Natural orifice specimen extraction surgery versus small-incision assisted laparoscopic radical right hemicolectomy.

Conventional laparoscopic-assisted right hemicolectomy requires a small abdominal incision to extract the specimen, which becomes an important source of postoperative complications and impairs perioperative experience. Transvaginal natural orifice specimen extraction surgery (NOSES VIIIA) avoids this small incision by extracting the specimen through the vagina. Here we describe the design of a multicenter, open-label, parallel, noninferior, phase III randomized controlled trial (NCT05495048). The aim of this study is to confirm that the NOSES VIIIA procedure is not inferior to small-incision assisted right hemicolectomy in long-term oncological efficacy. A total of 352 female patients with right colon adenocarcinoma/high-grade intraepithelial neoplasia will be randomly assigned to the NOSES VIIIA arm and the small-incision arm in a 1:1 ratio. The primary end point of this trial is 3 year disease-free survival. Clinical Trial Registration: NCT05495048 (ClinicalTrials.gov).

Effectiveness of Hemopatch® versus Surgicel® Original to control mild and moderate liver bleeding.

BACKGROUND: Adjunct hemostats can be of use in certain surgical settings. We compared the effectiveness of two hemostats, Hemopatch® and Surgicel® Original in controlling bleeding from liver lesions in an experimental model. METHODS: Control of grades 1 (mild) and 2 (moderate) bleeding (according to the Validated Intraoperative Bleeding [VIBe] SCALE) was assessed for 10 min after Hemopatch® (n = 198) or Surgicel® Original (n = 199) application on 397 liver surface lesions. The primary endpoint was hemostatic success (reaching VIBe SCALE grade 0 at 10 min). The secondary endpoint was time to hemostasis (time to reach and maintain grade 0). A generalized linear mixed model and an accelerated failure time model were used to assess the primary and secondary endpoints, respectively. RESULTS: The overall hemostatic success rate of Hemopatch® was statistically significantly superior to that of Surgicel® Original (83.8% versus 73.4%; p = 0.0036; odds ratio [OR] 2.38, 95% confidence interval [CI] 1.33-4.27) and time to hemostasis was reduced by 15.9% (p = 0.0032; 95% CI 0.749-0.944). Grade 2 bleeds treated with Hemopatch® had statistically significantly higher hemostatic success (71.7% versus 48.5%; p = 0.0007; OR 2.97, 95% CI 1.58-5.58) and shorter time to hemostasis (49.6% reduction, p = 3.6 × 10-8); differences for grade 1 bleeds (hemostatic success rate or time to hemostasis) were not statistically significant. CONCLUSIONS: Hemopatch® provided better control of VIBe SCALE bleeding compared to Surgicel® Original for Grade 2 bleeds in this porcine model, highlighting the importance of choosing a suitable hemostat to optimize control of bleeding during surgery.

p-Value: Villain or Scapegoat?

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Superior mesenteric-portal vein resection during laparoscopic pancreatoduodenectomy.

BACKGROUND: Laparoscopic pancreatoduodenectomy (LPD) with concomitant resection of major portal vessels has recently emerged as feasible and safe, with similar morbidity and mortality as well as oncologic outcome compared with patients undergoing open PD with major vascular resection. MATERIALS AND METHODS: Of a consecutive series of 133 LPD, eight patients underwent concomitant superior mesenteric vein/portal vein (SMV/PV) resection and reconstruction with the intent of achieving a R0 resection. RESULTS: Four of these eight patients had tangential resection followed by lateral wall repair with Prolene 4.0. One patient had tangential resection with patch reconstruction. Three patients had circular venous resection: One had end-to-end primary venous reconstruction, and two patients had a prosthetic vascular graft interposition. There was no operative mortality. The SMV/PV was patent in all patients postoperatively on ultrasound Doppler or CT scans. Two patients (who underwent circular venous resection) had postoperative complications. One 77-year-old patient with preexisting cardiovascular disease died of heart failure on postoperative day 2, while another (undergoing prosthetic graft reconstruction) had postoperative bilioenteric anastomotic dehiscence and underwent immediate re-laparoscopy for repair. CONCLUSIONS: In our experience, LPD with concomitant major venous resection is feasible even in cases of longitudinal venous invasion. Further studies are needed to evaluate the role of laparoscopy in borderline pancreatic cancer.

