Safety of laparoscopic cholecystectomy performed by trainee surgeons with different cholangiographic techniques (SCOTCH): a prospective non-randomized trial on the impact of fluorescent cholangiography during laparoscopic cholecystectomy performed by trainees.

AIMS: The identification of the anatomical components of the Calot's Triangle during laparoscopic cholecystectomy (LC) might be challenging and its difficulty may increase when a surgical trainee (ST) is in charge, ultimately allegedly affecting also the incidence of common bile duct injuries (CBDIs). There are various methods to help reach the critical view of safety (CVS): intraoperative cholangiogram (IOC), critical view of safety in white light (CVS-WL) and near-infrared fluorescent cholangiography (NIRF-C). The primary objective was to compare the use of these techniques to obtain the CVS during elective LC performed by ST. METHODS: This was a multicentre prospective observational study (Clinicalstrials.gov Registration number: NCT04863482). The impact of three different visualization techniques (IOC, CVS-WL, NIRF-C) on LC was analyzed. Operative time and time to achieve the CVS were considered. All the participating surgeons were also required to fill in three questionnaires at the end of the operation focusing on anatomical identification of the general task and their satisfaction. RESULTS: Twenty-nine centers participated for a total of 338 patients: 260 CVS-WL, 10 IOC and 68 NIRF-C groups. The groups did not differ in the baseline characteristics. CVS was considered achieved in all the included case. Rates were statistically higher in the NIR-C group for common hepatic and common bile duct visualization (p = 0.046; p < 0.005, respectively). There were no statistically significant differences in operative time (p = 0.089) nor in the time to achieve the CVS (p = 0.626). Three biliary duct injuries were reported: 2 in the CVS-WL and 1 in the NIR-C. Surgical workload scores were statistically lower in every domain in the NIR-C group. Subjective satisfaction was higher in the NIR-C group. There were no other statistically significant differences. CONCLUSIONS: These data showed that using NIRF-C did not prolong operative time but positively influenced the surgeon's satisfaction of the performance of LC.

IMMUNOREACT 6: weak immune surveillance characterizes early-onset rectal cancer.

BACKGROUND: Colon cancer in young patients is often associated with hereditary syndromes; however, in early-onset rectal cancer, mutations of these genes are rarely observed. The aim of this study was to analyse the features of the local immune microenvironment and the mutational pattern in early-onset rectal cancer. METHODS: Commonly mutated genes were analysed within a rectal cancer series from the University Hospital of Padova. Mutation frequency and immune gene expression in a cohort from The Cancer Genome Atlas ('TCGA') were compared and immune-cell infiltration levels in the healthy rectal mucosa adjacent to rectal cancers were evaluated in the IMMUNOlogical microenvironment in REctal AdenoCarcinoma Treatment 1 and 2 ('IMMUNOREACT') series. RESULTS: In the authors' series, the mutation frequency of BRAF, KRAS, and NRAS, as well as microsatellite instability frequency, were not different between early- and late-onset rectal cancer. In The Cancer Genome Atlas series, among the genes with the most considerable difference in mutation frequency between young and older patients, seven genes are involved in the immune response and CD69, CD3, and CD8ß expression was lower in early-onset rectal cancer. In the IMMUNOlogical microenvironment in REctal AdenoCarcinoma Treatment 1 and 2 series, young patients had a lower rate of CD4+ T cells, but higher T regulator infiltration in the rectal mucosa. CONCLUSION: Early-onset rectal cancer is rarely associated with common hereditary syndromes. The tumour microenvironment is characterized by a high frequency of mutations impairing the local immune surveillance mechanisms and low expression of immune editing-related genes. A constitutively low number of CD4 T cells associated with a high number of T regulators indicates an imbalance in the immune surveillance mechanisms.

Can 68 Ga-PSMA positron emission tomography and multiparametric MRI guide treatment for biochemical recurrence after radical prostatectomy?

