Trial reportBMC cancer2015
CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer.
Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Meta-analysis of temporary loop ileostomy closure during or after adjuvant chemotherapy following rectal cancer resection: the dilemma remains.International journal of colorectal disease · 2019Pooled it
- Trial
- Effect and influencing factors of early ileostomy closure 2-4 weeks on patients with rectal cancer.Frontiers in oncology · 2026Article
- Article
- Case report: Secondary peristomal cutaneous squamous cell carcinoma following multimodal treatment for rectal cancer.International journal of surgery case reports · 2025Article
- Increased risk of postoperative complications after delayed stoma reversal: a multicenter retrospective cohort study on patients undergoing anterior resection for rectal cancer.International journal of colorectal disease · 2025Article
- The impact of anastomotic leakage characteristics on the occurrence of anastomotic stenosis after colorectal resection, a retrospective cohort study.International journal of colorectal disease · 2024Article
- Clinical Outcomes of Ileostomy Closure during versus after Adjuvant Chemotherapy in Patients with Rectal Cancer.Canadian journal of gastroenterology & hepatology · 2024Article
- Clinical Outcomes of Ileostomy Closure before Adjuvant Chemotherapy after Rectal Cancer Surgery: An Observational Study from a Chinese Center.Gastroenterology research and practice · 2021Article
- Risk factors for postoperative ileus following loop ileostomy closure.Turkish journal of surgery · 2020Article
- Functional outcome following rectal surgery-predisposing factors for low anterior resection syndrome.International journal of colorectal disease · 2017Article
- Tolerability and Adverse Events of Adjuvant Chemotherapy for Rectal Cancer in Patients With Diverting Ileostomy.In vivo (Athens, Greece)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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. DISCUSSION: The 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 2013.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.