Objective: The DoubleCheck study aimed to introduce pre- and perioperative interventions minimizing exposure to modifiable risk factors and determine its effect on CAL. Summary Background Data: Colorectal anastomotic leakage (CAL) is a severe complication. In order to predict and prevent its occurrence, the LekCheck study identified intraoperative modifiable risk factors for CAL: anemia, hyperglycemia, hypothermia, incorrect timing of antibiotic prophylaxis, administration of vasopressors and epidural analgesia. Methods: This international open-labelled interventional study was performed between September 2021 and December 2023. An enhanced care bundle consisting of anemia correction, glucose measurement, attaining normothermia, antibiotics administration within 60 to 15 minutes preoperatively, refraining from vasopressors and epidural analgesia was introduced. Primary outcome was the occurrence of intraoperative risk factors just prior to the anastomosis creation. Secondary outcomes were CAL and mortality. Univariate and multivariate regression analysis were performed to establish the relationship between the enhanced care bundle, exposure to the six factors and CAL. Results: The historical LekCheck group consisted of 1572 patients versus 902 in the DoubleCheck. The LekCheck group had a mean of 1.84 risk factors versus 1.63 in DoubleCheck (P<0.001). In the DoubleCheck significantly less patients had ≥3 risk factors (P<0.001). CAL was significantly lower in the DoubleCheck group (8.6% vs. 6.2%, P=0.039). The reduction of CAL was associated with the enhanced care bundle in multivariate regression analysis (OR 1.521, 95% CI 1.01-2.29, P=0.045). The mortality rate did not differ significantly (1.3%, vs. 0.8%, P=0.237). Conclusions: The DoubleCheck study showed that optimization of modifiable risk factors reduced CAL in colorectal surgery.

Background: Colorectal anastomotic leakage (CAL) remains a severe complication after bowel surgery. Recent research has identified several modifiable perioperative CAL risk factors. The aim of this study is to implement an enhanced perioperative care protocol, to optimize the intraoperative condition of the patient and minimalize exposure to modifiable CAL risk factors. Secondly, this study will investigate whether implementation of this new protocol results in a decreased CAL rate. Methods: The DOUBLE CHECK study will be performed using an open-label, international, multicenter design in 11 participating hospitals. The aim is to include an intervention group of 943 adult patients that underwent a colorectal resection with creation of a primary anastomosis. The patients in the intervention group will be treated according to an enhanced perioperative care protocol focusing on optimizing the intraoperative condition of the patient by minimalizing exposure to the following perioperative factors: anemia, hyperglycemia, hypothermia, epidural anesthesia, vasopressor drug administration, and incorrect or lack of antibiotic prophylaxis. The control group will consist of 1562 historical patients that were treated with standard perioperative practice (LekCheck study cohort). The patient’s intraoperative condition defined by exposure to the six perioperative risk factors, compliance to the DOUBLE CHECK study protocol, 30-day and 90-day CAL and other postoperative complications, length of hospital-stay, and ICU stay, hospital readmission and 30-day mortality will be measured. Discussion: The strength of this study is that it is an implementation study of an enhanced perioperative practice protocol for patients that are scheduled for colorectal resection in combination with a comparative study. This protocol could be a tool for other hospitals that want to improve their perioperative care pathway.

BACKGROUND:Colorectal cancer (CRC) is among the most frequently diagnosed cancers. Approximately 20-30% of stage I-III CRC patients develop a recurrent tumour or metastases after curative surgical resection. Post-operative follow-up is indicated for the first five years after curative surgical resection. As intensified follow-up after curative surgical resection has shown no effect on survival, patient organisations and policy makers have advocated for a more patient-centred approach to follow-up. The objective of this study is to successfully implement patient-led, home-based follow-up (PHFU) in six hospitals in The Netherlands, with as ultimate aim to come to a recommendation for a patient-centred follow-up schedule for stage I-III CRC patients treated with surgical resection with curative intent.METHODS:This study is designed as a stepped-wedge cluster-randomised trial (SW-CRT) in six participating centres. During the trial, three centres will implement PHFU after six months; the other three centres will implement PHFU after 12 months of inclusion in the control group. Eligible patients are those with pT2-4N0M0 or pT1-4N1-2M0 CRC, who are 18 years or older and have been free of disease for 12 months after curative surgical resection. The studied intervention is PHFU, starting 12 months after curative resection. The in-hospital, standard-of-care follow-up currently implemented in the participating centres functions as the comparator. The proportion of patients who had contact with the hospital regarding CRC follow-up between 12-24 months after curative surgical resection is the primary endpoint of this study. Quality of life, fear of cancer recurrence, patient satisfaction, cost-effectiveness and survival are the secondary endpoints.DISCUSSION:The results of this study will provide evidence on whether nationwide implementation of PHFU for CRC in The Netherlands will be successful in reducing contact between patient and health care provider. Comparison of PROMs between in-hospital follow-up and PHFU will be provided. Moreover, the cost-effectiveness of PHFU will be assessed.TRIAL REGISTRATION:Dutch Trail Register (NTR): NL9266 (Registered on January 1st, 2021).