OBJECTIVE: To evaluate the role of multiparametric magnetic resonance imaging (mpMRI) and Gallium-68 (68 Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) in guiding salvage therapy for patients with biochemical recurrence (BCR) post-radical prostatectomy. PATIENTS AND METHODS: Patients were evaluated with paired mpMRI and 68 Ga-PSMA PET/CT scans for BCR (prostate-specific antigen [PSA] >0.2 ng/mL). Patient, tumour, PSA and imaging characteristics were analysed with descriptive statistics. RESULTS: A total of 117 patients underwent paired scans to investigate BCR, of whom 53.0% (62/117) had detectable lesions on initial scans and 47.0% (55/117) did not. Of those without detectable lesions, 8/55 patients proceeded to immediate salvage radiotherapy (sRT) and 47/55 were observed. Of patients with negative imaging who were initially observed, 46.8% (22/47) did not reach threshold for repeat imaging, while 53.2% were rescanned due to rising PSA levels. Of these rescanned patients, 31.9% (15/47) were spared sRT due to proven distant disease, or due to absence of disease on repeat imaging. Of the original 117 patients, 53 (45.3%) were spared early sRT due to absence of disease on imaging or presence of distant disease, while those undergoing delayed sRT still maintained good PSA responses. Of note, patients with high-risk features who underwent sRT despite negative imaging demonstrated satisfactory PSA responses to sRT. Study limitations include the observational design and absence of cause-specific or overall survival data. CONCLUSION: Our findings support the use of mpMRI and 68 Ga-PSMA PET/CT in guiding timing and necessity of salvage therapy tailored to detected lesions, with potential to reduce unnecessary sRT-related morbidity. Larger or randomized trials are warranted to validate this.

Protective ileostomy creation after anterior resection of the rectum: Shared decision-making or still subjective?

AIM: The choice of whether to perform protective ileostomy (PI) after anterior resection (AR) is mainly guided by risk factors (RFs) responsible for the development of anastomotic leakage (AL). However, clear guidelines about PI creation are still lacking in the literature and this is often decided according to the surgeon's preferences, experiences or feelings. This qualitative study aims to investigate, by an open-ended question survey, the individual surgeon's decision-making process regarding PI creation after elective AR. METHOD: Fifty four colorectal surgeons took part in an electronic survey to answer the questions and describe what usually led their decision to perform PI. A content analysis was used to code the answers. To classify answers, five dichotomous categories (In favour/Against PI, Listed/Unlisted RFs, Typical/Atypical, Emotions/Non-emotions, Personal experience/No personal experience) have been developed. RESULTS: Overall, 76% of surgeons were in favour of PI creation and 88% considered listed RFs in the question of whether to perform PI. Atypical answers were reported in 10% of cases. Emotions and personal experience influenced surgeons' decision-making process in 22% and 49% of cases, respectively. The most frequently considered RFs were the distance of the anastomosis from the anal verge (96%), neoadjuvant chemoradiotherapy (88%), a positive intraoperative leak test (65%), blood loss (37%) and immunosuppression therapy (35%). CONCLUSION: The indications to perform PI following rectal cancer surgery lack standardization and evidence-based guidelines are required to inform practice. Until then, expert opinion can be helpful to assist the decision-making process in patients who have undergone AR for adenocarcinoma.

Right Colectomy with Intracorporeal Anastomosis: A European Multicenter Propensity Score Matching Retrospective Study of Robotic Versus Laparoscopic Procedures.

BACKGROUND: This study aimed to compare the short- and long-term outcomes of robotic (RRC-IA) versus laparoscopic (LRC-IA) right colectomy with intracorporeal anastomosis using a propensity score matching (PSM) analysis based on a large European multicentric cohort of patients with nonmetastatic right colon cancer. METHODS: Elective curative-intent RRC-IA and LRC-IA performed between 2014 and 2020 were selected from the MERCY Study Group database. The two PSM-groups were compared for operative and postoperative outcomes, and survival rates. RESULTS: Initially, 596 patients were selected, including 194 RRC-IA and 402 LRC-IA patients. After PSM, 298 patients (149 per group) were compared. There was no statistically significant difference between RRC-IA and LRC-IA in terms of operative time, intraoperative complication rate, conversion to open surgery, postoperative morbidity (19.5% in RRC-IA vs. 26.8% in LRC-IA; p = 0.17), or 5-yr survival (80.5% for RRC-IA and 74.7% for LRC-IA; p = 0.94). R0 resection was obtained in all patients, and > 12 lymph nodes were harvested in 92.3% of patients, without group-related differences. RRC-IA procedures were associated with a significantly higher use of indocyanine green fluorescence than LRC-IA (36.9% vs. 14.1%; OR: 3.56; 95%CI 2.02-6.29; p < 0.0001). CONCLUSION: Within the limitation of the present analyses, there is no statistically significant difference between RRC-IA and LRC-IA performed for right colon cancer in terms of short- and long-term outcomes.

Minimally invasive versus open adrenalectomy for adrenocortical carcinoma: the keys surgical factors influencing the outcomes-a collective overview.

