Effectiveness of personalized treatment stage-adjusted digital therapeutics in colorectal cancer: a randomized controlled trial.

BACKGROUND: Colorectal cancer survivors often experience decline in physical performance and poor quality of life after surgery and during adjuvant therapies. In these patients, preserving skeletal muscle mass and high-quality nourishment are essential to reduce postoperative complications and improve quality of life and cancer-specific survival. Digital therapeutics have emerged as an encouraging tool for cancer survivors. However, to the best of our knowledge, randomized clinical trials applying personalized mobile application and smart bands as a supportive tool to several colorectal patients remain to be conducted, intervening immediately after the surgical treatment. METHODS: This study is a prospective, multi-center, single-blinded, two-armed, randomized controlled trial. The study aims to recruit 324 patients from three hospitals. Patients will be randomly allocated to two groups for one year of rehabilitation, starting immediately after the operation: a digital healthcare system rehabilitation (intervention) group and a conventional education-based rehabilitation (control) group. The primary objective of this protocol is to clarify the effect of digital healthcare system rehabilitation on skeletal muscle mass increment in patients with colorectal cancer. The secondary outcomes would be the improvement in quality of life measured by EORTC QLQ C30 and CR29, enhanced physical fitness level measured by grip strength test, 30-sec chair stand test and 2-min walk test, increased physical activity measured by IPAQ-SF, alleviated pain intensity, decreased severity of the LARS, weight, and fat mass. These measurements will be held on enrollment and at 1, 3, 6 and 12 months thereafter. DISCUSSION: This study will compare the effect of personalized treatment stage-adjusted digital health interventions on immediate postoperative rehabilitation with that of conventional education-based rehabilitation in patients with colorectal cancer. This will be the first randomized clinical trial performing immediate postoperative rehabilitation in a large number of patients with colorectal cancer with a tailored digital health intervention, modified according to the treatment phase and patient condition. The study will add foundations for the application of comprehensive digital healthcare programs focusing on individuality in postoperative rehabilitation of patients with cancer. TRIAL REGISTRATION: NCT05046756. Registered on 11 May 2021.

Lateral Lymph Node Size and Tumor Distance From Anal Verge Accurately Predict Positive Lateral Pelvic Lymph Nodes in Rectal Cancer: A Multi-Institutional Retrospective Cohort Study.

