Surgical quality assessment for the prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for nonmetastatic right colon cancer (PIONEER study).

BACKGROUND: The modified complete mesocolic excision (mCME) procedure for right-sided colon cancer is a tailored approach based on the original complete mesocolic excision (CME) methodology. Limited studies evaluated the safety and feasibility of laparoscopic mCME using objective surgical quality assessments in patients with right colon cancer. The objectives of the PIONEER study were to evaluate oncologic outcomes after laparoscopic mCME and to identify optimal clinically relevant endpoints and values for standardizing laparoscopic right colon cancer surgery based on short-term outcomes of procedures performed by expert laparoscopic surgeons. MATERIALS AND METHODS: This is an ongoing prospective, multi-institutional, single-arm study conducted at five tertiary colorectal cancer centers in South Korea. Study registrants included 250 patients scheduled for laparoscopic mCME with right-sided colon adenocarcinoma (from the appendix to the proximal half of the transverse colon). The primary endpoint was 3-year disease-free survival. Secondary outcomes included 3-year overall survival, incidence of morbidity in the first 4 weeks postoperatively, completeness of mCME, central radicality, and distribution of metastatic lymph nodes. Survival data will be available after the final follow-up date (June 2024). RESULTS: The postoperative complication rate was 12.9%, with a major complication rate of 2.7%. In 87% of patients, central radicality was achieved with dissection at or beyond the level of complete exposure of the superior mesenteric vein. Mesocolic plane resection with an intact mesocolon was achieved in 75.9% of patients, as assessed through photographs. Metastatic lymph node distribution varied by tumor location and extent. Seven optimal clinically relevant endpoints and values were identified based on the analysis of complications in low-risk patients. CONCLUSIONS: Laparoscopic mCME for right-sided colon cancer produced favorable short-term postoperative outcomes. The identified optimal clinically relevant endpoints and values can serve as a reference for evaluating surgical performance of this procedure.

Novel graded prognostic assessment for colorectal cancer patients with brain metastases.

PURPOSE: It is important to take into account potential prognostic factors to select patients with brain metastasis from colorectal cancer (CRC) who will benefit from active neurosurgical treatment. Therefore, we experimentally investigated our single institutional data to develop a novel CRC-specific graded prognostic assessment (GPA) and to help clinicians determine the optimal management. METHODS AND MATERIALS: We retrospectively reviewed the records of 107 patients with brain metastases from CRC who received any kind of treatment in our hospital and had sufficient clinical information. RESULTS: The median overall survival was 5.2 months, and the 1- and 2-year overall survival rates were 23.7 and 6.6%, respectively. Multivariate analysis revealed that the number of brain metastases ≥ 6, presence of neurologic symptoms, and elevated serum carcinoembryonic antigen (≥ 30 ng/ml) were the independent prognostic factors for poor overall survival, while performance status was not. Based on this, we developed the CRC-specific GPA index and stratified patients into three categories. The median overall survival for patients with GPA scores of 0-0.5, 1.0-1.5, and 2.0-2.5 was 2.3, 4.3, and 12.7 months, respectively (p < 0.001). Surgery or stereotactic radiosurgery ± whole-brain radiotherapy showed a better survival than palliative whole-brain radiotherapy alone in patients with high GPA scores. CONCLUSIONS: We developed a novel CRC-specific GPA index, which could help physicians to stratify patients with brain metastases. Further efforts are needed to validate and improve this index.

Development and validation of the smart management strategy for health assessment tool-short form (SAT-SF) in cancer survivors.

PURPOSE: The aim of this study was to develop and validate a short form (SF) of the Smart Management Strategy for Health Assessment Tool (SAT) for cancer patients. METHODS: Data for item reduction were derived from cancer patient data (n = 300) previously used to develop the original SAT. We used regression methods to select and score the new SAT-SF. To assess the instrument's reliability and validity, we recruited another 354 cancer patients from the same hospitals who were older than 18 years and accustomed to using the web. All results were compared with that of the long-form SAT (original SAT). RESULTS: The SAT-SF used is the shorter version, a 30-item (from the original 91-item) instrument, to measure cancer patient's health. The 30-item SAT-SF explained 97.7% of total variance of the full 91-item long-form SAT. All SAT-SF subscales demonstrated a high reliability with good internal consistency compared with the original SAT. The total short-form scores of the three SAT sets (SAT-Core, SAT-Preparation, SAT-Implementation) differentiated participant groups according to their stage of goal implementation and percentage of actions taken in the 10 Rules for Highly Effective Health Behavior. We found acceptable correlations between the three SAT-SF sets and the additional assessment tools compared with the original SAT. CONCLUSIONS: The 30-item SAT-SF had a satisfactory internal consistency and validity for cancer patients with minimal loss of information compared with the original SAT.

Patient-reported assessment of self-management strategies of health in cancer patients: development and validation of the Smart Management Strategy for Health Assessment Tool (SAT).