PURPOSE: Adrenocortical carcinoma (A.C.C.) is a rare tumour, often discovered at an advanced stage and associated with a poor prognosis. Surgery is the treatment of choice. We aimed to review the different surgical approaches trying to compare their outcome. METHODS: This comprehensive review has been carried out according to the PRISMA statement. The literature search was performed in PubMed, Scopus, the Cochrane Library and Google Scholar. RESULTS: Among all studies identified, 18 were selected for the review. A total of 14,600 patients were included in the studies, of whom 4421 were treated by mini-invasive surgery (M.I.S.). Ten studies reported 531 conversions from M.I.S. to an open approach (OA) (12%). Differences were reported for operative times as well as for postoperative complications more often in favour of OA, whereas differences for hospitalization time in favour of M.I.S. Some studies showed an R0 resection rate from 77 to 89% for A.C.C. treated by OA and 67 to 85% for tumours treated by M.I.S. The overall recurrence rate ranged from 24 to 29% for A.C.C. treated by OA and from 26 to 36% for tumours treated by M.I.S. CONCLUSIONS: OA should still be considered the standard surgical management of A.C.C. Laparoscopic adrenalectomy has shown shorter hospital stays and faster recovery compared to open surgery. However, the laparoscopic approach resulted in the worst recurrence rate, time to recurrence and cancer-specific mortality in stages I-III ACC. The robotic approach had similar complications rate and hospital stays, but there are still scarce results about oncologic follow-up.

Short- and long-term outcomes in ypT2 rectal cancer patients after neoadjuvant therapy and local excision: a multicentre observational study.

BACKGROUND: Although local excision (LE) after neoadjuvant treatment (NT) has achieved encouraging oncological outcomes in selected patients, radical surgery still remains the rule when unfavorable pathology occurs. However, there is a risk of undertreating patients not eligible for radical surgery. The aim of this study was to evaluate the outcomes of patients with pathological incomplete response (ypT2) in a multicentre cohort of patients undergoing LE after NT and to compare them with ypT0-is-1 rectal cancers. METHODS: From 2010 to 2019, all patients who underwent LE after NT for rectal cancer were identified from five institutional retrospective databases. After excluding 12 patients with ypT3 tumors, patients with ypT2 tumors were compared to patients with ypT0-is-1 tumors). The endpoints of the study were early postoperative and long-term oncological outcomes. RESULTS: A total of 177 patients (132 males, 45 females, median age 70 [IQR 16] years) underwent LE following NT. There were 46 ypT2 patients (39 males, 7 females, median age 72 [IQR 18.25] years) and 119 ypT0-is-1 patients (83 males, 36 females, median age 69 [IQR 15] years). Patients with pathological incomplete response (ypT2) were frailer than the ypT0-is-1 patients (mean Charlson Comorbidity Index 6.15 ± 2.43 vs. 5.29 ± 1.99; p = 0.02) and there was a significant difference in the type of NT used for the two groups (long- course radiotherapy: 100 (84%) vs. 23 (63%), p = 0.006; short-course radiotherapy: 19 (16%) vs. 17 (37%), p = 0.006). The postoperative rectal bleeding rate (13% vs. 1.7%; p = 0.008), readmission rate (10.9% vs. 0.8%; p = 0.008) and R1 resection rate (8.7% vs. 0; p = 0.008) was significantly higher in the ypT2 group. Recurrence rates were comparable between groups (5% vs. 13%; p = 0.15). Five-year overall survival was 91.3% and 94.9% in the ypT2 and ypT0-is-1 groups, respectively (p = 0.39), while 5-year cancer specific survival was 93.4% in the ypT2 group and 94.9% in the ypT0-is-1 group (p = 0.70). No difference was found in terms of 5-year local recurrence free-survival (p = 0.18) and 5-year distant recurrence free-survival (p = 0.37). CONCLUSIONS: Patients with ypT2 tumors after NT and LE have a higher risk of late-onset rectal bleeding and positive resection margins than patients with complete or near complete response. However, long-term recurrence rates and survival seem comparable.

Rectal Sparing Approach After Neoadjuvant Therapy in Patients with Rectal Cancer: The Preliminary Results of the ReSARCh Trial.

BACKGROUND: Rectum-preservation for locally advanced rectal cancer has been proposed as an alternative to total mesorectal excision (TME) in patients with major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The purpose of this study was to report on the short-term outcomes of ReSARCh (Rectal Sparing Approach after preoperative Radio- and/or Chemotherapy) trial, which is a prospective, multicenter, observational trial that investigated the role of transanal local excision (LE) and watch-and-wait (WW) as integrated approaches after neoadjuvant therapy for rectal cancer. METHODS: Patients with mid-low rectal cancer who achieved mCR or cCR after neoadjuvant therapy and were fit for major surgery were enrolled. Clinical response was evaluated at 8 and 12 weeks after completion of chemoradiotherapy. Treatment approach, incidence, and reasons for subsequent TME were recorded. RESULTS: From 2016 to 2019, 160 patients were enrolled; mCR or cCR at 12 weeks was achieved in 64 and 96 of patients, respectively. Overall, 98 patients were managed with LE and 62 with WW. In the LE group, Clavien-Dindo 3+ complications occurred in three patients. The rate of cCR increased from 8- to 12-week restaging. Thirty-three (94.3%) of 35 patients with cCR had ypT0-1 tumor. At a median 24 months follow-up, a tumor regrowth was found in 15 (24.2%) patients undergoing WW. CONCLUSIONS: LE for patients achieving cCR or mCR is safe. A 12-week interval from chemoradiotherapy completion to LE is correlated with an increased cCR rate. The risk of ypT > is reduced when LE is performed after cCR.