BACKGROUND: Lateral pelvic lymph node dissection improves oncological outcomes in rectal cancer patients with suspected lateral pelvic lymph node metastasis. However, the indication for this procedure remains unclear. OBJECTIVE: This study aimed to identify the predictive factors for lateral lymph node metastasis and the indications for lateral pelvic lymph node dissection. DESIGN: A multi-institutional retrospective study. SETTINGS: This study was conducted at 3 university hospitals. PATIENTS: This study involved 105 patients with locally advanced mid/low rectal cancer and clinically suspected lateral pelvic lymph node metastasis who underwent total mesorectal excision with lateral pelvic lymph node dissection between 2015 and 2020. MAIN OUTCOME MEASURES: Indications were set using lateral pelvic lymph node metastasis-associated preoperative factors. RESULTS: Among 105 patients, 36 (34.3%) had pathologically confirmed lateral pelvic lymph node metastasis and 77 (73.3%) underwent preoperative chemoradiation. Tumors located within 5 cm distance from the anal verge ( p = 0.02) and initial node size ≥ 6 mm ( p = 0.001) were significant predictors of lateral pelvic lymph node metastasis. The sensitivity was 100% (36/36) with a cutoff of 6 mm for the initial node size and 94.4% (34/36) with a cutoff of 8 mm for the initial node size. When using initial node size cutoffs of 8 mm for anal verge-to-tumor distance of >5 cm and 6 mm for anal verge-to-tumor distance of ≤5 cm, the sensitivity of lateral pelvic lymph node metastasis was found to be 100%. LIMITATIONS: The retrospective design and small sample size were the limitations of this study. CONCLUSION: Initial node size and tumor height were significant predictors of lateral pelvic lymph node metastasis. This study proposed that an initial node size of ≥8 mm with an anal verge-to-tumor distance of >5 cm and ≥6 mm with an anal verge-to-tumor distance of ≤5 cm are optimal indications for lateral pelvic lymph node dissection in rectal cancer. See Video Abstract at http://links.lww.com/DCR/C101 . EL TAMAO DEL GANGLIO LINFTICO LATERAL Y LA DISTANCIA DEL TUMOR DESDE EL BORDE ANAL PREDICEN CON PRECISIN LOS GANGLIOS LINFTICOS PLVICOS LATERALES POSITIVOS EN EL CNCER DE RECTO UN ESTUDIO DE COHORTE RETROSPECTIVO MULTIINSTITUCIONAL: ANTECEDENTES:La disección de los ganglios linfáticos pélvicos laterales mejora los resultados oncológicos en pacientes con cáncer de recto con sospecha de metástasis en los ganglios linfáticos pélvicos laterales. Sin embargo, la indicación de este procedimiento sigue sin estar clara.OBJETIVO:Nuestro objetivo fue identificar los factores predictivos de la metástasis de los ganglios linfáticos laterales y las indicaciones para la disección de los ganglios linfáticos pélvicos laterales.DISEÑO:Estudio retrospectivo multiinstitucional.AJUSTES:Este estudio se realizó en tres hospitales universitarios.PACIENTES:Este estudio involucró a 105 pacientes con cáncer de recto medio/bajo localmente avanzado y sospecha clínica de metástasis en los ganglios linfáticos pélvicos laterales que se sometieron a una escisión mesorrectal total con disección de los ganglios linfáticos pélvicos laterales entre 2015 y 2020.PRINCIPALES MEDIDAS DE RESULTADO:Las indicaciones se establecieron utilizando los factores preoperatorios asociados con la metástasis de los ganglios linfáticos pélvicos laterales.RESULTADOS:Entre 105 pacientes, 36 (34,3%) tenían metástasis en los ganglios linfáticos pélvicos laterales confirmada patológicamente y 77 (73,3%) se sometieron a quimiorradiación preoperatoria. Los tumores ubicados dentro de los 5 cm desde el borde anal ( p = 0,02) y el tamaño inicial del ganglio ( p = 0,001) fueron predictores significativos de metástasis en los ganglios linfáticos pélvicos laterales. La sensibilidad fue del 100 % (36/36), con un punto de corte de 6 mm para el tamaño inicial del ganglio, seguido de 8 mm para el tamaño inicial del ganglio (94,4%, 34/36). Cuando se utilizó un tamaño de corte inicial del ganglio de 8 mm para una distancia entre el borde anal y el tumor >5 cm y 6 mm para una distancia entre el borde anal y el tumor ≤5 cm, la sensibilidad de la metástasis en los ganglios linfáticos pélvicos laterales fue del 100 %.LIMITACIONES:El diseño retrospectivo y el pequeño tamaño de la muestra.CONCLUSIONES:El tamaño inicial del ganglio y la altura del tumor fueron predictores significativos de metástasis en los ganglios linfáticos pélvicos laterales. Este estudio propuso que un tamaño de ganglio inicial de ≥8 mm con un tumor a >5 cm del margen anal y ≥6 mm con un tumor a ≤5 cm del margen anal son indicaciones óptimas para la disección de los ganglios linfáticos pélvicos laterales en el cáncer de recto. Consulte Video Resumen en http://links.lww.com/DCR/C101 . (Traducción-Dr. Yolanda Colorado ).

Immediate urinary catheter removal after colorectal surgery with the enhanced recovery after surgery protocol.

PURPOSE: The Enhanced Recovery After Surgery protocol for colorectal surgery recommends early urinary catheter (UC) removal after surgery. However, the optimal timing remains controversial. We aimed to evaluate the safety of immediate UC removal and risk factors of postoperative urinary retention (POUR) after colorectal cancer surgery. METHODS: From November 2019 and April 2022, patients who underwent elective colorectal cancer surgery at Seoul St. Mary's hospital were collected retrospectively. A UC was inserted in the operating room after general anesthesia and removed in the operating room immediately after surgery. The primary outcome was the occurrence of POUR following immediate UC removal after surgery, and the secondary outcomes were the identification of POUR-related risk factors and postoperative complications. RESULTS: Among 737 patients, 81 (10%) had POUR immediately after UC removal. No patient had urinary tract infection. The incidence of POUR was significantly higher in male and in those with a history of urinary disease. However, there were no significant differences in tumor location, surgical procedure, or approach. The mean operative time was significantly longer in the POUR group. Postoperative morbidity and mortality rates did not differ significantly between two groups. Multivariate analysis showed that risk factors for POUR were male, a history of urinary disease, and intrathecal morphine injection. CONCLUSIONS: Immediate removal of UC immediately after colorectal surgery is safe and feasible in the trend of ERAS. Male, a history of benign prostatic hyperplasia, and intrathecal morphine injection were risk factors for POUR.

Long-term outcomes of endoscopic papillectomy for ampullary adenoma with high-grade dysplasia or adenocarcinoma: a propensity score-matched analysis.