OBJECTIVE: The objective of this study was to evaluate the psychometric properties of the Smart Management Strategy for Health Assessment Tool (SAT), which we developed to enable cancer patients to assess their self-management (SM) strategies of health by themselves. PATIENTS AND METHODS: The development of the questionnaire included four phases: item generation, construction, pilot testing, and field testing. To assess the instrument's sensitivity and validity, we recruited 300 cancer patients from three Korean hospitals who were 18 or more years old and accustomed to using the Internet or email. Using the appropriate and priority criteria for pilot and field testing, we tightened the content and constructed the first version of the SAT. RESULTS: We developed the core strategies with 28 items, preparation strategies with 30 items, and implementation strategies with 33 items. Factor analysis of data from 300 patients resulted in core strategies with four factors, preparation strategies with five factors, and implementation strategies with six factors. All the SAT subscales demonstrated a high reliability with good internal consistency. The total scores of the three SAT sets differentiated participant groups well according to their stage of goal implementation and proportions of action of the 10 Rules for Highly Effective Health Behavior. Each factor of the three SAT sets correlated positively with the scores for additional assessment tool. CONCLUSION: The SAT is a three-set, 16-factor, 91-item tool that assesses the SM strategies of health that patients use to overcome a crisis. Patients can use the SAT to assess their SM strategies of health and obtain feedback from clinicians in the practice setting.

Cost-comparison of laparoscopic and open surgery for mid or low rectal cancer after preoperative chemoradiotherapy: data from a randomized controlled trial.

BACKGROUND: The purpose of the present study was to compare the direct costs of laparoscopic surgery (LS) and open surgery (OS) in the treatment of mid or low rectal cancer after preoperative chemoradiotherapy in patients in Korea. METHODS AND RESULTS: The records of 130 LS patients and 125 OS patients were reviewed. Hospital stay after surgery and overall complication rates within three months of surgery were not significantly different. The LS group had significantly higher median costs than the OS group ($7,467.30 vs. $5,667.00; P < 0.001). The median hospital costs during hospitalization for surgery were higher in the LS group ($7,436.60 vs. $5,626.60; P < 0.001), but hospital costs for management of early postoperative complications were similar. The higher direct costs of LS were mainly due to the more expensive consumables and equipment needed for LS. CONCLUSIONS: Further study is needed to determine whether the higher direct costs of LS for rectal cancer are balanced by advantages of LS over OS, such as better short-term outcomes and cosmetic effect.

Learning curve of assistants in laparoscopic colorectal surgery: overcoming mirror imaging.

BACKGROUND: Laparoscopic colorectal resection is widely used because of its safety and effectiveness compared with conventional surgery; however, surgical assistants find it difficult to perform this surgery in mirror image. This study aimed to evaluate assistants' learning curves in laparoscopic colorectal surgery. METHODS: The subjects were three fellows who began their surgical fellowship training at the Center for Colorectal Cancer of the National Cancer Center, Korea, during 2008. We analyzed the data from 145 laparoscopic colorectal surgeries in which these assistants participated. A learning curve was generated for each assistant using the moving average method to assess the execution time and the error rate for grasping tissue. RESULTS: Assistants A, B, and C participated in 50, 45, and 50 laparoscopic colorectal surgeries, respectively. Learning curves indicated that the execution time reached a steady state after 38 cases for Assistant A, 29 cases for Assistant B, and 24 cases for Assistant C. Based on a decline in the error rate, the steady state was reached after approximately 44 cases for Assistant A, 32 cases for Assistant B, and 41 cases for Assistant C. CONCLUSION: Analysis of the assistants' learning curves suggests that under reverse alignment conditions, assistants require participation in 30-40 cases before gaining surgical competence. These results have implications for training assistants for laparoscopic colorectal surgery.

What is the most cost-effective strategy to screen for second primary colorectal cancers in male cancer survivors in Korea?

AIM: To identify a cost-effective strategy of second primary colorectal cancer (CRC) screening for cancer survivors in Korea using a decision-analytic model. METHODS: A Markov model estimated the clinical and economic consequences of a simulated 50-year-old male cancer survivors' cohort, and we compared the results of eight screening strategies: no screening, fecal occult blood test (FOBT) annually, FOBT every 2 years, sigmoidoscopy every 5 years, double contrast barium enema every 5 years, and colonoscopy every 10 years (COL10), every 5 years (COL5), and every 3 years (COL3). We included only direct medical costs, and our main outcome measures were discounted lifetime costs, life expectancy, and incremental cost-effectiveness ratio (ICER). RESULTS: In the base-case analysis, the non-dominated strategies in cancer survivors were COL5, and COL3. The ICER for COL3 in cancer survivors was $5593/life-year saved (LYS), and did not exceed $10,000/LYS in one-way sensitivity analyses. If the risk of CRC in cancer survivors is at least two times higher than that in the general population, COL5 had an ICER of less than $10,500/LYS among both good and poor prognosis of index cancer. If the age of cancer survivors starting CRC screening was decreased to 40 years, the ICER of COL5 was less than $7400/LYS regardless of screening compliance. CONCLUSION: Our study suggests that more strict and frequent recommendations for colonoscopy such as COL5 and COL3 could be considered as economically reasonable second primary CRC screening strategies for Korean male cancer survivors.