Impact of operation duration on postoperative outcomes of minimally-invasive right colectomy.

AIM: Operation time (OT) is a key operational factor influencing surgical outcomes. The present study aimed to analyse whether OT impacts on short-term outcomes of minimally-invasive right colectomies by assessing the role of surgical approach (robotic [RRC] or laparoscopic right colectomy [LRC]), and type of ileocolic anastomosis (i.e., intracorporal [IA] or extra-corporal anastomosis [EA]). METHODS: This was a retrospective analysis of the Minimally-invasivE surgery for oncological Right ColectomY (MERCY) Study Group database, which included adult patients with nonmetastatic right colon adenocarcinoma operated on by oncological RRC or LRC between January 2014 and December 2020. Univariate and multivariate analyses were used. RESULTS: The study sample was composed of 1549 patients who were divided into three groups according to the OT quartiles: (1) First quartile, <135 min (n = 386); (2) Second and third quartiles, 135-199 min (n = 731); and (3) Fourth quartile ≥200 min (n = 432). The majority (62.7%) were LRC-EA, followed by LRC-IA (24.3%), RRC-IA (11.1%), and RRC-EA (1.9%). Independent predictors of an OT ≥ 200 min included male gender, age, obesity, diabetes, use of indocyanine green fluorescence, and IA confection. An OT ≥ 200 min was significantly associated with an increased risk of postoperative noninfective complications (AOR: 1.56; 95% CI: 1.15-2.13; p = 0.004), whereas the surgical approach and the type of anastomosis had no impact on postoperative morbidity. CONCLUSION: Prolonged OT is independently associated with increased odds of postoperative noninfective complications in oncological minimally-invasive right colectomy.

Cancer risk in adrenalectomy: are adrenal lesions equal or more than 4 cm a contraindication for laparoscopy?

BACKGROUND: Some authors consider adrenal lesions size of less than 4 cm as a positive cut-off limit to set the indications for minimally invasive surgery due to a lower risk of malignancy. Aim of this study is to report the risk of cancer for adrenal lesions measuring 4 cm or more in diameter, assessed as benign at preoperative workup (primary outcome), and to evaluate the feasibility and safety of laparoscopic adrenalectomy (LA) in these cases (secondary outcome). METHODS: From January 1994 to February 2019, 579 patients underwent adrenalectomy. Fifty patients with a preoperative diagnosis of primary adrenal cancer or metastases were excluded. The remaining 529 patients were included and divided in five subgroups based on adrenal lesion size at definitive histology: group A, 4-5.9 cm (137 patients); group B, 6-7.9 cm (64 patients); group C, 8-9.9 cm (13 patients); group D, ≥ 10 cm (11 patients); group E, < 4 cm (304 patients). Each group was further divided based on diagnosis of benign or malignant lesions at definitive histology. RESULTS: Four (2.9%) malignant lesions were observed in group A, 5 (7.8%) in group B, 2 (15.4%) in Groups C and D (18.2%) and 13 (4.3%) in Group E. Comparing the cancer risk among the groups, no statistically significant differences were observed. Operative time increased with increasing lesion size. However, no statistically significant differences were observed between benign and malignant lesions in each group comparing operative time, conversion and complication rates, postoperative hospital stay and mortality rate. CONCLUSIONS: Adrenal lesions measuring 4 cm or more in diameter are not a contraindication for LA neither in terms of cancer risk nor of conversion and morbidity rates, even if the operative time increases with increasing adrenal lesion diameter. Further prospective studies with a larger number of patients are required to draw definitive conclusions.

ERas and COLorectal endoscopic surgery: an Italian society for endoscopic surgery and new technologies (SICE) national report.