BACKGROUND: Evidence of endoscopic papillectomy (EP) for ampullar adenoma with high-grade dysplasia (HGD) or adenocarcinoma is insufficient. Here we investigated the long-term outcomes of the advanced ampullary tumors treated by EP with careful surveillance comparing to subsequent surgery after EP. METHODS: Patients treated with EP for ampullary adenoma with HGD or adenocarcinoma from the multi-center retrospective Korean cohort of ampulla of Vater tumor were categorized into EP alone versus EP with subsequent surgery groups. The overall survival (OS) and recurrence-free survival (RFS) were analyzed for unmatched and matched cohorts using propensity score with nearest neighbor method. RESULTS: During a median 43.3 months of follow-up, 5-year OS was not significantly different between the EP alone and EP surgery groups (91.9% vs. 82.3%, P = 0.443 for unmatched cohort; 89.2% vs. 82.3%, P = 0.861 for matched cohort, respectively). Furthermore, 5-year RFS was not significantly different between the two groups (82.1% vs. 86.7%, P = 0.520 for unmatched cohort; 66.1% vs. 86.7%, P = 0.052 for matched cohort, respectively). However, the patients with positive both (lateral and deep) margins showed significantly poorer survival outcomes than those with negative margins within the EP alone group (P = 0.007). CONCLUSION: EP alone with careful surveillance showed comparable survival outcomes to those of EP with subsequent surgery for ampullar HGD or adenocarcinoma. Resection margin status could be a parameter to determine whether to perform subsequent radical surgery after EP.

Long-term outcomes after endoscopic versus surgical resection of T1 colorectal carcinoma.

BACKGROUND: The long-term outcomes of patients with T1 colorectal cancer (CRC) who undergo endoscopic and/or surgical treatment are not well understood. Invasive CRC confined to the colonic submucosa (T1 CRC) is challenging in terms of clinical decision-making. We compared the long-term outcomes of T1 CRC by treatment method. METHODS: We examined 370 patients with pathological T1 CRC treated between 2000 and 2015 at Seoul St. Mary's Hospital. In total, 93 patients underwent endoscopic resection (ER) only, 82 underwent additional surgery after ER, and 175 underwent surgical resection only. Patients who did not meet the curative criteria were defined as "high-risk." High-risk patients were classified into three groups according to the treatment modalities: ER only (Group A: 35 patients), additional surgery after ER (Group B: 72 patients), and surgical resection only (Group C: 133 patients). The recurrence-free and overall survival (OS) rates, and factors associated with recurrence and mortality, were analyzed. Factors associated with lymph node metastasis (LNM) were subjected to multivariate analysis. RESULTS: Of the 370 patients, 7 experienced recurrence and 7 died. All recurrences occurred in the high-risk group and two deaths were in the low-risk group. In high-risk groups, there was no significant group difference in recurrence-free survival (P = 0.511) or OS (P =0.657). Poor histology (P =0.042) was associated with recurrence, and vascular invasion (P =0.044) with mortality. LNMs were observed in 30 of 277 patients who underwent surgery either initially or secondarily. Lymphatic invasion was significantly associated with the incidence of LNM (P < 0.001). CONCLUSIONS: ER prior to surgery did not affect the prognosis of high-risk T1 CRC patients, and did not worsen the clinical outcomes of patients who required additional surgery. Lymphatic invasion was the most important predictor of LNM.

Increased incidence of indeterminate pancreatic cysts and changes of management pattern: Evidence from nationwide data.

BACKGROUND: Pancreatic cysts are common. However, most studies are based on data collected from individual centers. The present study aimed to evaluate the changes of management patterns for pancreatic cystic lesions (PCLs) by analyzing large epidemiologic data. METHODS: Between January 2007 and December 2018, information regarding pancreatic cystic lesions was acquired from the nationwide Health Insurance Review and Assessment Service database in Korea. RESULTS: The final number of patients with pancreatic cysts was 165 277 among the total claims for reimbursement of 855 983 associated with PCLs over 12 years. The total number of claims were increased from 19 453 in 2007 to 155 842 in 2018 and the prevalence increased from 0.04% to 0.23%. For 12 years, 2874 (1.7%) had pancreatic cancer and 8212 (5.0%) underwent surgery, and 36 had surgery for twice (total 8248 pancreatectomy). After ruling out claims from the first 3 years of washout period, the incidence increased from 9891 to 24 651 and the crude incidence rate of PCLs expanded from 19.96 per 100 000 to 47.77 per 100 000. Compared to specific neoplasm codes (D136 or D377), the use of pancreatic cyst code (K862) has been remarkably increased and the most common since 2010. The annual number of pancreatectomies increased from 518 to 861 between 2007 and 2012, and decreased to 596 until 2018. The percentage of pancreatic cancer in patients who received pancreatectomy increased from 5.6% in 2007 to 11.7% in 2018. CONCLUSIONS: The incidence of PCLs is rapidly increasing. Among PCLs, indeterminate cyst is increasing outstandingly. A trend of decreasing in the number of resections and increasing cancer rates among resected cysts may be attributed to the updated international guidelines.

Clinical effect of rectus sheath block compared to intrathecal morphine injection for minimally invasive colorectal cancer surgery: a propensity score-matched study.