Interaction analysis of subgroup effects in randomized trials: the essential methodological points.

Subgroup analysis aims to identify subgroups (usually defined by baseline/demographic characteristics), who would (or not) benefit from an intervention under specific conditions. Often performed post hoc (not pre-specified in the protocol), subgroup analyses are prone to elevated type I error due to multiple testing, inadequate power, and inappropriate statistical interpretation. Aside from the well-known Bonferroni correction, subgroup treatment interaction tests can provide useful information to support the hypothesis. Using data from a previously published randomized trial where a p value of 0.015 was found for the comparison between standard and Hemopatch® groups in (the subgroup of) 135 patients who had hand-sewn pancreatic stump closure we first sought to determine whether there was interaction between the number and proportion of the dependent event of interest (POPF) among the subgroup population (patients with hand-sewn stump closure and use of Hemopatch®), Next, we calculated the relative excess risk due to interaction (RERI) and the "attributable proportion" (AP). The p value of the interaction was p = 0.034, the RERI was - 0.77 (p = 0.0204) (the probability of POPF was 0.77 because of the interaction), the RERI was 13% (patients are 13% less likely to sustain POPF because of the interaction), and the AP was - 0.616 (61.6% of patients who did not develop POPF did so because of the interaction). Although no causality can be implied, Hemopatch® may potentially decrease the POPF after distal pancreatectomy when the stump is closed hand-sewn. The hypothesis generated by our subgroup analysis requires confirmation by a specific, randomized trial, including only patients undergoing hand-sewn closure of the pancreatic stump after distal pancreatectomy.Trial registration: INS-621000-0760.

Magnetic resonance imaging-based deep learning model to predict multiple firings in double-stapled colorectal anastomosis.

BACKGROUND: Multiple linear stapler firings during double stapling technique (DST) after laparoscopic low anterior resection (LAR) are associated with an increased risk of anastomotic leakage (AL). However, it is difficult to predict preoperatively the need for multiple linear stapler cartridges during DST anastomosis. AIM: To develop a deep learning model to predict multiple firings during DST anastomosis based on pelvic magnetic resonance imaging (MRI). METHODS: We collected 9476 MR images from 328 mid-low rectal cancer patients undergoing LAR with DST anastomosis, which were randomly divided into a training set (n = 260) and testing set (n = 68). Binary logistic regression was adopted to create a clinical model using six factors. The sequence of fast spin-echo T2-weighted MRI of the entire pelvis was segmented and analyzed. Pure-image and clinical-image integrated deep learning models were constructed using the mask region-based convolutional neural network segmentation tool and three-dimensional convolutional networks. Sensitivity, specificity, accuracy, positive predictive value (PPV), and area under the receiver operating characteristic curve (AUC) was calculated for each model. RESULTS: The prevalence of ≥ 3 linear stapler cartridges was 17.7% (58/328). The prevalence of AL was statistically significantly higher in patients with ≥ 3 cartridges compared to those with ≤ 2 cartridges (25.0% vs 11.8%, P = 0.018). Preoperative carcinoembryonic antigen level > 5 ng/mL (OR = 2.11, 95%CI 1.08-4.12, P = 0.028) and tumor size ≥ 5 cm (OR = 3.57, 95%CI 1.61-7.89, P = 0.002) were recognized as independent risk factors for use of ≥ 3 linear stapler cartridges. Diagnostic performance was better with the integrated model (accuracy = 94.1%, PPV = 87.5%, and AUC = 0.88) compared with the clinical model (accuracy = 86.7%, PPV = 38.9%, and AUC = 0.72) and the image model (accuracy = 91.2%, PPV = 83.3%, and AUC = 0.81). CONCLUSION: MRI-based deep learning model can predict the use of ≥ 3 linear stapler cartridges during DST anastomosis in laparoscopic LAR surgery. This model might help determine the best anastomosis strategy by avoiding DST when there is a high probability of the need for ≥ 3 linear stapler cartridges.

