The Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study.

Diverticular disease is an increasingly common issue, with a variety of clinical presentations and treatment options. However, very few prospective cohort studies explore outcomes between the different presentations and treatments. The Diverticular Disease Registry (DDR Trial) is a multicenter, prospective, observational cohort study on behalf of the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network. The DDR Trial aims to investigate the short-term postoperative and long-term quality of life outcomes in patients undergoing surgery or medical treatments for diverticular disease. DDR Trial is open to participation by all tertiary-care hospitals. DDR Trial has been registered at ClinicalTrials.gov (NCT04907383). Data collection will be recorded on Research Electronic Data Capture (REDCap) starting on June 1st, 2021 and will end after 5 years of recruitment. All adult patients with imaging-proven colonic diverticular disease (i.e., symptomatic colonic diverticulosis including diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease) will be included. The primary outcome of DDR Trial is quality of life assessment at 12-month according to the Gastrointestinal Quality of Life Index (GIQLI). The secondary outcome is 30-day postoperative outcomes according to the Clavien-Dindo classification. DDR Trial will significantly advance in identifying the optimal care for patients with diverticular disease by exploring outcomes of different presentations and treatments. HIGHLIGHTS: Diverticular disease (i.e., diverticulitis, bleeding) has different treatments.This is a clinical protocol for the Diverticular Disease Registry (DDR Trial).DDR Trial is a multicenter, prospective, observational cohort study open to participation.DDR Trial will study short-term postoperative and long-term quality of life outcomes.Medical treatments, interventional radiology and surgery will be explored.

Is BMI a Factor in Compliance to Adjuvant Chemotherapy for Locally Advanced Rectal Cancer?

Background: Compliance to adjuvant chemotherapy (AC) for patients undergoing rectal surgery ranges from 43% to 73.6%. Reasons reported for not initiating or completing AC include onset of postoperative complications, drug toxicity, disease progression and/or patient preferences. Little is known regarding the impact of obesity on the compliance to AC in this setting. Methods: This multicenter, retrospective study analyzed compliance to AC and treatment-related morbidity in 511 patients having undergone surgery with curative intent for rectal cancer in six Italian colorectal centers between January 2013 and December 2017. Results: 70 patients were obese (BMI 30 kg/m2). The proportion of open procedures (22.9% vs. 13.4%) and conversions (14.3% vs. 4.8%) was greater in obese compared to non-obese patients (p 0.001). Median hospital stay was one day longer for obese patients (9 days vs. 10 days, p=0.038) while there was no statistically significant difference in the complication rate, whether overall (58.6% in obese vs. 52.3% in non-obese) or with a Clavien-Dindo score 3 (17.1% vs 10.9%). AC was offered to 49/70 (70%) patients in the obese group and 306/441 (69.4%) in the non-obese group (p=0.43). There was no statistically significant difference in AC compliance: 18.4% and 22.9% did not start AC, while 36.7% and 34.6%, started AC but did not complete the scheduled treatment (p=0.79) in the obese and non-obese group, respectively. Overall, 55% of patients who started AC successfully completed their adjuvant treatment. Conclusions: Obesity did not impact compliance to AC for locally advanced rectal cancer: compliance was poor in obese and non-obese patients with no statistically significant difference between the two groups. Major complication rate was not statistically significantly affected by increased BMI.

Surgical Approach to Transverse Colon Cancer: Analysis of Current Practice and Oncological Outcomes Using the National Cancer Database.