PURPOSE: To evaluate the postoperative outcomes of a multimodal perioperative pain management protocol with rectus sheath blocks (RSBs) or intrathecal morphine (ITM) injection for minimally invasive colorectal cancer surgery. METHODS: A total of 112 patients underwent minimally invasive colorectal surgery. Forty-one patients underwent RSB (group 1), whereas 71 patients underwent ITM (group 2) in addition to multimodal pain management using enhanced recovery after the surgery protocol. To adjust for the baseline differences and selection bias, baseline characteristics and postoperative outcomes were compared using propensity score matching. RESULTS: Forty patients were evaluated in each group. There was no significant difference in the length of hospital stay between the two groups. According to the Comprehensive Complication Index (CCI) score, the postoperative complication rate was significantly lower in the RSB group (3.0 ± 7.8) than in the ITM group (8.1 ± 10.9; p = 0.016). During the first 24 h after surgery, the median postoperative visual analog scale score was significantly higher in the RSB group than in the ITM group (2.0 ± 1.1 vs. 1.5 ± 1.2; p = 0.048). Postoperative morphine use was also significantly higher in the RSB group than in the ITM group in the first 24 h (23.7 ± 19.8 vs 11.6 ± 15.6%; p = 0.003) and 48 h (16.9 ± 24.8 vs. 7.5 ± 11.9; p = 0.036) after surgery. Significant urinary retention occurred after the in the RSB and ITM groups (5% vs. 45%; p < 0.001). CONCLUSION: Although the RSB group had higher morphine use during the first 48 h after surgery, the length of hospital stay remained the same and the complications were less in terms of the CCI score. Thus, transperitoneal RSB is a safe and feasible approach for postoperative pain management following minimally invasive procedures.

Use of ascitic CEA levels as a predictive value for distant metastasis in high-risk stage II and III colorectal cancer.

PURPOSE: This study aimed to analyze the effect of ascitic carcinoembryonic antigen (CEA) levels on the long-term oncologic outcomes of colorectal cancer (CRC) following curative treatment. METHODS: A total of 191 patients with stage II/III CRC were included. CEA was analyzed on the peritoneal fluid samples taken at the start of each surgery. Long-term oncologic outcomes were analyzed using known risk factors for recurrence in CRC. RESULT: Multivariate analysis of recurrence showed that lymphatic invasion (hazards ratio (HR) 2.7, 95% confidence interval (CI) 1.1-7, p = 0.038), vascular invasion (HR 2.8, 95% CI 1.2-6.3, p = 0.013), mucinous cancer (HR 3.6, 95% CI 1.3-10.1, p = 0.017), and peritoneal fluid CEA exceeding 5 ng/dl (odds ratio 3.1, 95% CI 1.2-7.7, p = 0.017) were significant risk factors. There were 14 patients with liver metastasis, 11 of whom had high ascitic CEA levels and no peritoneal metastasis. Additionally, eight had lung metastasis, and seven of them had high ascitic CEA levels. CONCLUSION: High ascitic CEA levels showed significantly lower disease-free survival and were significantly associated with distant metastasis in the lung and liver.

Quantitative evaluation of colon perfusion after high versus low ligation in rectal surgery by indocyanine green: a pilot study.

BACKGROUND: In the field of rectal cancer surgery, there remains ongoing debate on the merits of high ligation (HL) and low ligation (LL) of the inferior mesenteric artery (IMA) in terms of perfusion and anastomosis leakage. Recently, infrared fluorescence of indocyanine green (ICG) imaging has been used to evaluate perfusion status during colorectal surgery. OBJECTIVE: The purpose of this study is to compare the changes in perfusion status between HL and LL through quantitative evaluation of ICG. METHODS: Patients with rectosigmoid or rectal cancer were randomized into a high or LL group. ICG was injected before and after IMA ligation, and region of interest (ROI) values were measured by an image analysis program (HSL video©). RESULTS: From February to July 2020, 22 patients were enrolled, and 11 patients were assigned to each group. Basic demographics were similar between the two groups, except for albumin level and cardiac ejection fraction. There were no significant differences in F_max between the two groups, but T_max was significantly higher and Slope_max was significantly lower in the HL group than in the LL group. Anastomosis leakage was significantly associated with neoadjuvant chemoradiation and F_max. CONCLUSION: After IMA ligation, T_max increased and Slope_max decreased significantly in the HL group. However, the intensity of perfusion status (F_max) did not change according to the level of IMA ligation.

Initial experience of laparoscopic complete mesocolic excision with D3 lymph node dissection for right colon cancer using Artisential®, a new laparoscopic articulating instrument.