Pathological and perioperative outcomes of extracorporeal versus intracorporeal anastomosis in laparoscopic transverse colon cancer resection: retrospective multicentre study.

BACKGROUND: The aim of this study was to compare the pathological and perioperative outcomes of extracorporeal versus intracorporeal anastomosis after laparoscopic transverse colon cancer resection. METHODS: In this retrospective study, patients from seven institutions in China who underwent laparoscopic resection of transverse colon cancer between 2019 and 2021 were selected and included. Either extended right hemicolectomy or transverse colectomy/extended left hemicolectomy was performed. The clinical characteristics and the pathological and perioperative outcomes were compared between patients undergoing extracorporeal or intracorporeal anastomosis. Resection margin lengths were measured on formalin-fixed specimens and an inadequate margin was defined as less than 4.2 cm between the division and the tumour. The outcome of interest was the prevalence of specimens with an inadequate margin. Length of incision, bowel function recovery, hospital stay, early postoperative pain (first day after surgery), 30-day complications, and nodal harvest were investigated as secondary outcomes. RESULTS: Of 411 patients treated during the study interval, 370 patients with transverse colon cancer were included (23.2 per cent treated with intracorporeal anastomosis and 76.8 per cent treated with extracorporeal anastomosis). The prevalence of specimens with inadequate margins was lower in the intracorporeal anastomosis group compared with the extracorporeal anastomosis group in patients undergoing extended right hemicolectomy (P = 0.045) and in patients undergoing transverse colectomy/extended left hemicolectomy (P = 0.030). In multivariate analysis, extracorporeal anastomosis (OR 2.94 (95 per cent c.i. 1.33 to 6.49), P = 0.008) and transverse colectomy/extended left hemicolectomy (OR 1.75 (95 per cent c.i. 1.03 to 2.96), P = 0.038) were independent risk factors for specimens with an inadequate margin. Intracorporeal anastomosis was associated with a shorter incision length (P < 0.001), an earlier recovery of bowel function (P = 0.035), a shorter postoperative hospital stay (P = 0.042), less early postoperative pain (P < 0.001), a longer specimen length (P = 0.042), a longer resection margin (P = 0.007), and a greater lymph node harvest (P = 0.036). There was no statistically significant difference in 30-day complications. CONCLUSION: Patients with transverse colon cancer have better perioperative outcomes, fewer margins of less than 4.2 cm, and larger lymph node harvests when the anastomosis is performed intracorporeally. Further studies are needed to confirm these findings. REGISTRATION NUMBER: NCT05061199 (www.clinicaltrials.gov).

Role of perioperative nutritional status and enteral nutrition in predicting and preventing post-operative complications in patients with Crohn's disease.

