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Conventional endoscopic resection (CER) is a widely accepted treatment for early colorectal neoplasia; however, large colorectal neoplasias remain problematic, as they necessitate piecemeal resection, increasing the risk of local recurrence. Endoscopic submucosal dissection (ESD) can improve the en bloc resection rate. This study aimed to evaluate local recurrence and its associated risk factors after endoscopic resection (ER) for colorectal neoplasias ≥20 mm. A multicenter prospective study at 18 medium- and high-volume specialized institutions was conducted in Japan. Follow-up colonoscopy was performed after 12 months in cases of complete resection and after 3-6 months in cases of incomplete resection. Local recurrence was confirmed by endoscopic findings and/or pathological analysis. Follow-up colonoscopy was performed in 1,524 of 1,845 enrolled colorectal neoplasias (mean age, 65 years; 885 men; median tumor size, 32.8 mm). The local recurrence rates were 4.3% (65/1,524), 6.8% (55/808), and 1.4% (10/716) for the entire cohort, for CER, and for ESD, respectively. The relative risks of local recurrence were 0.21 (95% confidence interval, 0.11-0.39) with ESD compared with CER, 0.32 (95% confidence interval, 0.11-0.92) with en bloc ESD compared with en bloc CER, and 0.90 (95% confidence interval, 0.39-2.12) with piecemeal ESD compared with piecemeal CER. Significant factors associated with local recurrence were piecemeal resection, laterally spreading tumors of granular type, tumor size ≥40 mm, no pre-treatment magnification, and ≤10 years of experience in CER, and piecemeal resection only in ESD. En bloc ESD reduces the local recurrence rate for large colorectal neoplasias. Piecemeal resection is the most important risk factor for local recurrence regardless of the ER method used.

Background Guidelines remain unclear over whether patients with early stage oral cancer without overt neck disease benefit from upfront elective neck dissection (END), particularly those with the smallest tumours. Methods We conducted a randomised trial of patients with stage T1/T2 N0 disease, who had their mouth tumour resected either with or without END. Data were also collected from a concurrent cohort of patients who had their preferred surgery. Endpoints included overall survival (OS) and disease-free survival (DFS). We conducted a meta-analysis of all six randomised trials. Results Two hundred fifty randomised and 346 observational cohort patients were studied (27 hospitals). Occult neck disease was found in 19.1% (T1) and 34.7% (T2) patients respectively. Five-year intention-to-treat hazard ratios (HR) were: OS HR = 0.71 ( p  = 0.18), and DFS HR = 0.66 ( p  = 0.04). Corresponding per-protocol results were: OS HR = 0.59 ( p  = 0.054), and DFS HR = 0.56 ( p  = 0.007). END was effective for small tumours. END patients experienced more facial/neck nerve damage; QoL was largely unaffected. The observational cohort supported the randomised findings. The meta-analysis produced HR OS 0.64 and DFS 0.54 ( p  < 0.001). Conclusion SEND and the cumulative evidence show that within a generalisable setting oral cancer patients who have an upfront END have a lower risk of death/recurrence, even with small tumours. Clinical Trial Registration NIHR UK Clinical Research Network database ID number: UKCRN 2069 (registered on 17/02/2006), ISCRTN number: 65018995, ClinicalTrials.gov Identifier: NCT00571883.

Background Human papillomavirus-positive oropharyngeal squamous cell carcinoma is increasing in incidence worldwide. Current treatments are associated with high survival rates but often result in significant long-term toxicities. In particular, long-term dysphagia has a negative impact on patient quality of life and health. The aim of PATHOS is to determine whether reducing the intensity of adjuvant treatment after minimally invasive transoral surgery in this favourable prognosis disease will result in better long-term swallowing function whilst maintaining excellent disease-specific survival outcomes. Methods/Design The study is a multicentre phase II/III randomised controlled trial for patients with biopsy-proven Human papillomavirus-positive oropharyngeal squamous cell cancer staged T1-T3 N0-N2b with a primary tumour that is resectable via a transoral approach. Following transoral surgery and neck dissection, patients are allocated into three groups based on pathological risk factors for recurrence. Patients in the low-risk pathology group will receive no adjuvant treatment, as in standard practice. Patients in the intermediate-risk pathology group will be randomised to receive either standard dose post-operative radiotherapy (control) or reduced dose radiotherapy. Patients in the high-risk pathology group will be randomised to receive either post-operative chemoradiotherapy (control) or radiotherapy alone. The primary outcome of the phase II study is patient reported swallowing function measured using the MD Anderson Dysphagia Inventory score at 12 months post-treatment. If the phase II study is successful, PATHOS will proceed to a phase III non-inferiority trial with overall survival as the primary endpoint. Discussion PATHOS is a prospective, randomised trial for Human papillomavirus-positive oropharyngeal cancer, which represents a different disease entity compared with other head and neck cancers. The trial aims to demonstrate that long-term dysphagia can be lessened by reducing the intensity of adjuvant treatment without having a negative impact on clinical outcome. The study will standardise transoral surgery and post-operative intensity-modulated radiotherapy protocols in the UK and develop a gold-standard swallowing assessment panel. An associated planned translational research programme, underpinned by tumour specimens and sequential blood collected as part of PATHOS, will facilitate further empirical understanding of this new disease and its response to treatment. Trial registration This study is registered with ClinicalTrials.gov identifier NCT02215265 .

