Patients' perspectives and the perceptions of healthcare providers in the treatment of early rectal cancer; a qualitative study.

BACKGROUND: Shared decision-making has become of increased importance in choosing the most suitable treatment strategy for early rectal cancer, however, clinical decision-making is still primarily based on physicians' perspectives. Balancing quality of life and oncological outcomes is difficult, and guidance on patients' involvement in this subject in early rectal cancer is limited. Therefore, this study aimed to explore preferences and priorities of patients as well as physicians' perspectives in treatment for early rectal cancer. METHODS: In this qualitative study, semi-structured interviews were performed with early rectal cancer patients (n = 10) and healthcare providers (n = 10). Participants were asked which factors influenced their preferences and how important these factors were. Thematic analyses were performed. In addition, participants were asked to rank the discussed factors according to importance to gain additional insights. RESULTS: Patients addressed the following relevant factors: the risk of an ostomy, risk of poor bowel function and treatment related complications. Healthcare providers emphasized oncological outcomes as tumour recurrence, risk of an ostomy and poor bowel function. Patients perceived absolute risks of adverse outcome to be lower than healthcare providers and were quite willing undergo organ preservation to achieve a better prospect of quality of life. CONCLUSION: Patients' preferences in treatment of early rectal cancer vary between patients and frequently differ from assumptions of preferences by healthcare providers. To optimize future shared decision-making, healthcare providers should be aware of these differences and should invite patients to explore and address their priorities more explicitly during consultation. Factors deemed important by both physicians and patients should be expressed during consultation to decide on a tailored treatment strategy.

Video-based tools for surgical quality assessment of technical skills in laparoscopic procedures: a systematic review.

BACKGROUND: Quality of surgery has substantial impact on both short- and long-term clinical outcomes. This stresses the need for objective surgical quality assessment (SQA) for education, clinical practice and research purposes. The aim of this systematic review was to provide a comprehensive overview of all video-based objective SQA tools in laparoscopic procedures and their validity to objectively assess surgical performance. METHODS: PubMed, Embase.com and Web of Science were systematically searched by two reviewers to identify all studies focusing on video-based SQA tools of technical skills in laparoscopic surgery performed in a clinical setting. Evidence on validity was evaluated using a modified validation scoring system. RESULTS: Fifty-five studies with a total of 41 video-based SQA tools were identified. These tools were used in 9 different fields of laparoscopic surgery and were divided into 4 categories: the global assessment scale (GAS), the error-based assessment scale (EBAS), the procedure-specific assessment tool (PSAT) and artificial intelligence (AI). The number of studies focusing on these four categories were 21, 6, 31 and 3, respectively. Twelve studies validated the SQA tool with clinical outcomes. In 11 of those studies, a positive association between surgical quality and clinical outcomes was found. CONCLUSION: This systematic review included a total of 41 unique video-based SQA tools to assess surgical technical skills in various domains of laparoscopic surgery. This study suggests that validated SQA tools enable objective assessment of surgical performance with relevance for clinical outcomes, which can be used for training, research and quality improvement programs.

The learning curve of transanal total mesorectal excision for rectal cancer is associated with local recurrence: results from a multicentre external audit.

AIM: Transanal total mesorectal excision (TaTME) has been suggested as a potential solution for the resection of challenging mid and low rectal cancer. This relatively complex procedure has been implemented in many centres over the last years, despite the absence of long-term safety data. Recently, concern has arisen because of an increase in local recurrence in the implementation phase. The aim of this study was to assess the correlation between accumulated experience and local recurrences. METHOD: An independent clinical researcher performed an external audit of consecutive series of all TaTME procedures in six centres in the Netherlands. Kaplan-Meier estimated local recurrence rates were calculated and multivariate Cox proportional hazards regression analysis performed to assess risk factors for local recurrence. Primary outcome was the local recurrence rate in the initial implementation (cases 1-10), continued adoption (cases 11-40) and prolonged experience (case 41 onward). RESULTS: Six hundred and twenty-four consecutive patients underwent TaTME for rectal cancer with a median follow-up of 27 months (range 1-82 months). The estimated 2- and 3-year local recurrence rates were 4.6% and 6.6%, respectively. Cox proportional hazards regression revealed procedural experience to be an independent factor in multivariate analysis next to advanced stage (ycMRF+, pT3-4, pN+) and pelvic sepsis. Corrected analysis projected the 3-year local recurrence rates to be 9.7%, 3.3% and 3.5% for the implementation, continued adoption and prolonged experience cohorts, respectively. CONCLUSION: This multicentre study shows a high local recurrence rate (12.5%) after implementation of TaTME which lowers to an acceptable rate (3.4%) when experience increases. Therefore, intensified proctoring and further precautions must be implemented to reduce the unacceptably high risk of local recurrence at units starting this technique.