BACKGROUND: Surgical treatment for transverse colon cancer involves either extended colectomy or segmental resection, depending on the location of the tumor and surgeon perspective. However, the oncological safety of segmental resection has not yet been established in large cohort studies. OBJECTIVE: This study aims to compare segmental resection versus extended colectomy for transverse colon cancer in terms of oncological outcomes. DESIGN: This was a retrospective cohort study. SETTINGS: This study was conducted using a nationwide cohort. PATIENTS: A total of 66,062 patients who underwent colectomy with curative intent for transverse stage I to III adenocarcinoma were identified in the National Cancer Database (2004-2015). MAIN OUTCOME MEASURES: Patients were divided in 2 groups based on the type of surgery received (extended versus segmental resection). The primary outcome was overall survival. Secondary outcomes were 30- and 90-day mortality, length of hospital stay, and readmission rate within 30 days of surgical discharge. RESULTS: Extended colectomy was performed in 44,417 (67.2%) patients, whereas 21,645 (32.8%) patients underwent segmental resection. Extended colectomy was associated with lower survival at multivariate analysis (HR, 1.07; 95% CI, 1.04-1.10; p < 0.001). The subgroup analysis showed that extended resection was independently associated with poorer survival in mid transverse colon cancers (HR, 1.08; 95% CI, 1.04-1.12; p < 0.001) and in stage III tumors (HR, 1.11; 95% CI, 1.04-1.18; p < 0.001). The number of at least 12 harvested lymph nodes was an independent predictor of improved survival in both overall and subgroup analyses. LIMITATIONS: This study was limited by its retrospective design. CONCLUSION: Extended colectomy was not associated with a survival advantage compared with segmental resection. On the contrary, extended colectomy was associated with slightly poorer survival in mid transverse cancers and locally advanced tumors. Segmental resection was found to be safe when appropriate margins and adequate lymph node harvest were achieved. See Video Abstract at http://links.lww.com/DCR/B454. ABORDAJE QUIRRGICO DEL CNCER DE COLON TRANSVERSO ANLISIS DE LA PRCTICA ACTUAL Y LOS RESULTADOS ONCOLGICOS UTILIZANDO LA BASE DE DATOS NACIONAL DE CNCER: ANTECEDENTES:El tratamiento quirúrgico para el cáncer de colon transverso implica colectomía extendida o resección segmentaria, según la ubicación del tumor y la perspectiva del cirujano. Sin embargo, la seguridad oncológica de la resección segmentaria aún no se ha establecido en estudios de cohortes grandes.OBJETIVO:Este estudio tiene como objetivo comparar la resección segmentaria versus la colectomía extendida para el cáncer de colon transverso en términos de resultados oncológicos.DISEÑO:Este fue un estudio de cohorte retrospectivo.ESCENARIO:Este estudio se realizó utilizando una cohorte a nivel nacional.PACIENTES:Un total de 66,062 pacientes que se sometieron a colectomía con intención curativa por adenocarcinoma de colon transverso en estadio I-III fueron identificados en la Base de Datos Nacional del Cáncer (2004-2015).PRINCIPALES MEDIDAS DE RESULTADO:Los pacientes se dividieron en dos grupos según el tipo de cirugía recibida (resección extendida versus resección segmentaria). El resultado primario fue la supervivencia global. Los resultados secundarios fueron la mortalidad a los 30 y 90 días, la duración de la estancia hospitalaria y la tasa de reingreso dentro de los 30 días posteriores al alta quirúrgica.RESULTADOS:Se realizó colectomía extendida en 44,417 (67.2%) casos, mientras que 21,645 (32.8%) pacientes fueron sometidos a resección segmentaria. La colectomía extendida se asoció con una menor supervivencia en el análisis multivariado (HR 1.07 IC 95% 1.04-1.10; p <0.001). El análisis de subgrupos mostró que la resección extendida se asoció de forma independiente con una menor supervivencia en los cánceres de colon transverso medio (HR 1.08 IC 95% 1.04-1.12; p <0.001) y en tumores en estadio III (HR 1.11 IC 95% 1.04-1.18; p <0.001). Un número de al menos 12 ganglios linfáticos cosechados fue un predictor independiente de una mejor supervivencia en los análisis general y de subgrupos.LIMITACIONES:Este estudio estuvo limitado por su diseño retrospectivo.CONCLUSIÓN:La colectomía extendida no se asoció con una ventaja de supervivencia en comparación con la resección segmentaria. Por el contrario, la colectomía extendida se asoció con una supervivencia levemente menor en cánceres de colon transverso medio y tumores localmente avanzados. Se encontró que la resección segmentaria es segura cuando se logran los márgenes apropiados y la cosecha adecuada de ganglios linfáticos. Consulte Video Resumen en http://links.lww.com/DCR/B454.

4K ultra HD technology reduces operative time and intraoperative blood loss in colorectal laparoscopic surgery.

Background: HD systems are routinely used in laparoscopic surgery, 4K ultra HD monitors are mainly available within specialized, high-volume laparoscopic centers. The higher resolution of 4K ultra HD video could upgrade the surgical performance improving intraoperative and post-operative outcomes. Methods: We performed a retrospective comparative analysis of intraoperative parameters and post-operative outcomes in a cohort of patients operated on for elective laparoscopic procedures for colo-rectal cancer during two different time frames: 2017 procedures performed using the Visera Elite full HD technology (® Olympus America, Medical) and the 2018 procedures performed the Visera 4K Ultra HD System (® Olympus America, Medical). Results: There was a statistically significant reduction in operative time in patients operated on with the 4K ultra HD technology compared to HD technology (p < 0.05). Intraoperative blood loss was significantly reduced in patients operated in 2018 (p < 0.05). There were no statistically significant differences in complication rate and postoperative outcomes between the two groups.

