Prospective, randomised, multicentre, open-label trial, designed to evaluate the best timing of closure of the temporary ileostomy (early versus late) in patients who underwent rectal cancer resection and with indication for adjuvant chemotherapy: the STOMAD (STOMa closure before or after ADjuvant therapy) randomised controlled trial.

INTRODUCTION: Temporary ileostomy is a valuable aid in reducing the severity of complications related to rectal cancer surgery. However, it is still unclear what is the best timing of its closure in relation to the feasibility of an adjuvant treatment, especially considering patient-reported outcomes and health system costs. The aim of the study is to compare the results of an early versus late closure strategy in patients with indication to adjuvant chemotherapy after resection for rectal cancer. METHODS AND ANALYSIS: This is a prospective multicentre randomised trial, sponsored by Rete Oncologica Piemonte e Valle d'Aosta (Oncology Network of Piedmont and Aosta Valley-Italy). Patients undergone to rectal cancer surgery with temporary ileostomy, aged >18 years, without evidence of anastomotic leak and with indication to adjuvant chemotherapy will be enrolled in 28 Network centres. An early closure strategy (between 30 and 40 days from rectal surgery) will be compared with a late one (after the end of adjuvant therapy). Primary endpoint will be the compliance to adjuvant chemotherapy with and without ileostomy. Complications associated with stoma closure as well as quality of life, costs and oncological outcomes will be assessed as secondary endpoints. ETHICS AND DISSEMINATION: The trial will engage the Network professional teams in a common effort to improve the treatment of rectal cancer by ensuring the best results in relation to the most correct use of resources. It will take into consideration both the patients' point of view (patient-reported outcome) and the health system perspective (costs analysis). The study has been approved by the Ethical Review Board of Città della Salute e della Scienza Hospital in Turin (Italy). The results of the study will be disseminated by the Network website, medical conferences and peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT04372992.

Leiomyosarcoma of the inferior vena cava. Report of two cases and review of the literature.

INTRODUCTION: Leiomyosarcoma (LMS) occurs most frequently in the inferior vena cav (IVC). Since Perl's first description in 1871, about 300 cases of IVX have been reported in English literature. The Authors present their personal experience of two case of IVC leiomyosarcoma treated in their Institution. PATIENTS AND METHODS: Clinical and pathologic data, surgical management, ourcomes and follow-up of two patients admitted nb the Authors' Division respectively on February and November 2004 were collected. RESULTS: There were a 49-years-old female with rare epigastric pain and a 42-years-old female with one-month history of abdominal discomfort and weight loss. After preoperative evaluation, both of the patients had localised and resectable tumors and underwent radical surgical excision, with prosthetic replacement of the IVC in the first patient and ligation of the IVC in the other one. The first patient is still alive but in an advanced disease. The second patient died of recurrence at seven months. DISCUSSION: LMS of IVC is a rare tumor. The diagnosis is often delayed because of non-specificic symptoms. Radical resection with surgical margins free of tumor is the treatment of choice. The extent of venous resection does not seem to affect the survival. The type of IVC reconstruction is based on the extent of venal wall involvement. The prognosis is often poor because of tumor recurrence and/or metastatic disease. The role of chemo and radio therapy is not clear yet. CONCLUSION: Long term survival is related to an extensive surgery, being surgical margins free of tumor the only prognostic factor with significant influence on patients survival.