Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: the CLEAN study.

INTRODUCTION: Non-healing of anastomotic leakage can be observed in up to 50% after total mesorectal excision for rectal cancer. This study investigates the efficacy of early transanal closure of anastomotic leakage after pre-treatment with the Endosponge® therapy. METHODS: In this prospective, multicentre, feasibility study, transanal suturing of the anastomotic defect was performed after vacuum-assisted cleaning of the presacral cavity. Primary outcome was the proportion of patients with a healed anastomosis at 6 months after transanal closure. Secondary, healing at last follow-up, continuity, direct medical costs, functionality and quality of life were analysed. RESULTS: Between July 2013 and July 2015, 30 rectal cancer patients with a leaking low colorectal anastomosis were included, of whom 22 underwent neoadjuvant radiotherapy. Median follow-up was 14 (7-29) months. At 6 months, the anastomosis had healed in 16 (53%) patients. At last follow-up, anastomotic integrity was found in 21 (70%) and continuity was restored in 20 (67%) patients. Non-healing at 12 months was observed in 10/29 (34%) patients overall, and in 3/14 (21%) when therapy started within three weeks following the index operation. Major LARS was reported in 12/15 (80%) patients. The direct medical costs were €8933 (95% CI 7268-10,707) per patient. CONCLUSION: Vacuum-assisted early transanal closure of a leaking anastomosis after total mesorectal excision with 73% preoperative radiotherapy showed that acceptable anastomotic healing rates and stoma reversal rates can be achieved. Early diagnosis and start of treatment seems crucial.

The effects of physical prehabilitation in elderly patients undergoing colorectal surgery: a systematic review.

AIM: Prehabilitation, defined as enhancement of the preoperative condition of a patient, is a possible strategy for improving postoperative outcome. Lack of muscle strength and poor physical condition, increasingly prevalent in older patients, are risk factors for postoperative complications. Eighty-five per cent of patients with colorectal cancer are aged over 60 years. Since surgery is the cornerstone of their treatment, this review systemically examined the literature on the effect of physical prehabilitation in older patients undergoing colorectal surgery. METHOD: Trials and case-control studies investigating the effect of physical prehabilitation in patients over 60 years undergoing colorectal surgery were retrieved from MEDLINE, EMBASE, CINAHL and the Cochrane library. Patient characteristics, the type of intervention and outcome measurements were recorded. The risk of bias and heterogeneity was assessed. RESULTS: Five studies including 353 patients were identified. They were small, containing an average of 77 patients and were of moderate methodological quality. Compliance rates of the prehabilitation programme varied from 16 to 97%. None of the studies could identify a significant reduction of postoperative complications or length of hospital stay. Four studies showed physical improvement (walking distance, respiratory endurance) in the prehabilitation group. Clinical heterogeneity precluded a meta-analysis. CONCLUSION: Prehabilitation is a possible means of enhancing the physical condition of patients preoperatively. The quality of studies in older patients undergoing colorectal surgery is poor, despite the increase in elderly people with colorectal cancer. Defining specific patient groups at risk and standardizing the outcome are essential for improving the results of treatment.

Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.

BACKGROUND: At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer. METHODS/DESIGN: In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland. DISCUSSION: This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity. TRIAL REGISTRATION: ClincalTrials.gov: NCT02243735 .

Lymph node size as a predictor of lymphatic staging in colonic cancer.

BACKGROUND: In colonic cancer, the number of harvested lymph nodes is associated with prognosis. The aim of this study was to determine the contribution of small lymph nodes to pathological staging, and to analyse the hypothesis that node size is a confounder in the relationship between prognosis and nodal harvest. METHODS: Nodal harvest and size were analysed in patients who underwent elective surgery for colonic cancer. Visible and palpable nodes were harvested without fat clearance techniques, and conventional histology was performed. RESULTS: Metastases were found in 99 of 2043 measured lymph nodes in 150 patients. Lymph nodes smaller than 3 mm were positive in 8.0 per cent of patients (12 of 150), but were the sole reason for upstaging in only 1.3 per cent (2 of 150). No metastases were found among 95 nodes of 1 mm or less. Metastatic nodes were larger than those without metastasis (median (i.q.r.) 5.0 (3.2-7.0) versus 3.8 (2.4-5.2) mm; P < 0·001), but a receiver operating characteristic (ROC) curve did not identify a relevant cut-off point to predict metastatic involvement. A hazard ratio of 0.71 (95 per cent confidence interval 0.50 to 1.01) was suggestive of an association between disease recurrence and increased node size, although not significant (P = 0.056). In patients with N0 disease, there was a correlation between node size and harvest (Pearson's correlation 0.317, P = 0.002), and a nodal yield of at least 12 was associated with a larger median node size (4.3 (3.3-5.0) versus 3.4 (2.7-4.0) mm; P = 0.015). CONCLUSION: The contribution of lymph nodes smaller than 3 mm to nodal staging is limited. Increased node size is associated with increased nodal yield, and could be a confounder in the relationship between prognosis and nodal harvest in patients with N0 disease.