BACKGROUND: Several reports demonstrated a strong association between the level of adherence to the protocol and improved clinical outcomes after surgery. However, it is difficult to obtain full adherence to the protocol into clinical practice and has still not been identified the threshold beyond which improved functional results can be reached. METHODS: The ERCOLE (ERas and COLorectal Endoscopic surgery) study was as a cohort, prospective, multi-centre national study evaluating the association between adherence to ERAS items and clinical outcomes after minimally invasive colorectal surgery. The primary endpoint was to associate the percentage of ERAS adherence to functional recovery after minimally invasive colorectal cancer surgery. The secondary endpoints of the study was to validate safety of the ERAS programme evaluating complications' occurrence according to Clavien-Dindo classification and to evaluate the compliance of the Italian surgeons to each ERAS item. RESULTS: 1138 patients were included. Adherence to the ERAS protocol was full only in 101 patients (8.9%), > 75% of the ERAS items in 736 (64.7%) and > 50% in 1127 (99%). Adherence to > 75% was associated with a better functional recovery with 90.2 ± 98.8 vs 95.9 ± 33.4 h (p = 0.003). At difference, full adherence to the ERAS components 91.7 ± 22.1 vs 92.2 ± 31.6 h (p = 0.8) was not associated with better recovery. CONCLUSIONS: Our results were encouraging to affirm that adherence to the ERAS program up to 75% could be considered satisfactory to get the goal. Our study could be considered a call to simplify the ERAS protocol facilitating its penetrance into clinical practice.

Low-pressure versus standard-pressure pneumoperitoneum in laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: It has been previously demonstrated that the rise of intra-abdominal pressures and prolonged exposure to such pressures can produce changes in the cardiovascular and pulmonary dynamic which, though potentially well tolerated in the majority of healthy patients with adequate cardiopulmonary reserve, may be less well tolerated when cardiopulmonary reserve is poor. Nevertheless, theoretically lowering intra-abdominal pressure could reduce the impact of pneumoperitoneum on the blood circulation of intra-abdominal organs as well as cardiopulmonary function. However, the evidence remains weak, and as such, the debate remains unresolved. The aim of this systematic review and meta-analysis was to demonstrate the current knowledge around the effect of pneumoperitoneum at different pressures levels during laparoscopic cholecystectomy. MATERIALS AND METHODS: This systematic review and meta-analysis were reported according to the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines, and the Cochrane handbook for systematic reviews of interventions. RESULTS: This systematic review and meta-analysis included 44 randomized controlled trials that compared different pressures of pneumoperitoneum in the setting of elective laparoscopic cholecystectomy. Length of hospital, conversion rate, and complications rate were not significantly different, whereas statistically significant differences were observed in post-operative pain and analgesic consumption. According to the GRADE criteria, overall quality of evidence was high for intra-operative bile spillage (critical outcome), overall complications (critical outcome), shoulder pain (critical outcome), and overall post-operative pain (critical outcome). Overall quality of evidence was moderate for conversion to open surgery (critical outcome), post-operative pain at 1 day (critical outcome), post-operative pain at 3 days (important outcome), and bleeding (critical outcome). Overall quality of evidence was low for operative time (important outcome), length of hospital stay (important outcome), post-operative pain at 12 h (critical outcome), and was very low for post-operative pain at 1 h (critical outcome), post-operative pain at 4 h (critical outcome), post-operative pain at 8 h (critical outcome), and post-operative pain at 2 days (critical outcome). CONCLUSIONS: This review allowed us to draw conclusive results from the use of low-pressure pneumoperitoneum with an adequate quality of evidence.

Development and validation of a preoperative "difficulty score" for laparoscopic transabdominal adrenalectomy: a multicenter retrospective study.

BACKGROUND: A difficulty score for laparoscopic adrenalectomy (LA) is lacking in the literature. A retrospective cohort study was designed to develop a preoperative "difficulty score" for LA. METHODS: A multicenter study was conducted involving four Italian tertiary centers for adrenal disease. The population was randomly divided into two subsets: training group and validation one. A multicenter study was undertaken, including 964 patients. Patient, adrenal lesion, surgeon's characteristics, and the type of procedure were studied as potential predictors of target events. The operative time (pOT), conversion rate (cLA), or both were used as indicators of the difficulty in three multivariate models. All models were developed in a training cohort (70% of the sample) and validated using 30% of patients. For all models, the ability to predict complicated postoperative course was reported describing the area under the curve (AUCs). Logistic regression, reporting odds ratio (OR) with p-value, was used. RESULTS: In model A, gender (OR 2.04, p = 0.001), BMI (OR 1.07, p = 0.002), previous surgery (OR 1.29, p = 0.048), site (OR 21.8, p < 0.001) and size of the lesion (OR 1.16, p = 0.002), cumulative sum of procedures (OR 0.99, p < 0.001), extended (OR 26.72, p < 0.001) or associated procedures (OR 4.32, p = 0.015) increased the pOT. In model B, ASA (OR 2.86, p = 0.001), lesion size (OR 1.20, p = 0.005), and extended resection (OR 8.85, p = 0.007) increased the cLA risk. Model C had similar results to model A. All scores obtained predicted the target events in validation cohort (OR 1.99, p < 0.001; OR 1.37, p = 0.007; OR 1.70, p < 0.001, score A, B, and C, respectively). The AUCs in predicting complications were 0.740, 0.686, and 0.763 for model A, B, and C, respectively. CONCLUSION: A difficulty score based on both pOT and cLA (Model C) was developed using 70% of the sample. The score was validated using a second cohort. Finally, the score was tested, and its results are able to predict a complicated postoperative course.