Background: Laparoscopic complete mesocolic excision (CME) with D3 lymph node dissection for the right colon is becoming popular, but still technically challenging. Several articulating laparoscopic instruments had been introduced to reduce technical difficulties; however, those were not practical. This study aimed to report the first clinical experience of using ArtiSential®, a new laparoscopic articulating instrument in laparoscopic complete mesocolic with D3 lymph node dissection for right colon cancer. Patients and Methods: This was a retrospective, single-institution, consecutive case study. From October 2018 to March 2020, a total of 33 patients underwent laparoscopic right hemicolectomy using ArtiSential®, a new articulating instrument. We compared the short-term outcomes of patients who underwent surgery using ArtiSential® (AG) to the conventional instrument (CG). Results: In total, there were 33 cases in AG and 43 cases in CG. There were no significant differences in operation time (141.0 ± 22.5 vs. 156.0 ± 50.6 min, P = 0.09), mean estimated blood loss (46.8 ± 36.2 vs. 100.8 ± 300.6 ml, P = 0.31) and intra-operative and post-operative complications. However, the number of harvested lymph nodes was higher and the length of hospital stay was shorter in AG than in CG (32.6 ± 12.2 vs. 24.6 ± 7.4, P < 0.01 and 3.0 ± 1.2 vs. 4.1 ± 2.2 days, P = 0.01, respectively). Conclusions: Laparoscopic CME with D3 lymph node dissection for right colon cancer using ArtiSential®, the new articulating laparoscopic instrument is safe and technically feasible.

Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial.

OBJECTIVE: To compare short-term perioperative outcomes of single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for colon cancer. SUMMARY BACKGROUND DATA: Although many studies reported short- and long-term outcomes of SPLS for colon cancer compared with MPLS, few have reported results of randomized controlled trials. METHODS: This was a multicenter, prospective, randomized controlled trial with a noninferiority design. It was conducted between August 2011 and June 2017 at 7 sites in Korea. A total of 388 adults (aged 19-85 yrs) with clinical stage I, II, or III adenocarcinoma of the ascending or sigmoid colon were enrolled and randomized. The primary endpoint was 30-day postoperative complication rates. Secondary endpoints were the number of harvested lymph nodes, length of the resection margin, postoperative pain, and time to functional recovery (bowel movement and diet). Patients were followed for 30 days after surgery. RESULTS: Among 388 patients, 359 (92.5%) completed the study (SPLS, n = 179; MPLS, n = 180). The 30-day postoperative complication rate was 10.6% in the SPLS group and 13.9% in the MPLS group (95% confidence interval, -10.05 to 3.05 percentage points; P < 0.0001). Total incision length was shorter in the SPLS group than in the MPLS group (4.6 cm vs 7.2 cm, P < 0.001), whereas the length of the specimen extraction site did not differ (4.4 cm vs 4.6 cm, P = 0.249). There were no significant differences between groups for all secondary endpoints and all other outcomes. CONCLUSIONS: Even though there was no obvious benefit to SPLS over MPLS when performing colectomy for cancer, our data suggest that SPLS is noninferior to MPLS and can be considered an option in selected patients, when performed by experienced surgeons.Trial registration: ClinicalTrials.gov Identifier: NCT01480128.

Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled study.

BACKGROUND: Two types of self-expandable metal stents (SEMS) are available for malignant distal biliary obstruction: fully covered SEMS (FCSEMS) and uncovered SEMS. FCSEMS can prevent stent ingrowth, but a major concern is spontaneous migration. This study aimed to determine whether the additional insertion of a double-pigtail plastic stent to anchor the FCSEMS can prevent migration. METHODS: 68 patients with unresectable, malignant, distal, biliary obstruction were included in this multicenter, randomized, superiority trial. The patients were randomly assigned to receive either the FCSEMS plus an anchoring plastic stent (n = 33) or an FCSEMS alone (n = 35). After placement of the FCSEMS, the anchoring stent was inserted inside the FCSEMS. The primary outcome was the rate of stent migration during the 6-month follow-up. The secondary outcomes were stent-related adverse events, stent patency, and survival rates. RESULTS: The baseline characteristics were similar between the two groups. The rate of stent migration at 6 months was significantly lower in patients with the FCSEMS plus anchoring stent (15 % vs. 40 %; P = 0.02). The mean stent patency was significantly longer in the FCSEMS plus anchoring group (237 days [95 % confidence interval [CI] 199 to 275] vs. 173 days [95 %CI 130 to 217]; P = 0.048). There were no significant differences in stent-related adverse events and overall survival rates at 6 months between the two groups. CONCLUSIONS: Our data suggest that the additional double-pigtail plastic stent anchored the FCSEMS to prevent migration and prolonged patency without any serious adverse events.

The development and validation of a predictive model for recurrence in rectal cancer based on radiological and clinicopathological data.

