Abstract
BackgroundCurrent evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage. However, relevant stoma morbidity after rectal cancer surgery exists and has a significant impact on quality of life. Moreover, a diverting stoma has an influence on completeness of chemotherapy but it remains unclear in which way. There is no evidence regarding optimal timing for stoma closure in relation to adjuvant chemotherapy. Two randomised controlled trials have studied early stoma closure after low anterior resection in patients with rectal cancer, one of them showing that early closure around day 8 after resection is possible without increasing morbidity.Methods/DesignCoCStom is a randomised multicentre trial comparing completeness of adjuvant chemotherapy as primary endpoint after early (8–10 days after resection, before starting adjuvant therapy) versus late (~26 weeks after resection and completion of adjuvant therapy) stoma closure in patients with locally advanced rectal cancer undergoing low anterior resection after neoadjuvant therapy. After exclusion of post-operative anastomotic leakage 257 patients from 30 German hospitals are planned to be included in order to assure a power of 80 % for the confirmatory analysis of at least 214 evaluable cases. An absolute increase of 20 % for the rate of completely administered adjuvant chemotherapy is regarded as a clinically meaningful step forward and serves as basis for sample size calculation. Quality of life, stoma-related complications, individual completeness of chemotherapy rate, percentage of patients stopping adjuvant therapy or undergoing dose modifications or delay, oncological outcomes, cumulative days of hospitalisation and number of readmissions, rate of symptomatic anastomotic leaks after stoma closure, mortality, post-operative complications and toxicity of adjuvant chemotherapy are secondary endpoints.DiscussionThe CoCStom trial aims to clarify optimal timing of stoma closure in the context of adjuvant chemotherapy. Depending on the results of the trial, patients could benefit either from early or late stoma closure in regard to long term oncological survival due to a higher rate of completeness of adjuvant chemotherapy treatment and thus better effectiveness.Trial registrationGerman Clinical Trials Register, DRKS00005113. Registered 28 August 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-015-1838-0) contains supplementary material, which is available to authorized users.
Highlights
Current evidence supports a diverting stoma in patients undergoing low anterior resection with total mesorectal excision for rectal cancer as it reduces clinical severity of anastomotic leakage
It seems advantageous to close the stoma as early as possible, but on the other hand early closure may result in more complications which may impair the administration of all planned cycles of adjuvant chemotherapy
Whether the time point of stoma closure influences the complete administration of the planned adjuvant chemotherapy, in patients with locally advanced rectal cancer undergoing Low anterior resection (LAR) with total mesorectal excision (TME) after neoadjuvant therapy, remains unclear
Summary
Whether the time point of stoma closure influences the complete administration of the planned adjuvant chemotherapy, in patients with locally advanced rectal cancer undergoing LAR with TME after neoadjuvant therapy, remains unclear. That early stoma closure is an important issue in the complex therapy of rectal cancer patients is confirmed by a newly started prospectively randomised Scandinavian multicentre study [32] It compares early closure versus standard treatment (8–13 days vs 12–26 weeks after surgery) with postsurgical morbidity as primary endpoint, QoL and the socio-economic effects of early closure as secondary endpoints. Since early stoma closure is possible without increase in preoperative mortality and the complete administration of the planned chemotherapy cycles potentially improves the oncological outcome, it remains to be determined how early stoma closure influences CoC This is the primary goal of the CoCStom trial and will contribute to clarifying how the largest benefit from adjuvant therapy can be gained for the affected patients.
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