Neoadjuvant (chemo)radiotherapy and Lateral Node Dissection: Is It Mutually Exclusive?

The importance of total mesorectal excision (TME) has been the global standard of care in patients with rectal cancer. However, there is no universal strategy for lateral lymph nodes (LLN). The treatment of the lateral compartment remains controversial and has gone to the opposite directions between Eastern and Western countries in the past decades. In the East, mainly Japan, surgeons consider LLN metastases as regional disease and have performed TME with lateral lymph node dissection (LLND) without neoadjuvant (chemo)radiotherapy ([C]RT) in patients with clinical Stage II/III rectal cancer below the peritoneal reflection. In the West, neoadjuvant radiotherapy or has been the standard, and surgeons do not perform LLND assuming the (C)RT can sterilize most lateral lymph node metastasis (LLNM). Recent evidences show that lateral nodes are the major cause of local recurrence after (C)RT plus TME, and LLND reduces local recurrence particularly from the lateral compartment. Probably a combination of the two strategies, that is, neoadjuvant (C)RT plus LLND, would be needed to improve outcomes in patients with lateral nodal disease.

Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

Long-term oncological results after transanal total mesorectal excision for rectal carcinoma.

BACKGROUND: Transanal total mesorectal excision (TaTME) for mid and low rectal cancer has been shown to improve short-term outcomes, mostly due to lower conversion rates and with improved quality of the specimen. However, robust long-term oncological data supporting the encouraging clinical and pathological outcomes are lacking. METHODS: All consecutive patients undergoing TaTME with curative intent for mid or low rectal cancer in two referral centers in The Netherlands between January 2012 and April 2016 with a complete and minimum follow-up of 36 months were included. The primary outcome was local recurrence rate. Secondary outcomes were disease-free survival, overall survival and development of metastasis. RESULTS: There were 159 consecutive patients. Their mean age was 66.9 (10.2) years and 66.7% of all patients were men. Pathological analysis showed a complete mesorectum in 139 patients (87.4%), nearly complete in 16 (10.1%) and an incomplete mesorectum in 4 (2.5%). There was involvement of the CRM (< 1 mm) in one patient (0.6%) and no patients had involvement of the distal margin (< 5 mm). Final postoperative staging after neoadjuvant therapy was stage 0 in 11 patients (6.9%), stage I in 73 (45.9%), stage II in 31 (19.5%), stage III in 37 (23.3%) and stage IV in 7 (4.4%). The 3-year local recurrence rate was 2.0% and the 5-year local recurrence rate was 4.0%. Median time to local recurrence was 19.2 months. Distant metastases were found in 22 (13.8%) patients and were diagnosed after a median of 6.9 months (range 1.1-50.4) months. Disease-free survival was 92% at 3 years and 81% at 5 years. Overall survival was 83.6% at 3 years and 77.3% at 5 years. CONCLUSIONS: The long-term follow-up of the current cohort confirms the oncological safety and feasibility of TaTME in two high volume referral centers for rectal carcinoma. However, further robust and audited data must confirm current findings before widespread implementation of TaTME.

Intracorporeal versus extracorporeal anastomosis in right hemicolectomy: a systematic review and meta-analysis.