OBJECTIVE: To develop a prediction model for recurrence by incorporating radiological and clinicopathological prognostic factors in rectal cancer patients. METHODS: All radiologic and clinicopathologic data of 489 patients with rectal cancer, retrospectively collected from a single institution between 2009 and 2013, were used to develop a predictive model for recurrence using the Cox regression. The model performance was validated on an independent cohort between 2015 and 2017 (N = 168). RESULTS: Out of 489 derivative patients, 103 showed recurrence after surgery. The prediction model was constructed with the following four significant predictors: distance from anal verge, MR-based extramural venous invasion, pathologic nodal stage, and perineural invasion (HR: 1.69, 2.09, 2.59, 2.29, respectively). Each factor was assigned a risk score corresponding to HR. The derivation and validation cohort were classified by sum of risk scores into 3 groups: low, intermediate, and high risk. Each of these groups showed significantly different recurrence rates (derivation cohort: 13.4%, 35.3%, 61.5 %; validation cohort: 6.2%, 23.7%, 64.7%). Our new model showed better performance in risk stratification, compared to recurrence rates of tumor node metastasis (TNM) staging in the validation cohort (stage I: 3.6%, II: 12%, III: 30.2%). The area under the receiver operating characteristic curve of the new prediction model was higher than TNM staging at 3-year recurrence in the validation cohort (0.853 vs. 0.731; p = .009). CONCLUSIONS: The new risk prediction model was strongly correlated with a recurrence rate after rectal cancer surgery and excellent for selection of high-risk group, who needs more active surveillance. KEY POINTS: • Multivariate analysis revealed four significant risk factors to be MR-based extramural venous invasion, perineural invasion, nodal metastasis, and the short distance from anal verge among the radiologic and clinicopathologic data. • Our new recurrence prediction model including radiologic data as well as clinicopathologic data showed high predictive performance of disease recurrence. • This model can be used as a comprehensive approach to evaluate individual prognosis and helpful for the selection of highly recurrent group who needs more active surveillance.

Surgical rectus sheath block combined with multimodal pain management reduces postoperative pain and analgesic requirement after single-incision laparoscopic appendectomy: a retrospective study.

PURPOSE: This study aimed to evaluate the impact of multimodal postoperative pain management, performing a surgical rectus sheath (RS) block via ropivacaine injection into the surgical field after single-incision laparoscopic appendectomy (SILA). METHODS: Patients who underwent single-incision laparoscopic appendectomy (SILA) for acute appendicitis were divided into three groups and compared: group 1 (multimodal pain management that included intraoperative application of a surgical RS block), group 2 (conventional pain management with intravenous opioids), or group 3 (multimodal pain management without RS block). Forty, 53, and 42 patients were registered, respectively (Table 1). RESULTS: Time to start a liquid (1.2 ± 0.4 h) in group 1 was statistically significantly shorter than that in group 2 (16.3 ± 8.4 h; p < 0.001) and group 3 (4.93 ± 2.3 h; p < 0.001). The median and max postoperative VAS scores in group 1 (1.6 ± 1.2 and 2.2 ± 1.8, respectively) were statistically significantly lower than that in group 2 (3.0 ± 1.2 and 4.2 ± 1.9, respectively; p < 0.001 on both accounts) and group 3 (2.9 ± 0.6 and 3.4 ± 1.2, respectively; p < 0.001 on both accounts). The postoperative hospital stay for group 1 (17.0 ± 9.4 h) was shorter than that for group 2 (44.7 ± 27.9 h; p < 0.001) and group 3 (35.4 ± 20.9 h; p < 0.001). RS block was a significant factor for reducing length of hospital stay and postoperative pain in 24 h. CONCLUSIONS: A surgical RS block combined with multimodal pain management after SILA is a safe and effective method that results in reduced postoperative pain and shorter hospitalization.

Single-incision laparoscopic appendectomy is a safe procedure for beginners to perform: experience from 1948 cases.

BACKGROUND: Single-incision laparoscopic appendectomy (SIL-A) has recently become an option for treating appendicitis. The aim of this study was to evaluate the safety, feasibility, and surgical outcomes of SIL-A by residents and surgeons during the learning period. METHODS: A total of 1948 consecutive patients who underwent SIL-A from May 2008 to November 2014 were studied retrospectively. Surgeries were performed by residents and eight surgeons. Prior to the first case, surgeons and residents had been trained in a training protocol during the learning period. Three initial cases of SIL-A were performed under the supervision of experienced surgeons. Patients were divided into two groups: group 1 (learning period, n = 483), the first 40 cases by each surgeon and resident; and group 2 (experienced period, n = 1465), cases after the 40th procedure performed by each surgeon. Surgical results were compared between the two groups by performing propensity score matching analysis. RESULTS: After propensity score matching, there was no significant difference in patient demographics and characteristics of appendicitis between the two groups. The operating time was longer in group 1 than in group 2 (45.3 ± 18.0 vs. 33.9 ± 16.1 min, p < 0.001). The morbidity rate (7.0% vs. 6.5%, p = 0.795) was similar between the two groups. Readmission rate (2.1% vs. 1.3%, p = 0.414) and reoperation rate (0.8% vs. 0.8%, p = 0.348) were also similar between the two groups. However, the rate of incisional hernia occurrence (0.6% vs. 0%, p = 0.066) tended to be larger in group 1 than in group 2 without showing a significant difference. CONCLUSION: SIL-A is a technically feasible and safe procedure when it is performed by residents and surgeons during learning period under an appropriate training protocol. However, residents and surgeons in the learning period should perform it carefully to prevent incisional hernias.

