rectal resection; 2. total cumulative received dose (mg/m2) \>=70% of planned. The percentage of participants with good compliance in both arms will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of chemotherapy side effects | Immediately after the end of every single cycle (each cycle duration varies from 5 to 14 days according to the chosen scheme) | According to CTCAE classification |
| Quality of life 1 | At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization | Measured by EORTC C30 |
| Quality of life 2 | At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization | Measured by EORTC CR29 |
| Quality of life 3 | At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization | Measured by EQ-5D-3L |
| Rate of stoma-related complications | All over the study duration (up to 12 months from randomization) | Adverse events related to the presence of stoma and postoperative complication after stoma closure |
| Overall survival | Ut to 3 years from inclusion of the last patient | From randomization date to death from any cause or date of last contact |
| Progression free survival | Ut to 3 years from inclusion of the last patient | From randomization date to progression diagnosis or date of last contact |
| Costs analysis | At 12 months from randomization | Mean cumulative costs in euro of the postoperative phase including outpatient visits, hospital stay for stoma closure, hospital re-entry and expenditures for stoma care appliances based on life-days with the stoma. Excluded are costs related to adjuvant treatment. |
| Bowel function | At 12 months from rectal resection | Measured by LARS (Low Anterior Resection Syndrome) score |
Countries
Italy
Outcome results
None listed