Background Endoscopic submucosal dissection (ESD) allows en bloc resection of superficial colorectal tumors regardless of size. However, ESD is technically difficult, hazardous, and time consuming. New devices may help overcome these drawbacks. We focused on traction methods and designed a new traction device, the “S–O clip.” Its main advantage is that it allows direct visualization of the cutting line during submucosal dissection. Moreover, it can be used at any location without withdrawing the endoscope. The purpose of this study was to evaluate the efficacy and safety of traction device-assisted ESD for large colorectal tumors using the S–O clip. Methods Between August 2010 and December 2011, ESD was performed in 70 patients with a superficial colorectal tumor ≥20 mm in diameter in our department. Patients were randomized into two groups: 27 cases in the S–O clip-assisted ESD group and 23 cases in the conventional ESD group. Included in the analysis were patient’s gender and age, tumor form, size, and location, rate of en bloc resection, procedure time, presence or absence of intraoperative perforation or delayed bleeding, and pathological findings. Subgroup analysis stratified by these factors and multivariate analyses were conducted. Results In the S–O clip-assisted ESD group, all 27 tumors were resected en bloc without any complications. Although a micro perforation occurred in one patient in the conventional ESD group, further surgical treatment was not required. None of the other 22 cases in the conventional ESD group experienced complications. The mean procedure time for the S–O clip-assisted ESD group was significantly shorter than for the conventional ESD group (37.4 ± 32.6 vs. 67.1 ± 44.1 min, p  = 0.03). No significant between-group differences were found for the other factors. Conclusion Our results demonstrated that S–O clip-assisted ESD is safe and fast for en bloc resection of large superficial colorectal tumors.

Background Surgical management of oral cancer poses significant challenges due to the proximity of critical nerves, like spinal accessory, which increases the risk of inadvertent damage or neuropraxia during surgery. Methods A randomized controlled trial enrolled 32 patients with histologically confirmed oral cavity carcinoma and clinically and radiologically negative cervical neck nodes. Patients were assigned to either level IIb-preserving or conventional selective neck dissection. Shoulder function was evaluated using goniometry, electromyography (EMG), and the Neck Dissection Impairment Index (NDII). Outcomes from these three assessment methods were compared. Results Both groups exhibited impaired spinal accessory nerve function. In the IIb-preserving group, EMG detected impairment in 50% of patients, compared to 95% in the control group. Statistically significant differences were observed between groups across all three assessment methods. However, EMG and goniometry indicated functional recovery at 6 and 12 months, whereas NDII scores remained significantly different at 12 months, despite full nerve recovery observed on EMG and goniometry. Conclusions The study demonstrates agreement between shoulder function measurements (goniometry and EMG) but discordance with NDII. This discrepancy may arise from the distinct constructs used by NDII to assess neck dissection impairment, highlighting potential limitations in its sensitivity to functional recovery.

The CORONIS trial reported differences in short-term maternal morbidity when comparing five pairs of alternative surgical techniques for caesarean section. Here we report outcomes at 3 years follow-up. The CORONIS trial was a pragmatic international 2 × 2 × 2 × 2× 2 non-regular fractional, factorial, unmasked, randomised controlled trial done at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. In this follow-up study, we compared outcomes at 3 years following blunt versus sharp abdominal entry, exteriorisation of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus non-closure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Outcomes included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies. Outcomes were assessed masked to the original trial allocation. This trial is registered with the Current Controlled Trials registry, number ISRCTN31089967. Between Sept 1, 2011, and Sept 30, 2014, 13 153 (84%) women were followed-up for a mean duration of 3·8 years (SD 0·86). For blunt versus sharp abdominal entry there was no evidence of a difference in risk of abdominal hernias (adjusted RR 0·66; 95% CI 0·39–1·11). We also recorded no evidence of a difference in risk of death or serious morbidity of the children born at the time of trial entry (0·99, 0·83–1·17). For exteriorisation of the uterus versus intra-abdominal repair there was no evidence of a difference in risk of infertility (0·91, 0·71–1·18) or of ectopic pregnancy (0·50, 0·15–1·66). For single versus double layer closure of the uterus there was no evidence of a difference in maternal death (0·78, 0·46–1·32) or a composite of pregnancy complications (1·20, 0·75–1·90). For closure versus non-closure of the peritoneum there was no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility (0·80, 0·61–1·06). For chromic catgut versus polyglactin-910 sutures there was no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (3·05, 0·32–29·29). Overall, severe adverse outcomes were uncommon in these settings. Although our study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one technique over another. Other considerations will probably affect clinical practice, such as the time and cost saving of different approaches. UK Medical Research Council and the Department for International Development.