Quality of life and patient satisfaction after single- and multiport laparoscopic surgery in colon cancer: a multicentre randomised controlled trial (SIMPLE Trial).

BACKGROUND: The clinical benefits of single-port laparoscopic surgery (SPLS) in patients with colon cancer patients are unclear because only a few studies have reported on the quality of life (QoL) of such patients. This study aimed to compare the QoL and patient satisfaction between SPLS and multiport laparoscopic surgery (MPLS) in colon cancer. METHODS: The multicentre randomised controlled SIngle-port versus MultiPort Laparoscopic surgEry (SIMPLE) trial included patients with colon cancer who underwent radical surgery at seven hospitals in South Korea. We performed a pre-planned secondary analysis of the QoL data of 359 patients from that trial. The QoL was surveyed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 preoperatively and at 1, 3, 6, and 12 months postoperatively. Patient satisfaction was measured with a 5-point questionnaire at these postoperative time points. RESULTS: Overall, 145 and 147 patients were included in the SPLS and MPLS groups, respectively. Most QoL domains were similar between the groups. In the subgroup analysis of patients without adjuvant chemotherapy, patients in the SPLS group presented with significantly better global health status (p = 0.017), fatigue (p = 0.047), and pain (p = 0.005) scores and tended to have improved physical (p = 0.055), emotional (p = 0.064), and social (p = 0.081) functioning, with marginal significance at 1 month postoperatively, compared to those in the MPLS group. Patient satisfaction regarding surgery (p = 0.002) and appearance of the abdominal scar (p = 0.002) was significantly higher with SPLS than with MPLS at 12 months postoperatively. CONCLUSION: Patients who underwent SPLS without adjuvant chemotherapy had better global health status, fatigue status, and pain at 1 month postoperatively; however, these improvements were minimal and temporary. In the near future, the effect of SPLS on postoperative QoL should be confirmed through a randomised controlled trial targeting the QoL in colon cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01480128.

Impact of intraoperative zero-balance fluid therapy on the occurrence of acute kidney injury in patients who had undergone colorectal cancer resection within an enhanced recovery after surgery protocol: a propensity score matching analysis.

PURPOSE: An enhanced recovery after surgery (ERAS) protocol for colorectal cancer resection encourages perioperative euvolemic status, and zero-balance fluid therapy is recommended for low-risk patients. Recently, several studies have reported concerns of increased acute kidney injury (AKI) in patients within an ERAS protocol. In the present study, we investigated the impact of intraoperative zero-balance fluid therapy within an ERAS protocol on postoperative AKI. METHODS: Patients who underwent elective surgery for primary colorectal cancer were divided into zero-balance and non-zero-balance fluid therapy groups according to intraoperative fluid amount and balance. After propensity score (PS) matching, 210 patients from each group were selected. Incidences of AKI were compared between the two groups according to the Kidney Disease Improving Global Outcomes criteria. Postoperative kidney functions and surgical outcomes were also compared. RESULTS: AKI was significantly higher in the zero-balance fluid therapy group compared to the non-zero-balance fluid therapy group (21.4% vs. 13.8%, p = 0.040) in PS-matched patients. The decrease in the estimated glomerular filtration rate on the day of surgery was significantly higher in the zero-balance fluid therapy group (- 5.9 mL/min/1.73 m2 vs. - 1.4 mL/min/1.73 m2, p = 0.005). There were no differences in general morbidity or mortality rate, although surgery-related complications were more common in the zero-balance group. CONCLUSIONS: Despite the proven benefits of zero-balance fluid therapy in colorectal ERAS protocols, care should be taken to monitor for postoperative AKI. Further studies regarding the clinical significance of postoperative AKI occurrence and optimised intraoperative fluid therapy are needed in a colorectal ERAS setting.

Prognostic role of pre-sarcopenia and body composition with long-term outcomes in obstructive colorectal cancer: a retrospective cohort study.