High Versus Low Ligation of the Inferior Mesenteric Artery During Rectal Resection for Cancer: Oncological Outcomes After Three Years of Follow-Up From the HIGHLOW Trial.

Objectives: To determine the disease-free survival (DFS), disease-specific survival (DSS), and recurrence in patients who underwent laparoscopic low anterior rectal resection with total mesorectal excision (TME) with either high or low ligation of the inferior mesenteric artery (IMA). Background: The level of IMA ligation during anterior rectal resection with TME is still a matter of debate, especially in terms of oncological adequacy. Methods: Between June 2014 and December 2016, patients scheduled to undergo elective laparoscopic low anterior resection (LAR) and TME in 6 Italian nonacademic hospitals were randomized into 2 groups in the HIGHLOW Trial (ClinicalTrials.gov Identifier: NCT02153801) according to the level of IMA ligation: high ligation (HL) versus low ligation (LL). DFS, DSS, and recurrence were inquired. Recurrence was determined at 3, 6, 9, and 12 months and every 6 months thereafter. Patients and tumor characteristics as well as surgical outcomes were analyzed to identify risk factors for recurrence. Results: One hundred ninety-six patients from the HIGHLOW trial were analyzed. Median follow-up for DFS was 40.6 (interquartile range [IQR], 6-64.7) and 40 (IQR, 7.6-67.8), while median follow-up for DSS was 41.2 (IQR, 10.7-64.7) and 42.7 (IQR, 6-67.6) in the HL and LL groups, respectively. The 3-year DFS rate of HL and LL patients was 82.2% and 82.1% (P = 0.874), respectively. The 3-year DSS for HL and LL patients was 92.1% and 93.4% (P = 0.897), respectively. There was no statistically significant difference in the local recurrence rate (2% HL vs 2.1% LL), in the regional recurrence rate (3% HL vs 2.1% LL), and in the distant recurrence rate (12.9% HL vs 13.7% LL). Multivariate analysis found conversion to open surgery (hazard ratio [HR], 3.68; P = 0.001) and higher stage of disease (HR, 7.73; P < 0.001) to be significant determinant for DFS. Conclusions: The level of inferior mesenteric artery ligation during LAR and TME for rectal cancer does not affect DFS, DSS, and recurrence.

Symptomatic Uncomplicated Diverticular Disease and Incidence of Unexpected Abscess during Sigmoidectomy: A Multicenter Prospective Observational Study.

BACKGROUND: Symptomatic uncomplicated diverticular disease can affect patients' everyday routine. Considerable efforts have been made to identify clinical features that correlate to the severity of the disease. Unexpected intraoperative abscesses are reported in large retrospective series, showing how uncomplicated symptoms and presentations can underlie a complicated disease. The aim of this study was to investigate the incidence of pericolic or intramural abscess in patients undergoing elective sigmoidectomy for symptomatic uncomplicated diverticular disease and see if chronic symptoms correlate to the presence of an abscess. METHODS: Between January 2016 and June 2018, we prospectively collected data of patients who were given indication to elective sigmoidectomy for symptomatic uncomplicated diverticular disease. Patients were divided into 3 groups: acute resolving, smoldering, and atypical according to a previously described classification of uncomplicated diverticular disease. RESULTS: One hundred fifty-eight consecutive patients were enrolled in the study. The median age was 63 years (22- 88), and the mean body mass index was 26 (±7) kg/m2. There were 114 patients in the acute resolving group, 36 in the smoldering group, and 8 in the atypical group. An unexpected abscess was reported in 75 patients (47.5%) during surgery or pathological examination. The incidence of -abscess was greater for patient in the smoldering group (p = 0.0243). CONCLUSION: Our series of patients affected by symptomatic uncomplicated diverticular disease showed an incidence of unexpected pericolic or intramural abscess of 47.5%. Patients affected by smoldering diverticular disease presented a greater abscess rate.

Creation of a rectal cancer registry in Italy by the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network.