Long-Term Outcomes of Local Excision Following Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer.

BACKGROUND: Local excision might represent an alternative to total mesorectal excision for patients with locally advanced rectal cancer who achieve a major or complete clinical response after neoadjuvant chemoradiotherapy. METHODS: Between August 2005 and July 2011, 63 patients with mid-low rectal adenocarcinoma who had a major/complete clinical response after neoadjuvant chemoradiotherapy were enrolled in a multicenter prospective phase 2 trial and underwent transanal full thickness local excision. The main endpoint of this study was to evaluate the 5- and 10-year overall, relapse-free, local, and distant relapse-free survival, which were calculated by applying the Kaplan-Meier method. The rate of patients with rectum preserved and without stoma were also calculated. RESULTS: Of 63 patients, 38 (60%) were male and 25 (40%) were female, with a median (range) age of 64 (25-82) years. At baseline, the following clinical stages were found: cT2, n = 21 (33.3%); cT3, n = 42 (66.6%), 39 (61.9%) patients were cN+. At a median (range) follow-up of 108 (32-166) months, the estimated cumulative 5- and 10-year overall survival, relapse-free survival, local recurrence-free survival, and distant recurrence-free survival were 87% (95% CI 76-93) and 79% (95% CI 66-87), 89% (95% CI 78-94) and 82% (95% CI 66-91), both 91% (95% CI 81-96), and 90% (95% CI 80-95) and 86% (95% CI 73-93), respectively. Overall, 49 (77.8%) patients had their rectum preserved, and 54 (84.1%) were stoma-free. CONCLUSION: In highly selected patients, the local excision approach after neoadjuvant chemoradiotherapy is associated with excellent long-term outcomes, high rates of rectum preservation and absence of permanent stoma.

Patterns of disease detection using [18F]DCFPyL PET/CT imaging in patients with detectable PSA post prostatectomy being considered for salvage radiotherapy: a prospective trial.

PURPOSE: Prostate-specific membrane antigen (PSMA) PET/CT is increasingly used in patients with biochemical recurrence post prostatectomy to detect local recurrence and metastatic disease at low PSA levels. The aim of this study was to assess patterns of disease detection, predictive factors and safety using [18F]DCFPyL PET/CT versus diagnostic CT in patients being considered for salvage radiotherapy with biochemical recurrence post prostatectomy. METHODS: We conducted a prospective trial recruiting 100 patients with detectable PSA post prostatectomy (PSA 0.2-2.0 ng/mL) and referred for salvage radiotherapy from August 2018 to July 2020. All patients underwent a PSMA PET/CT using the [18F]DCFPyL tracer and a diagnostic CT. The detection rates of [18F]DCFPyL PET/CT vs diagnostic CT were compared and patterns of disease are reported. Clinical patient and tumour characteristics were analysed for predictive utility. Thirty-day post-scan safety is reported. RESULTS: Of 100 patients recruited, 98 were suitable for analysis with a median PSA of 0.32 ng/mL. [18F]DCFPyL PET/CT was positive 46.4% and equivocal 5.2%, compared to 15.5% positivity for diagnostic CT. Local recurrence was detected on [18F]DCFPyL PET/CT in 28.5%, nodal disease in 27.5% and bony metastases in 6.1% of patients. Both ISUP grade group (p < 0.001) and pre-scan PSA (p = 0.029) were significant predictors of [18F]DCFPyL PET/CT positivity, and logistic regression generated probabilities combining the two showed improved prediction rates. No significant safety events were reported post [18F]DCFPyL administration. CONCLUSIONS: [18F]DCFPyL PET/CT increases detection of disease in patients with biochemical recurrence post prostatectomy compared to diagnostic CT. Patients being considered for salvage radiotherapy with a PSA >0.2 ng/mL should be considered for [18F]DCFPyL PET/CT scan. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number: ACTRN12618001530213 ( http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375932&isReview=true ).

Laparoscopic transperitoneal adrenalectomy: a comparative study of different techniques for vessel sealing.