BACKGROUND: The clinical significance of pre-sarcopenia in colorectal cancer obstruction has not yet been described. The present study aimed to determine the short- and long-term oncologic impacts of pre-sarcopenia in obstructive colorectal cancer. METHODS: We retrospectively analyzed 214 patients with obstructive colon cancer between January 2004 and December 2013. Initial staging computed tomography (CT) scans identified pre-sarcopenia and visceral obesity by measuring the muscle and visceral fat areas at the third lumbar vertebra level. Both short-term postoperative and long-term oncologic outcomes were analyzed. RESULTS: Among all 214 patients, 71 (33.2%) were diagnosed with pre-sarcopenia. Pre-sarcopenia had a negative oncologic impact in both disease-free survival (DFS) and overall survival (OS), (hazard ratio [HR] = 1.86, 95% confidence interval [CI] 1.04-3.13, p = 0.037, and HR = 1.92, CI 1.02-3.60, p = 0.043, respectively). Visceral adiposity, body mass index (BMI), and neutrophil-lymphocyte ratio (NLR) did not significantly impact DFS and OS. CONCLUSION: Pre-sarcopenia is a clinical factor significantly associated with OS and DFS but not with short-term complications in obstructive colorectal cancer. In future, prospective studies should incorporate body composition data in patient risk assessments and oncologic prediction tools.

Korean Society of Coloproctology (KSCP) trial of cONsolidation Chemotherapy for Locally advanced mid or low rectal cancer after neoadjUvant concurrent chemoraDiothErapy: a multicenter, randomized controlled trial (KONCLUDE).

BACKGROUND: Neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) has been a standard treatment option for locally advanced rectal cancer with improved local control. However, systemic recurrence despite neoadjuvant CRT remained unchanged. The only significant prognostic factor proven to be important was pathologic complete response (pCR) after neoadjuvant CRT. Several efforts have been tried to improve survival of patients who treated with neoadjuvant CRT and to achieve more pCR including adding cytotoxic chemotherapeutic agents, chronologic modification of chemotherapy schedule or adding chemotherapy during the perioperative period. Consolidation chemotherapy is adding several cycles of chemotherapy between neoadjuvant CRT and TME. It could increase pCR rate, subsequently could show better oncologic outcomes. METHODS: Patients with advanced mid or low rectal cancer who received neoadjuvant CRT will be included after screening. They will be randomized and assigned to undergo TME followed by 8 cycles of adjuvant chemotherapy (control arm) or receive 3 cycles of consolidation chemotherapy before TME, and receive 5 cycles of adjuvant chemotherapy (experimental arm). The primary endpoints are pCR and 3-year disease-free survival (DFS), and the secondary endpoints are radiotherapy-related complications, R0 resection rate, tumor response rate, surgery-related morbidity, and peripheral neuropathy at 3 year after the surgery. The authors hypothesize that the experimental arm would show a 15% improvement in pCR (15 to 30%) and in 3-year DFS (65 to 80%), compared with the control arm. The accrual period is 2 years and the follow-up period is 3 years. Based on the superiority design, one-sided log-rank test with α-error of 0.025 and a power of 80% was conducted. Allowing for a drop-out rate of 10%, 358 patients (179 per arm) will need to be recruited. Patients will be followed up at every 3 months for 2 years and then every 6 months for 3 years after the last patient has been randomized. DISCUSSION: KONCLUDE trial aims to investigate whether consolidation chemotherapy shows better pCR and 3-year DFS than adjuvant chemotherapy alone for the patients who received neoadjuvant CRT for locally advanced rectal cancer. This trial is expected to provide evidence to support clear treatment guidelines for patients with locally advanced rectal cancer. TRIAL REGISTRATION: Clinicaltrials.gov NCT02843191 (First posted on July 25, 2016).

Procalcitonin as a Decision-Supporting Marker of Urgent Biliary Decompression in Acute Cholangitis.

BACKGROUND AND AIM: This study aimed to evaluate the association of serum procalcitonin (PCT) at hospital presentation with disease severity and clinical deterioration to septic shock in acute cholangitis. METHODS: This study included consecutive patients with a diagnosis of acute cholangitis who presented to the emergency department and underwent biliary drainage. PCT and blood culture tests were conducted at the time of initial presentation. Patients were categorized into three groups based on disease severity. White blood cell count, levels of C-reactive protein and PCT were compared regarding the following: cholangitis severity, blood culture positivity, and clinical deterioration to septic shock. RESULTS: A total of 204 consecutive patients were enrolled, with grade I severity in 39 (19.1%), grade II in 139 (68.1%), and grade III in 26 (12.7%). The numbers of patients with blood culture positivity and clinical deterioration were 6 (15.4%) and 1 (2.6%) in grade I, 45 (32.4%) and 4 (2.9%) in grade II, and 14 (53.8%) and 1 (5.6%) in grade III cholangitis, respectively. Only PCT was significantly associated with blood culture positivity (3.25 vs 0.62 ng/mL; P = 0.001) and clinical deterioration (9.11 vs 0.89 ng/mL; P = 0.040). The cutoff value of PCT for clinical deterioration to septic shock among patients with grade I and II was 3.77 ng/mL (sensitivity of 80.0% and specificity of 74.0%). CONCLUSION: PCT could be a promising marker of clinical deterioration to septic shock in acute cholangitis. Therefore, PCT might be used as a decision-supporting biomarker for urgent biliary decompression.