Abstract Background The sole presence of deep submucosal invasion is shown to be associated with a limited risk of lymph node metastasis. This justifies a local excision of suspected deep submucosal invasive colon carcinomas (T1 CCs) as a first step treatment strategy. Recently Colonoscopy-Assisted Laparoscopic Wedge Resection (CAL-WR) has been shown to be able to resect pT1 CRCs with a high R0 resection rate, but the long term outcomes are lacking. The aim of this study is to evaluate the safety, effectiveness and long-term oncological outcomes of CAL-WR as primary treatment for patients with suspected superficial and also deeply-invasive T1 CCs. Methods In this prospective multicenter clinical trial, patients with a macroscopic and/or histologically suspected T1 CCs will receive CAL-WR as primary treatment in order to prevent unnecessary major surgery for low-risk T1 CCs. To make a CAL-WR technically feasible, the tumor may not include > 50% of the circumference and has to be localized at least 25 cm proximal from the anus. Also, there should be sufficient distance to the ileocecal valve to place a linear stapler. Before inclusion, all eligible patients will be assessed by an expert panel to confirm suspicion of T1 CC, estimate invasion depth and subsequent advise which local resection techniques are possible for removal of the lesion. The primary outcome of this study is the proportion of patients with pT1 CC that is curatively treated with CAL-WR only and in whom thus organ-preservation could be achieved. Secondary outcomes are 1) CAL-WR’s technical success and R0 resection rate for T1 CC, 2) procedure-related morbidity and mortality, 3) 5-year overall and disease free survival, 4) 3-year metastasis free survival, 5) procedure-related costs and 6) impact on quality of life. A sample size of 143 patients was calculated. Discussion CAL-WR is a full-thickness local resection technique that could also be effective in removing pT1 colon cancer. With the lack of current endoscopic local resection techniques for > 15 mm pT1 CCs with deep submucosal invasion, CAL-WR could fill the gap between endoscopy and major oncologic surgery. The present study is the first to provide insight in the long-term oncological outcomes of CAL-WR. Trial registration CCMO register (ToetsingOnline), NL81497.075.22, protocol version 2.3 (October 2022).

OBJECTIVE:The aim of this study was to evaluate the safety and efficacy of a modified CAL-WR. SUMMARY BACKGROUND DATA:The use of segmental colectomy in patients with endoscopically unresectable colonic lesions results in significant morbidity and mortality. CAL-WR is an alternative procedure that may reduce morbidity. METHODS:This prospective multicenter study was performed in 13 Dutch hospitals between January 2017 and December 2019. Inclusion criteria were (1) colonic lesions inaccessible using current endoscopic resection techniques (judged by an expert panel), (2) non-lifting residual/recurrent adenomatous tissue after previous polypectomy or (3) an undetermined resection margin after endoscopic removal of a low-risk pathological T1 (pT1) colon carcinoma. Thirty-day morbidity, technical success rate and radicality were evaluated. RESULTS:Of the 118 patients included (56% male, mean age 66 years, standard deviation ± 8 years), 66 (56%) had complex lesions unsuitable for endoscopic removal, 34 (29%) had non-lifting residual/recurrent adenoma after previous polypectomy and 18 (15%) had uncertain resection margins after polypectomy of a pT1 colon carcinoma. CAL-WR was technically successful in 93% and R0 resection was achieved in 91% of patients. Minor complications (Clavien-Dindo i-ii) were noted in 7 patients (6%) and an additional oncologic segmental resection was performed in 12 cases (11%). Residual tissue at the scar was observed in 5% of patients during endoscopic follow-up. CONCLUSIONS:CAL-WR is an effective, organ-preserving approach that results in minor complications and circumvents the need for major surgery. CAL-WR, therefore, deserves consideration when endoscopic excision of circumscribed lesions is impossible or incomplete.