BACKGROUND: Laparoscopic adrenalectomy is the standard surgical approach to adrenal lesions. Adrenal vessel sealing is the critical surgical phase of laparoscopic adrenalectomy. This study aimed at comparing perioperative outcomes of laparoscopic transperitoneal adrenalectomy by means of radiofrequency energy-based device (LARFD) to those performed with traditional clipping device (LACD), while focusing on the different adrenal vessel control techniques. METHODS: Patients who underwent adrenalectomy for adrenal disease between January 1994 and April 2019 at the Surgical Clinic, Polytechnic University of Marche were included in the study. Overall, 414 patients met inclusion criteria for study eligibility: 211 and 203 patients underwent LARFD and LACD, respectively. Multiple models of quantile regression, logistic regression and Poisson finite mixture regression were used to assess the relationship between operative time, conversion to open procedure, length of stay (LoS), surgical procedure and patient characteristics, respectively. RESULTS: LARFD reduced operative time of about 12 min compared to LACD. Additional operative time-related factors were surgery side, surgery approach, conversion to open procedure and trocar number. The probability of conversion to open procedure decreased by about 76% for each added trocar, whereas it increased by about 49% for each added centimeter of adrenal lesion and by about 25% for each added year of surgery. Two patient clusters were identified based on the LoS: long-stay and short-stay. In the long-stay cluster, LoS decreased of about 30% in LARFD group and it was significantly associated with conversion to open procedure and postoperative complications, whereas in short-stay cluster only postoperative complications had a significant effect on LoS. CONCLUSION: Laparoscopic transperitoneal adrenalectomy performed by means of radiofrequency energy-based device for the sealing of adrenal vessels is an effective procedure reducing operative time with potentially improved postoperative outcomes.

Current status on the adoption of high energy devices in Italy: An Italian Society for Endoscopic Surgery and New Technologies (SICE) national survey.

BACKGROUND: In the past three decades, different High Energy Devices (HED) have been introduced in surgical practice to improve the efficiency of surgical procedures. HED allow vessel sealing, coagulation and transection as well as an efficient tissue dissection. This survey was designed to verify the current status on the adoption of HED in Italy. METHODS: A survey was conducted across Italian general surgery units. The questionnaire was composed of three sections (general information, elective surgery, emergency surgery) including 44 questions. Only one member per each surgery unit was allowed to complete the questionnaire. For elective procedures, the survey included questions on thyroid surgery, lower and upper GI surgery, proctologic surgery, adrenal gland surgery, pancreatic and hepatobiliary surgery, cholecystectomy, abdominal wall surgery and breast surgery. Appendectomy, cholecystectomy for acute cholecystitis and bowel obstruction due to adhesions were considered for emergency surgery. The list of alternatives for every single question included a percentage category as follows: " < 25%, 25-50%, 51-75% or > 75%", both for open and minimally-invasive surgery. RESULTS: A total of 113 surgical units completed the questionnaire. The reported use of HED was high both in open and minimally-invasive upper and lower GI surgery. Similarly, HED were widely used in minimally-invasive pancreatic and adrenal surgery. The use of HED was wider in minimally-invasive hepatic and biliary tree surgery compared to open surgery, whereas the majority of the respondents reported the use of any type of HED in less than 25% of elective cholecystectomies. HED were only rarely employed also in the majority of emergency open and laparoscopic procedures, including cholecystectomy, appendectomy, and adhesiolysis. Similarly, very few respondents declared to use HED in abdominal wall surgery and proctology. The distribution of the most used type of HED varied among the different surgical interventions. US HED were mostly used in thyroid, upper GI, and adrenal surgery. A relevant use of H-US/RF devices was reported in lower GI, pancreatic, hepatobiliary and breast surgery. RF HED were the preferred choice in proctology. CONCLUSION: HED are extensively used in minimally-invasive elective surgery involving the upper and lower GI tract, liver, pancreas and adrenal gland. Nowadays, reasons for choosing a specific HED in clinical practice rely on several aspects, including surgeon's preference, economic features, and specific drawbacks of the energy employed.

Real-world outcomes for neoadjuvant capecitabine versus infusional 5-fluorouracil in the treatment of locally advanced rectal cancer.

