Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study.

BACKGROUND: T1 colorectal cancer (CRC) without histological high-risk factors for lymph node metastasis (LNM) can potentially be cured by endoscopic resection, which is associated with significantly lower morbidity, mortality and costs compared to radical surgery. An important prerequisite for endoscopic resection as definite treatment is the histological confirmation of tumour-free resection margins. Incomplete resection with involved (R1) or indeterminate (Rx) margins is considered a strong risk factor for residual disease and local recurrence. Therefore, international guidelines recommend additional surgery in case of R1/Rx resection, even in absence of high-risk factors for LNM. Endoscopic full-thickness resection (eFTR) is a relatively new technique that allows transmural resection of colorectal lesions. Local scar excision after prior R1/Rx resection of low-risk T1 CRC could offer an attractive minimal invasive strategy to achieve confirmation about radicality of the previous resection or a second attempt for radical resection of residual luminal cancer. However, oncologic safety has not been established and long-term data are lacking. Besides, surveillance varies widely and requires standardization. METHODS/DESIGN: In this nationwide, multicenter, prospective cohort study we aim to assess feasibility and oncological safety of completion eFTR following incomplete resection of low-risk T1 CRC. The primary endpoint is to assess the 2 and 5 year luminal local tumor recurrence rate. Secondary study endpoints are to assess feasibility, percentage of curative eFTR-resections, presence of scar tissue and/or complete scar excision at histopathology, safety of eFTR compared to surgery, 2 and 5 year nodal and/or distant tumor recurrence rate and 5-year disease-specific and overall-survival rate. DISCUSSION: Since the implementation of CRC screening programs, the diagnostic rate of T1 CRC is steadily increasing. A significant proportion is not recognized as cancer before endoscopic resection and is therefore resected through conventional techniques primarily reserved for benign polyps. As such, precise histological assessment is often hampered due to cauterization and fragmentation and frequently leads to treatment dilemmas. This first prospective trial will potentially demonstrate the effectiveness and oncological safety of completion eFTR for patients who have undergone a previous incomplete T1 CRC resection. Hereby, substantial surgical overtreatment may be avoided, leading to treatment optimization and organ preservation. Trial registration Nederlands Trial Register, NL 7879, 16 July 2019 ( https://trialregister.nl/trial/7879 ).

Surgical management of children with intractable functional constipation; experience of a single tertiary children's hospital.

BACKGROUND: Children with intractable functional constipation (FC) may eventually require surgery. However, guidelines regarding the surgical management of children with intractable FC are lacking. The aim of this study was to describe the surgical management of FC in children. METHODS: A retrospective chart review was performed of children with FC (according to the Rome III criteria) who underwent ileostomy, colostomy or (sub)total colectomy at a tertiary hospital. Treatment success was defined as no longer fulfilling the Rome III-FC-criteria or having a functional ostomy. In addition, a self-developed questionnaire was administered to parents by telephone to assess postsurgical satisfaction (yes-no question and rated on a scale of 1-10). KEY RESULTS: Thirty-seven patients (68% female) were included; median age at first surgery was 12 years (range 1.6-17.6). The initial surgical procedure consisted of ileostomy (n=21), colostomy (n=10), sigmoid resection (n=5) and subtotal colectomy (n=1). Success criteria were fulfilled by 85% of the patients. Postsurgical satisfaction of parents was 91% with a median postoperative satisfaction score of 8 (range 2-10), and 97% would opt for the same procedure(s) if necessary. Thirty patients (81%) experienced stoma problems, with 12 patients (32%) requiring stoma-revisions. Other complications occurred in 16 patients (43%). CONCLUSIONS & INFERENCES: Surgery can improve symptoms in children with intractable FC. Despite morbidity and complications, parental satisfaction is high. Prospective, high-quality research is necessary to develop guidelines for the diagnostic work-up and surgical management in children with intractable FC.