BACKGROUND: Laparoscopic right hemicolectomy for colon cancer is associated with substantial morbidity despite the introduction of enhanced recovery protocols and laparoscopic surgery. Laparoscopic right hemicolectomy with an intracorporeal anastomosis (IA) is less invasive than laparoscopic assisted hemicolectomy, possibly leading to further decrease in post-operative morbidity and faster recovery. The current standard technique includes an extracorporeal anastomosis with mobilization of the colon, mesenteric traction and a extraction wound located in the mid/upper abdomen with relative more post-operative morbidity compared to extraction wounds located in the lower abdomen. METHODS: A systematic review of PubMed and Embase databases was performed on studies comparing the intracorporeal versus the extracorporeal performed anastomosis in laparoscopic right hemicolectomy. Primary outcomes were mortality, short-term morbidity and length of stay. For quality assessment, the MINORS checklist was used. Meta-analysis was performed using a random-effects model, and a subgroup analysis was performed for data regarding short-term morbidity and length of stay in studies published in 2012≥. RESULTS: A total of 2692 papers were identified, 12 non-randomized comparative studies were included in the analysis with a total number of 1492 patients. No significant change in mortality was found (OR 0.36, 95 % CI 0.09-1.46; I 2 = 0 %). Short-term morbidity decreased significantly in favour of IA (OR 0.68, 95 % CI 0.49-0.93; I 2 = 20 %). Length of stay was decreased, but with serious risk of heterogeneity (MD -0.77 days, 95 % CI -1.46 to -0.07; I 2 = 81 %). Subgroup analysis for papers published in 2012≥ resulted in an even larger decrease in short-term morbidity (OR 0.65, 95 % CI 0.50-0.85; I 2 = 0 %) and a significant decrease in length of stay with low risk of heterogeneity (MD -0.77 days, 95 % CI -1.17 to -0.37; I 2 = 4 %). CONCLUSION: Intracorporeal anastomosis in laparoscopic right hemicolectomy is associated with reduced short-term morbidity and decreased length of hospital stay suggesting faster recovery as shown in this meta-analysis.

Comparison of transanal total mesorectal excision (TaTME) versus laparoscopic TME for rectal cancer: A case matched study.

BACKGROUND: Transanal total mesorectal excision (TaTME) has been developed to improve the quality of laparoscopic TME for patients with rectal cancer. Recently, international concern on TaTME was raised by a national cohort study showing an increased rate of local recurrences. This study aimed to compare clinicopathological and mid-term oncological outcomes of TaTME versus laparoscopic TME (LaTME) for mid and low rectal cancer of a high volume center. METHODS: From August 2014 to October 2019, patients with mid or low rectal cancer who received TaTME procedure were identified. The cases were matched with patients treated with LaTME. Data were retrospectively collected including operative details, postoperative morbidity, pathologic results, and oncologic outcomes. Primary endpoint was the local recurrence (LR) rate. RESULTS: Propensity score matching yielded 70 patients in each of the groups. There were no statistically significant differences between the 2 groups in terms of postoperative complications, conversion rate to open surgery and circumferential resection margin. Local recurrence occurred in 2 patients (2.9%) in the transanal group, whereas 1 patient developed a local recurrence in the laparoscopic group (1.4%)(p = 0.559). Kaplan-Meier survival analysis showed a 2 year Local recurrence rate 1.5% VS 1.6%(p = 0.934), DFS 88.0% VS 87.7%, OS 94.0% vs 100% for transanal and laparoscopic group, respectively. CONCLUSIONS: In a high volume center the transanal total mesorectal procedure is feasible, and appears to be safe alternative to laparoscopic surgery. Oncological outcomes were acceptable and no increased multi or unifocal local recurrence rate was found.

The safety and efficacy of improvised tourniquets in life-threatening hemorrhage: a systematic review.