Background: The management of rectal cancer is multimodal and involves a multidisciplinary team of cancer specialists with expertise in medical oncology, surgical oncology, radiation oncology and radiology. It is crucial for highly specialized centers to collaborate via networks that aim to maintain uniformity in every aspect of treatment and rigorously gather patients' data, from the first clinical evaluation to the last follow-up visit. The Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network aims to create a rectal cancer registry. This will prospectively collect the data of patients operated on for non-metastatic rectal cancer in high volume colorectal surgical units through a well design pre-fashioned database for non-metastatic rectal cancer, in order to take all multidisciplinary aspects into consideration. Methods/Design: The protocol describes a multicenter prospective observational cohort study, investigating demographics, frailty, cancer-related features, surgical and radiological parameters, and oncological outcomes among patients with non-metastatic rectal cancer who are candidates for surgery with curative intent. Patients enrolled in the present registry will be followed up for 5 years after surgery. Discussion: Standardization and centralization of data collection for neoplastic diseases is a virtuous process for patient care. The creation of a register will allow the control of the quality of treatments provided and permit prospective and retrospective studies to be carried out on complete and reliable high quality data. Establishing data collection in a prospective and systematic fashion is the only possibility to preserve the enormous resource that each patient represents.

Compliance to Adjuvant Chemotherapy of Patients Who Underwent Surgery for Rectal Cancer: Report from a Multi-institutional Research Network.

INTRODUCTION: Adjuvant chemotherapy for locally advanced rectal cancer is associated with improved overall survival. However, recent evidence from randomized trials showed a compliance rate of 43 to 73%, which may affect efficacy. The aim of this multicenter retrospective analysis was to investigate the compliance rate to adjuvant treatment for patients who underwent rectal surgery for cancer. METHODS: Patients who underwent surgery with curative intent for rectal cancer in six Italian colorectal centers between January 2013 and December 2017 were retrospectively reviewed. Exclusion criteria were age less than 18 years, palliative or emergency surgery, and stage IV disease. Parameters of interest were patients' characteristics, preoperative tumor stage, neo-adjuvant chemoradiation therapy, intra-operative and postoperative outcomes. Although the participating centers referred to the same treatment guidelines for treatment, the chemotherapy regiment was not standardized across the institutions. Reasons for not starting adjuvant chemotherapy when indicated, interruption, and modification of drug regimen were collected to investigate compliance. RESULTS: A total of 572 patients were included in the analysis. Two hundred and fifty-two (44.1%) patients received neo-adjuvant chemoradiation therapy. All patients underwent high anterior rectal resection, low anterior rectal resection, or Miles' procedure. Of 399 patients with an indication to adjuvant chemotherapy, 176 (44.1%) completed the treatment as planned. Compliance for patients who started chemotherapy was 56% (95% CI 50.4-61.6%). Sixty-six patients interrupted the treatment, 76 patients significantly reduced the drug dose, and 41 patients had to switch to other therapeutic regimens. CONCLUSIONS: The present multicenter investigation reports a low compliance rate to adjuvant chemotherapy after rectal resection for cancer. Multidisciplinary teams should focus on future effort to improve compliance for these patients.

Low Ligation of Inferior Mesenteric Artery in Laparoscopic Anterior Resection for Rectal Cancer Reduces Genitourinary Dysfunction: Results From a Randomized Controlled Trial (HIGHLOW Trial).

OBJECTIVES: The aim of the present study was to compare the incidence of genitourinary (GU) dysfunction after elective laparoscopic low anterior rectal resection and total mesorectal excision (LAR + TME) with high or low ligation (LL) of the inferior mesenteric artery (IMA). Secondary aims included the incidence of anastomotic leakage and oncological outcomes. BACKGROUND: The criterion standard surgical approach for rectal cancer is LAR + TME. The level of artery ligation remains an issue related to functional outcome, anastomotic leak rate, and oncological adequacy. Retrospective studies failed to provide strong evidence in favor of one particular vascular approach and the specific impact on GU function is poorly understood. METHODS: Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian nonacademic hospitals were randomized to high ligation (HL) or LL of IMA after meeting the inclusion criteria. GU function was evaluated using a standardized survey and uroflowmetric examination. The trial was registered under the ClinicalTrials.gov Identifier NCT02153801. RESULTS: A total of 214 patients were randomized to HL (n = 111) or LL (n = 103). GU function was impaired in both groups after surgery. LL group reported better continence and less obstructive urinary symptoms and improved quality of life at 9 months postoperative. Sexual function was better in the LL group compared to HL group at 9 months. Urinated volume, maximum urinary flow, and flow time were significantly (P < 0.05) in favor of the LL group at 1 and 9 months from surgery. The ultrasound measured post void residual volume and average urinary flow were significantly (P < 0.05) better in the LL group at 9 months postoperatively. Time of flow worsened in both groups at 9 months compared to baseline. There was no difference in anastomotic leak rate (8.1% HL vs 6.7% LL). There were no differences in terms of blood loss, surgical times, postoperative complications, and initial oncological outcomes between groups. CONCLUSIONS: LL of the IMA in LAR + TME results in better GU function preservation without affecting initial oncological outcomes. HL does not seem to increase the anastomotic leak rate.