Background: Perioperative immune-nutritional status is correlated with post-operative outcomes. This study aimed to evaluate whether pre-operative nutritional status could predict post-operative complications in patients with Crohn's disease (CD) and whether pre-operative enteral nutrition (EN) can prevent post-operative complications. Methods: This retrospective cohort study analyzed the electronic health records of 173 patients diagnosed with CD in Ruijin Hospital, Shanghai, China, between August 2015 and May 2021: 122 patients had pre-operative nutritional support while 51 patients underwent surgery without pre-operative nutritional support. The pre-operative nutritional status, disease activity index, disease-related data, frequency of multiple surgery, operative data, and post-operative characters in each group were compared to determine whether the nutritional support and status could significantly affect post-operative outcome. One-to-one propensity score matching (PSM) was performed to limit demographic inequalities between the two groups. Results: After PSM, no statistically significant differences were found in pre-operative patient basic characteristics between the two groups of 47 patients (98 patients in all) included in this study. Overall, 21 patients developed 26 post-operative complications. In terms of pre-operative nutritional status, the level of serum albumin (ALB), pre-albumin (pre-ALB), and hemoglobin (Hb) in the nutrition group were statistically higher than that in the control group. We also observed a statistically significant decrease in post-operative complications, need for emergency surgery, and staged operations, while the rate of laparoscopic surgery was higher in the nutrition group compared to the non-nutritional group. Post-operative complications were related to pre-operative nutritional condition, which indicated that EN may improve the nutritional status and reduced the rate of post-operative complications. Conclusion: Pre-operative nutritional status is correlated with post-operative outcomes while EN plays a positive role in preventing the post-operative complications. EN is useful for improving the pre-operative nutritional status and reducing the post-operative adverse events for CD patients undergoing surgery.

Academic surgery amid the COVID-19 pandemic: A perspective of the present and future challenges.

This narrative review describes the trials and tribulations of academic surgeons in four major cities of their respective countries and the solutions they retained to keep academia alive in their practice. The four pillars of an "academic surgeon" _teaching, producing scientific works presented in meetings, publications and research_ are dealt with bearing in mind the modifications brought about by the pandemic and the solutions to keep academia active. Throughout the pandemic, the ultimate goal has been and will be to improve care and train the next generation of surgeons and encourage and monitor researchers, guide the mentees through the tasks of leadership, and foster good sound presentations at scientific meetings and encourage innovative and fruitful publications. The pros and cons of the alternatives imposed by the pandemic for the above-mentioned academic components, based on the literature, are reviewed and analyzed as they are taking place today in Shanghai, Milan, Graz, TaiChung and Hsinchu. Our perspective for the future is that teaching will take a new aspect and make wide use of electronic platforms, but also, the face-to-face modality will surface again. According to local needs and funding, many will most likely choose the hybrid solution (electronic and presential). Production of scientific works in meetings has gained momentum, again with the hybrid solution being preferred. Scientific publications have already increased on topics that are no longer related to COVID-19, and both clinical and experimental research are flourishing. This review can provide insight to guide young and accomplished academic surgeons through these difficult times and beyond, promoting a renaissance of clinical research and relevant publications, teaching of surgery and scientific meetings with a hybrid approach, and, finally, contribute to the training and formation of a new generation of surgeons for the future post-COVID-19 era.

Safety and feasibility of laparoscopic surgery for colorectal and gastric cancer under the Chinese multi-site practice policy: admittance standards of competence are needed.

Background: The multi-site practice (MSP) policy has been practiced in China over 10 years. This study aimed to investigate the safety and feasibility of performing laparoscopic surgery for colorectal cancer (LSCRC) and gastric cancer (LSGC) under the Chinese MSP policy. Methods: We collected and analysed the data from 1,081 patients who underwent LSCRC or LSGC performed by one gastrointestinal surgeon in his original hospital (n = 573) and his MSP institutions (n = 508) between January 2017 and December 2020. Baseline demographics, intraoperative outcomes, post-operative recovery, and pathological results were compared between the original hospital and MSP institutions, as well as between MSP institutions with and without specific competence (surgical skill, operative instrument, perioperative multi-discipline team). Results: In our study, 690 patients underwent LSCRC and 391 patients underwent LSGC. The prevalence of post-operative complications was comparable for LSCRC (11.5% vs 11.1%, P = 0.89) or LSGC (15.2% vs 12.6%, P = 0.46) between the original hospital and MSP institutions. However, patients in MSP institutions without qualified surgical assistant(s) and adequate instruments experienced longer operative time and greater intraoperative blood loss. The proportion of patients with inadequate lymph-node yield was significantly higher in MSP institutions than in the original hospital for both LSCRC (11.5% vs 21.2%, P < 0.01) and LSGC (9.8% vs 20.5%, P < 0.01). Conclusion: For an experienced gastrointestinal surgeon, performing LSCRC and LSGC outside his original hospital under the MSP policy is safe and feasible, but relies on the precondition that the MSP institutions are equipped with qualified surgical skills, adequate operative instruments, and complete perioperative management.

Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial.

Introduction: Postoperative pancreatic fistula (POPF) is the most dreaded complication after distal pancreatectomy (DP). This multicenter randomized trial evaluated the efficacy, safety, and tolerance of Hemopatch in preventing clinically relevant (grades B/C according to the ISGPS classification) POPF after DP. Material and methods: After stump closure, patients were randomized to affix Hemopatch to the stump or not. Statistical significance was set at 0.025. Clinical significance was defined as the number of patients needed to treat (NNT) to avoid 1 B/C POPF. Results: Of 631 eligible patients, 360 were randomized and 315 analyzed per protocol (155 in the standard closure group; 160 in the Hemopatch group). The rates of B/C POPF (the primary endpoint) were 23.2% and 16.3% (P = 0.120), while the number of patients with 1 or more complications (including patients with B/C POPF) was 34.8% and 24.4% (P = 0.049) in the standard and Hemopatch groups, respectively. In patients with hand-sewn stump and main duct closure, the rates were 26.2% versus 10.0% (P = 0.014) and 23.3% versus 7.7% (P = 0.015) in the standard and Hemopatch groups, respectively. The NNT in these 2 subgroups was 6 and 6.4, respectively. Conclusion: The results of the first randomized trial evaluating Hemopatch-reinforced pancreatic stump after DP to prevent type B/C POPF do not allow us to conclude that the risk of B/C POPF was lower. Based on the NNT, however, routine use of Hemopatch after DP may result in fewer complications (including POPF) overall, especially in cases with hand-sewn closure of the pancreatic stump or main pancreatic duct.

Microsatellite Status Affects Tumor Response and Survival in Patients Undergoing Neoadjuvant Chemotherapy for Clinical Stage III Gastric Cancer.

BACKGROUND: We assessed the association between microsatellite instability-high (MSI-H) and tumor response to neoadjuvant chemotherapy (NAC) as well as its prognostic relevance in patients with clinical stage III gastric cancer (cStage III GC). MATERIALS AND METHODS: The NAC + surgery and the control cohorts consisted of 177 and 513 cStage III GC patients, respectively. The clinical and pathological features were compared between patients with MSI-H [n=57 (8.3%)] and microsatellite stability or microsatellite instability-low (MSS/MSI-L) [n=633 (91.7%)]. Radiological and histological response to NAC were evaluated based on response evaluation criteria in solid tumors (RECIST) and tumor regression grade (TRG) systems, respectively. The log-rank test and Cox analysis were used to determine the survival associated with MSI status as well as tumor regression between the two groups in both NAC + surgery and the control cohorts. RESULTS: A statistically significant association was found between MSI-H and poor histological response to NAC (p=0.038). Significant survival priority of responders over poor-responders could only be observed in MSS/MSI-L but not in MSI-H tumors. However, patients with MSI-H had statistically significantly better survival compared to patients with MSS/MSI-L in both the NAC + surgery (hazard ratio=0.125, 95% CI, 0.017-0.897, p=0.037 ) and the control cohort (hazard ratio=0.479, 95% CI, 0.268-0.856, p=0.013). CONCLUSION: MSI-H was associated with poorer regression and better survival after NAC for cStage III GC. TRG evaluation had prognostic significance in MSS/MSI-L but not in MSI-H. Further studies are needed to assess the value of NAC for cStage III GC patients with MSI-H phenotype.