Background: Anastomotic leak (AL) is a serious complication following colorectal surgery. Atherosclerosis causes inadequate anastomotic perfusion and is suggested to be a risk factor for AL. The aim of this study was to investigate the association between mesenteric occlusive disease on preoperative computed tomography (CT) scan and AL after left-sided colon or rectal cancer surgery.

Anastomotic leak (AL) is a serious complication following colorectal surgery. Atherosclerosis causes inadequate anastomotic perfusion and is suggested to be a risk factor for AL. The aim of this study was to investigate the association of mesenteric occlusive disease on preoperative computed tomography (CT) scan with AL after left-sided colon or rectal cancer surgery. This was a retrospective, multicenter cohort study including 1273 patients that underwent left-sided or rectal cancer resection between 2009 and 2018 from three hospitals in the Netherlands. AL patients were 1:1 matched with non-leak patients and preoperative contrast-enhanced CT-scans were retrospectively analyzed for mesenteric atherosclerotic lesions. The main outcome measure was the presence of mesenteric occlusive disease on the preoperative CT-scan. Anastomotic leak developed in 6% of 1273 patients (N = 76). Low anterior resection and stage I–III disease were statistically significant associated with AL (p = 0.01, p = 0.04). No other statistically significant differences in patient characteristics between AL and non-leak patients were found. A clinically significant stenosis (≥ 70–100%) of the inferior mesenteric artery was statistically significant more frequent present in AL patients, compared to non-leak patients (p < 0.01). No statistically significant differences in the presence of mesenteric occlusive disease of the celiac artery and superior mesenteric artery between AL patients and non-leak patients were found. Mesenteric occlusive disease of the IMA on preoperative CT-scan is associated with AL after left-sided colon or rectal resection for cancer. Preoperative identification of high-risk patients with a preoperative CT-scan of the mesenteric vasculature might be useful to reduce the risk of AL.

AbstractObjectiveTo investigate the association between patients' preferred treatment and eventual treatment. Second, to compare patients with surgical treatment to watchful waiting in order to identify predictive factors for surgery.MethodsA single‐centre retrospective study was performed between December 2015 and August 2018. Patients (≥18 years) who used a patient decision aid (PDA) for gallstones or inguinal hernia were included. After their first surgical consultation, patients received access to an online PDA. The patients' preferred treatment after the PDA was compared with their choice of eventual treatment. Multivariable regression analyses were performed for predictive factors for surgery.ResultsIn total, 567 patients with gallstones and 585 patients with an inguinal hernia were included. Of the patients with gallstones, 121 (21%) preferred watchful waiting, 367 (65%) preferred surgery, and 79 (14%) were not sure. The patients' preferred treatment was performed in 85.9%. Frequent pain attacks (OR 2.1, 95% CI 1.1‐3.9, P = .020) and preference for surgery (OR 4.4, 95% CI 1.9‐10.1, P = .001) independently predicted surgery. Of the patients with an inguinal hernia, 77 (13.2%) preferred watchful waiting, 452 (78.8%) preferred surgery, and 56 (9.6%) were not sure. The patients' preferred treatment was performed in 86.0%. The preference for surgery (OR 5.2, 95% CI 2.5‐10.6, P < .001) independently predicted surgery and worry about complications predicted avoidance of surgery (OR 0.5, 95% CI 0.2‐1.0, P = .037).ConclusionThis study, reflecting current clinical care, shows that patients' preferred treatment after using a PDA matches their eventual treatment choice in 86% of patients with gallstones or an inguinal hernia. In these patients, symptoms and patients' preference for surgery independently predicts eventual choice of surgery.

For both gallbladder removal and inguinal hernia repair, it is important to include patients’ perspective in the decision-making process, as watchful waiting is an accepted alternative in selected patients. The aim of this study was to evaluate operation rates before and after implementation of decision aids (DAs) and to assess patient compliance with the use of DAs.