Bridge-to-surgery stent placement versus emergency surgery for acute malignant colonic obstruction.

BACKGROUND: Endoscopic self-expanding metal stent (SEMS) placement as a bridge to surgery is an option for acute malignant colonic obstruction. There is ongoing debate regarding the superiority and oncological safety of SEMS placement compared with emergency surgery. This retrospective study aimed to compare outcomes of these treatment approaches. METHODS: Patients were identified from cohorts treated between 2005 and 2012 in two teaching hospitals, of which one used emergency surgery only in patients with large bowel obstruction, whereas the other attempted SEMS placement. Only patients treated with curative intent were included. RESULTS: The study included 59 patients in whom SEMS placement was attempted and 51 who underwent surgery alone. The successful primary anastomosis rate was higher in the SEMS group than in the surgery-alone group among patients with left-sided obstruction (30 of 43 versus 10 of 34 respectively; P = 0.001), whereas stoma formation was less common (11 of 43 versus 23 of 34; P < 0.001). Such differences were not apparent in patients with right-sided obstruction. Secondary stoma rates were comparable between treatment approaches (left-sided: 11 of 43 versus 13 of 34, P = 0.322; right-sided: 1 of 16 versus 1 of 17, P = 1.000). There were no significant differences in morbidity, mortality, recurrence or survival. CONCLUSION: Endoscopic SEMS placement increased the primary anastomosis rate in patients with left-sided large bowel obstruction.

Implications of sentinel lymph node mapping on nodal staging and prognosis in colorectal cancer.

AIM: Sentinel lymph node (SN) mapping for staging in colorectal cancer remains controversial and needs to be validated before it can be implemented in daily practice. We prospectively assessed the effect of SN mapping on nodal staging and its implication on survival in patients with colorectal cancer. METHOD: Between November 2005 and July 2009, 331 patients underwent a resection for colorectal cancer. In 189 patients (group A) an ex-vivo SN procedure was performed with immunohistochemical analysis of the SN. Tumour cell deposits between 0.2 mm and 2.0 mm were referred to as micrometastases (pN1mi+). The remaining patients (n = 142, group B) had standard nodal staging. Multivariate Cox regression analysis was performed to identify prognostic factors for disease recurrence. RESULTS: The average number of harvested lymph nodes was higher in group A than in group B (15.5 ± 7.3 vs 12.1 ± 5.2, P < 0.0001). After conventional staging, 81 (43%) patients of group A were judged to have nodal metastasis. This increased to 89 (47%) patients when immunohistochemically detected micrometastases were included. In group B, 50 (35%) patients had nodal metastasis. During follow up, a lower recurrence rate was seen in N0 patients after SN mapping compared with the conventional staging group (4%vs 15.2%, P = 0.04). The SN procedure (hazard ratio = 4.1) was an independent predictor of disease recurrence. CONCLUSION: The SN procedure results in a more accurate staging of patients with colorectal cancer. This is reflected by a better prognosis of N0 patients after SN mapping.

Outcomes of surgical treatment of non-metastatic gastric cancer in patients aged 70 and older: A systematic review and meta-analysis.