Intracorporeal Anastomosis Reduces Surgical Stress Response in Laparoscopic Right Hemicolectomy: A Prospective Randomized Trial.

Total laparoscopic right hemicolectomy is a procedure that involves an intracorporeal anastomosis. This approach may reduce tissue injury resulting in a significant lower surgical stress response (SSR) compared with the same procedure performed with an extracorporeal anastomosis. The purpose of this study was to compare the SSR level between 2 groups of patients undergoing laparoscopic right hemicolectomy with intracorporeal or extracorporeal anastomosis. From June 2015 to December 2016, 60 patients were enrolled and randomized. Interleukin-6, C-reactive protein, procalcitonin, white blood cell count, cortisol, prolactin, prealbumin, albumin, triglycerides, and transferrin were analyzed preoperatively and at 1, 3, and 5 days postoperatively. Interleukin-6 and C-reactive protein levels were significantly lower in the intracorporeal group on days 1, 3, and 5 postoperatively compared with the extracorporeal group. Gastrointestinal recovery was significantly earlier in the intracorporeal group. The intracorporeal anastomosis in laparoscopic right hemicolectomy reduces SSR, which may play a role in bowel recovery.

Tumor response evaluation after neoadjuvant chemotherapy in locally advanced gastric adenocarcinoma: a prospective, multi-center cohort study.

BACKGROUND: To verify the prognostic value of the pathologic and radiological tumor response after neoadjuvant chemotherapy in the treatment of locally advanced gastric adenocarcinoma. METHODS: A total of 67 patients with locally advanced gastric cancer (clinical ≥ T2 or nodal disease and without evidence of distant metastases) underwent perioperative chemotherapy (ECF or ECX regimen) from December 2009 through June 2015 in two surgical units. Histopathological and radiological response to chemotherapy were evaluated by using tumor regression grade (TRG) (Becker's criteria) and volume change assessed by CT. RESULTS: Fifty-one (86%) patients completed all chemotherapy scheduled cycles successfully and surgery was curative (R0) in 64 (97%) subjects. The histopathological analysis showed 19 (29%) specimens with TRG1 (less than 10% of vital tumor left) and 25 (37%) patients had partial or complete response (CR) assessed by CT scan. Median disease free survival (DFS) and overall survival (OS) were 25.70 months (range, 14.52-36.80 months) and 36.60 months (range, 24.3-52.9 months), respectively. The median follow up was 27 months (range, 5.00-68.00 months). Radiological response and TRG were found to be a prognostic factor for OS and DFS, while tumor histology was not significantly related to survival. CONCLUSIONS: Both radiological response and TRG have been shown as promising survival markers in patients treated with perioperative chemotherapy for locally advanced gastric cancer. Other predictive markers of response to chemotherapy are strongly required.

Fast-track versus standard care in laparoscopic high anterior resection: a prospective randomized-controlled trial.

The value of fast-track (FT) multimodal recovery programs in improving hospitalization of surgical patients has been widely proved. The application of FT protocols to laparoscopic colorectal surgery seems to maximize the effects of the minimally invasive approach. The objectives of this randomized-controlled trial are to compare the short-term outcomes (bowel function, return to oral nutrition, day of discharge, fatigue, time to resume normal activities, functional capabilities, and readmission rate) of patients undergoing elective laparoscopic high anterior resection (HAR) following either a FT or a standard program. The prospective randomized-controlled trial included 52 consecutive patients undergoing elective laparoscopic HAR. Group 1 was treated with a FT rehabilitation program, and group 2 was treated with a standard care (SC) program. Patients were interviewed 14 and 30 days postoperatively. One patient in each group was excluded from the study. Mean hospital stay, time of first bowel movement, and bowel function resumption were significantly shorter in the FT group (P<0.05). Patients in the FT group referred more pain in day 0 versus patients in the SC group (P<0.05) even though the difference disappeared from day 1. Fatigue was significantly reduced at day 14 in the FT group compared with the SC group (P<0.01). Similarly, ability to resume the normal preoperative attitude (walking stairs, cooking, housekeeping, shopping, and walking outdoors) was significantly better at day 14 in the FT group (P<0.005). There was no significant difference between the 2 groups at day 30 for the same parameters. There were no readmissions in both the groups and no need for consultations from general practitioners. FT multimodal program is a safe approach effective on postoperative short-term outcome significantly reducing hospital stay. Early postoperative pain control needs to be optimized.