BACKGROUND: Neoadjuvant chemoradiation therapy is standard-of-care treatment for locally advanced rectal cancer (LARC). A pathological complete response (pCR) following chemoradiation therapy is an early indicator of treatment benefit and associated with excellent survival outcomes, with capecitabine largely replacing infusional 5-fluorouracil as the choice in routine care of LARC. AIMS: To analyse the uptake of capecitabine usage over time, and on the back of clinical trial data demonstrating equivalence between fluoropyrimidines, confirm that efficacy is maintained in the real-world setting. METHODS: We analysed data from a prospectively maintained colorectal cancer database at three Australian hospitals including patients diagnosed from January 2009 to December 2018. Pathological response was determined as either complete or incomplete and compared for patients receiving 5-FU or capecitabine. RESULTS: A total of 657 patients was analysed, 498 receiving infusional 5-FU and 159 capecitabine. Capecitabine use has markedly increased from approval in 2014 in Australia, now being used in more than 80% of patients. Patient characteristics were similar by treatment, including age, tumour location and pre-treatment stage. pCR was reported in 22/159 (13.8%) of capecitabine-treated patients and 118/380 (23.7%) that received 5-FU (P ≤ 0.01). More capecitabine-treated patients received post-operative oxaliplatin (44.2% vs 6.3%, P < 0.01). Two-year progression-free survival was similar (84.9% vs 88.0%, P = 0.34). CONCLUSIONS: Capecitabine is now the dominantly used neoadjuvant chemotherapy in LARC. Capecitabine use was associated with a lower rate of pCR versus infusional 5-FU, a difference not explained by examined patient or tumour characteristics. Poor treatment compliance with oral therapy in the real-world setting is one possible explanation.

Are Adrenal Lesions of 6 cm or More in Diameter a Contraindication to Laparoscopic Adrenalectomy? A Case-Control Study.

BACKGROUND: The aim of this case-control study is to compare the surgical outcomes of laparoscopic adrenalectomy (LA) for lesions measuring ≥6 cm versus ≤5.9 cm in diameter. METHODS: Eighty-one patients with adrenal gland lesions ≥6 cm in diameter (intervention group) were identified. Patients were matched to 81 patients with adrenal gland ≤5.9 cm in diameter (control group) based on disease (Conn-Cushing syndrome, pheochromocytoma, primary or secondary adrenal cancer or other disease), lesion side (right, left), surgical technique (anterior transperitoneal approach for right and left LA or anterior transperitoneal submesocolic for left LA) and body mass index class (18-24.9, 25-29.9, 30-34.9, 35-39.9, ≥40 kg/m2). Surgical outcomes were compared between the intervention and control groups. RESULTS: Mean operative time was statistically significantly longer in the interventional arm (101.4 ± 52.4 vs. and 85 ± 31.6 min, p = 0.0174). Eight conversions were observed in the intervention group (9.8%) compared to four in the control group (4.9%) (p = 0.3690). Five (6.1%) and three (3.7%) postoperative complications were observed in the intervention and control groups, respectively (p = 0.7196). Mean postoperative hospital stay was 4.6 ± 2.4 and 4.1 ± 2.3 days in the intervention and control groups, respectively (p = 0.1957). CONCLUSIONS: Operative time was statistically significantly longer in adrenal gland lesions ≥6 cm in diameter (vs. ≤5.9 cm). Conversion and complication rates were also higher, but the difference was not statistically significant. Based on the present data, adrenal gland lesions ≥6 cm in diameter are not an absolute contraindication to the laparoscopic approach.

Is laparoscopic left adrenalectomy with the anterior submesocolic approach for Conn's or Cushing's syndrome equally safe and effective as the lateral and anterior ones?

BACKGROUND: The aim of the present study is to report and to compare the results of three different laparoscopic transperitoneal surgical approaches [lateral transperitoneal (LT), anterior transperitoneal (AT) and anterior transperitoneal submesocolic (ATS)] for the treatment of Conn's and Cushing's syndrome from left adrenal disease. METHODS: This study is a retrospective analysis of prospectively collected data. From 1994 to 2017, 535 laparoscopic adrenalectomies (LA) were performed. One hundred and sixty-four patients with Conn's or Cushing's syndrome underwent left LA. Patients were divided in three groups based on the approach: LT (Group A), AT (Group B) and ATS (Group C). RESULTS: The diagnosis was Conn's and Cushing's syndrome in 99 and 65 patients, respectively. LT was used in 13 cases, AT in 55 and ATS in 96. No significant differences in patient's gender, age and BMI were observed. Mean operative time was 117.6 ± 33.7, 107.6 ± 40.3 and 96.2 ± 47.5 min for Groups A, B and C, respectively. Conversion to open surgery was observed in 4 Group C patients (4.1%). Morbidity occurred in 2 Group B (2%) and in 5 Group C patients (5.2%). CONCLUSIONS: In case of Conn's or Cushing's syndrome, left LA with ATS approach is equally safe and effective as compared to the LT and AT approaches. Early control of the adrenal vein with minimal gland manipulation and limited surgical dissection are the major advantages of the submesocolic approach. Even if statistically significant differences are not observed, postoperative results are the same as those reported in the literature with other approaches.