OBJECTIVE: The increased incidence of mass casualty incident (MCI) with penetrating injuries in the civilian setting creates a call for implementing devices, such as a tourniquet (TQ), in civilian first aid. Bystanders could act as immediate responders after an MCI in order to prevent a victim from exsanguination using direct pressure or commercial tourniquets (C-TQ). Reports have shown that immediate access to C-TQs was not available and bystanders used objects available at the trauma scene to make an improvised tourniquet (I-TQ). The aim of this systematic review of literature was to summarize the existing literature on designs, efficacy and safety of I-TQs. METHODS: A systematic review of the literature was performed. Bibliographic databases PubMed, EMBASE.com and Cochrane Library were searched. All types of original studies about I-TQ's were included. Review studies, exempts from textbooks or studies with TQs applied during elective surgeries were excluded. RESULTS: Twenty studies were included. In both simulated experiments and real-life situations, I-TQs outperformed commercial TQs (C-TQ) regarding success rate. Of the I-TQs, the band and windlass design performed most consistently. Although lacking any statistical analysis, there was no reported difference in adverse events between I-TQs and C-TQs. CONCLUSION: The use of- and training in I-TQ by civilian immediate responders is not recommended because of limited efficacy and safety concerns; direct pressure is a viable alternative. However, I-TQs may save lives when applied correctly with proper objects; therefore, future studies regarding the best design and training in application of effective and safe I-TQs should be encouraged.

Three-Year Nationwide Experience with Transanal Total Mesorectal Excision for Rectal Cancer in the Netherlands: A Propensity Score-Matched Comparison with Conventional Laparoscopic Total Mesorectal Excision.

BACKGROUND: Transanal total mesorectal excision (TaTME) is a relatively new and demanding technique for rectal cancer treatment. Results from national datasets are absent and comparative data with laparoscopic TME (lapTME) are scarce. Therefore, this study aimed to evaluate the initial TaTME experience in the Netherlands, by comparing outcomes with conventional lapTME. STUDY DESIGN: Patients with rectal cancer who underwent curative TaTME or lapTME were selected from the nationwide and mandatory Dutch ColoRectal Audit (DCRA), between January 2015 and December 2017. Primary outcome was circumferential resection margin (CRM) involvement. Secondary outcomes included operative details and short-term (<30 days) clinical course. Propensity score matching was performed for 7 factors. RESULTS: There were 3,777 patients included for analysis (TaTME, n = 416, lapTME, n = 3361). Transanal TME was performed in 38 hospitals and lapTME in 90 hospitals. Before matching, the patient category within the TaTME group was technically more challenging in terms of tumor height and preoperative threatened margins. After 1:1 matching, 396 patients were included in each group, with comparable baseline characteristics. Circumferential resection margin involvement was 4.3% after TaTME and 4.0% after lapTME (p = 1.000). Conversion rate was significantly lower in TaTME (1.5% vs 8.6%, p < 0.001). Anastomotic leak rate was not significantly different (16.5% vs 12.2%, p = 0.116). Other postoperative outcomes were also comparable between the groups. Significant independent risk factors for CRM involvement in TaTME were preoperative threatened margin on MRI (odds ratio [OR] 5.48, 95% CI 1.33 to 22.54) and conversion (OR 30.12, 95% CI 3.70 to 245.20). CONCLUSIONS: This first nationwide study shows early experience with adoption of TaTME in the Netherlands. Considering that current data represent initial TaTME experience, acceptable short-term outcomes were demonstrated when compared with the well-established lapTME.

[Application of flexible transanal port for excision of rectal tumours]. / Toepassing flexibele toegangspoort voor excisie rectumtumoren.

In 2010 the first report of the application of the flexible transanal port ('operation platform') for the excision of rectal tumours was published. Due to the enhanced vision it provides, adenomas and small malignant rectal tumours can be radically resected with significantly fewer recurrences than with endoscopic mucosal resection or transanal excisions done without this platform. The application of this platform is cheaper and more intuitive than transanal endoscopic microsurgery, while the quality of the local resection, the risk of postoperative complications and the functional and oncological outcomes all appear to be comparable. This is the reason that this flexible platform is now in use in most Dutch hospitals. The flexible port has led to an increase in rectum-sparing treatment for low-risk T1 rectal carcinoma. Nowadays, this platform is also used for the transanal approach during radical rectal surgery for high-risk rectal carcinomas and for rectal operations in patients with benign conditions in the pelvis minor such as severe endometriosis or Crohn's disease.