The optimal surgical treatment strategy for gastric cancer in older patients needs to be carefully evaluated due to increased vulnerability of older patients. We performed a database search for randomized controlled trials (RCTs) and cohort studies that included patients ≥70 years with potentially resectable stage I-III gastric cancer. Postoperative and survival outcomes were compared between groups undergoing 1) gastrectomy vs conservative treatment (best supportive care or non-operative treatment), 2) minimally invasive (MIG) vs open gastrectomy (OG), or 3) extended vs limited lymphadenectomy. When possible, results were pooled using risk ratios (RR). Thirty-one studies were included. Six retrospective studies compared overall survival (OS) between gastrectomy (N = 2332) and conservative treatment (N = 246). Longer OS was reported in the gastrectomy group in all studies, but study quality was low and meta-analysis was not feasible. Eighteen cohort studies compared MIG (N = 3626) and OG (N = 5193). MIG was associated with fewer complications (pooled RR 0.68, 95% confidence interval 0.54-0.84). OS was not different between the groups. Two RCTs and five cohort studies compared outcomes between extended (N = 709) and limited lymphadenectomy (N = 1323). Complication rates were comparable between the groups. Two cohort studies found longer OS or cancer-specific survival after extended lymphadenectomy. No quality of life (QoL) or functional outcomes were reported. In older patients with gastric cancer, there is low-quality evidence for better OS after gastrectomy vs conservative treatment. Compared to OG, MIG was associated with less postoperative morbidity. The evidence to support extended lymphadenectomy is limited. QoL and functional outcomes should be addressed in future studies.

The persisting presacral sinus after anastomotic leakage following anterior resection or restorative proctocolectomy.

AIM: Despite improvements in anastomotic technique, anastomotic leakage is frequently encountered following anterior resection. This can eventually evolve into a presacral sinus. This study assessed the incidence, the natural course and the outcome of persisting presacral sinus. METHOD: Patients who underwent low anterior resection (LAR) for cancer or restorative proctocolectomy (RPC) for ulcerative colitis or familial polyposis were eligible. Patients with anastomotic leakage or a presacral abscess were included. Outcome parameters included a persistent presacral sinus, or its closure and average time to closure and the stoma closure rate. RESULTS: Twenty-five patients were identified with a sinus after LAR (n = 20) or RPC (n = 5). A persistent sinus was present in nine (1%) of 834 patients after LAR and two (0.9%) of 229 patients after RPC. Definitive resolution of the sinus occurred in 12 (52%) of 23 assessable patients. This was achieved at a median of 340 days (range 23-731 days). At final follow-up, nine of the 23 patients had permanent faecal diversion because of recurrent abscess or persistent sinus formation, seven after LAR and two after RPC. CONCLUSION: A significant proportion of patients with anastomotic leakage after rectal surgery develop a chronic sinus, of which only half heal over time. Persisting sinus is the main reason for a permanent stoma.

Decreased incidence of isolated tumor cells in lymph nodes after laparoscopic resection for colorectal cancer.

BACKGROUND: Laparoscopic surgery has potential for less tumor cell spread because of the no-touch technique. We assessed the effect of the surgical approach (open versus no-touch laparoscopic) on the presence of tumor cells in sentinel lymph nodes (SN) of patients with stage I and II colorectal cancer. METHODS: A single-center consecutive prospective series of patients operated on for colorectal cancer was analyzed. After conventional hematoxylin and eosin (H&E) staining, 107 patients without lymphatic metastases were included; 59 patients had open surgery, and 48 patients underwent laparoscopic resection. Patients in the laparoscopic group underwent a no-touch medial to lateral approach, whereas the conventional lateral to medial approach was applied in open surgery. A SN procedure was performed in all patients. The SNs were immunohistochemically analyzed for presence of occult tumor cells (OTC). According to the American Joint Committee on Cancer (AJCC) these tumor cells were divided into micrometastases (0.2-2 mm) or isolated tumor cells (ITC, < 0.2 mm). RESULTS: In ten patients micrometastases were found, equally distributed between the two groups. However, ITC were more often found after open surgery (18 versus 5 patients, p = 0.03). Presence of OTC was related to depth of tumor invasion and tumor diameter > 3.5 cm. Logistic regression analysis identified lymphovascular invasion as a predictor for micrometastases [odds ratio (OR) 18.4], whereas open resection was predictive for presence of ITC (OR 3.3). CONCLUSIONS: No-touch medial to lateral laparoscopic surgery results in less isolated tumor cells in lymph nodes compared with open lateral to medial surgery in patients with stage I and II colorectal cancer.