In recent years, human anatomy education has faced challenges with traditional donor dissection, leading to the emergence of virtual dissection as an alternative. This study aims to investigate the academic performance and satisfaction of medical students by comparing the virtual and donor dissections. An open-labeled crossover randomized controlled trial was conducted with 154 first-year medical students in Human Anatomy and Neuroanatomy laboratories, which were divided into three classes. Students were randomly assigned to either the virtual (virtual dissection followed by donor dissection) or donor (donor dissection followed by virtual dissection) groups in each class. A curriculum, incorporating head-mounted displays (HMDs), a life-sized touchscreen, and tablets, was developed. Data was evaluated through quizzes and surveys. In the Human Anatomy laboratory, each class of the donor group conducted heart extraction, dissection and observation. In observation class, the virtual group had a significantly higher mean quiz score than the donor group ( p  < 0.05). Compared to the donor, satisfaction was significantly higher for the HMD (understanding of concept and immersion), life-size touchscreen (esthetics, understanding of the concept, and spatial ability), and tablet (esthetics, understanding of the concept, spatial ability, and continuous use intention). In the Neuroanatomy laboratory, the virtual group showed significantly higher mean quiz scores than the donor group ( p  < 0.05), and tablet showed a significantly higher satisfaction than donor in terms of esthetics, understanding of the concept, and spatial ability. These results suggest that virtual dissection has the potential to supplement or replace donor dissection in anatomy education. This study is innovative in that it successfully delivered scenario-based virtual content and validated the efficacy in academic performance and satisfaction when using virtual devices compared to donor. Trial registration: This research has been registered in the Clinical Research Information Service (CRIS, https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=L&pageSize=10&page=undefined&seq=26002&status=5&seq_group=26002 ) with registration number \"KCT0009075\" and registration date \"27/12/2023\".

Background The weight of surgical radicality, together with a lack of anatomical theoretical basis for surgery and inappropriate practical skills, can lead to serious impairments to bladder, rectal, and sexual functions after laparoscopic excision of deep infiltrating endometriosis. Although the “classical” laparoscopic technique for endometriosis excision involving segmental bowel resection has proven to relieve symptoms successfully, it is hampered by several postoperative long-term and/or definitive pelvic dysfunctions. Methods In this prospective cohort study, we compare the laparoscopic nerve-sparing approach to the classical laparoscopic procedure in a series of 126 cases. Satisfactory data for bowel, bladder, and sexual function were considered as primary endpoints. Results A total of 126 patients were considered for analysis: 61 treated with nerve-sparing radical excision of pelvic endometriosis with segmental bowel resection (group B), and 65 treated with the classical technique (group A). Intraoperative, perioperative, and postoperative complications were similar between the two groups. Mean days of self-catheterization were significantly lower in the nerve-sparing group (39.8 days) compared with the non-nerve-sparing group (121.1 days; p  < 0.001). The relapse rate within 12 months after surgery was comparable between the two groups. Patients of group A suffered from urinary retention more frequently between 1 and 6 months ( p  = 0.035) compared with group B and did not experience any improvement between 6 months and 1 year ( p  = 0.018). Overall detection of severe bladder/rectal/sexual dysfunctions was significantly different between the two groups, and 56 patients of group A (86.2%) reported a significantly higher rate of severe neurologic pelvic dysfunctions vs. 1 patient (1.6%) of group B ( p  < 0.001). Conclusions Our technique appears to be feasible and offers good results in terms of reduced bladder morbidity and apparently higher satisfaction than the classical technique. Considering that this kind of surgery requires uncommon surgical skills and anatomical knowledge, we believe that it should be performed only in selected reference centers.

Background Shoulder dysfunction is common after neck dissection for head and neck cancer (HNC). Brief electrical stimulation (BES) is a novel technique that has been shown to enhance neuronal regeneration after nerve injury by modulating the brain-derived neurotrophic growth factor (BDNF) pathways. The objective of this study was to evaluate the effect of BES on postoperative shoulder function following oncologic neck dissection. Methods Adult participants with a new diagnosis of HNC undergoing Level IIb +/− V neck dissection were recruited. Those in the treatment group received intraoperative BES applied to the spinal accessory nerve (SAN) after completion of neck dissection for 60 min of continuous 20 Hz stimulation at 3-5 V of 0.1 msec balanced biphasic pulses, while those in the control group received no stimulation (NS). The primary outcome measured was the Constant-Murley Shoulder (CMS) Score, comparing changes from baseline to 12 months post-neck dissection. Secondary outcomes included the change in the Neck Dissection Impairment Index (ΔNDII) score and the change in compound muscle action potential amplitude (ΔCMAP) over the same period. Results Fifty-four patients were randomized to the treatment or control group with a 1:1 allocation scheme. No differences in demographics, tumor characteristics, or neck dissection types were found between groups. Significantly lower ΔCMS scores were observed in the BES group at 12 months, indicating better preservation of shoulder function ( p  = 0.007). Only four in the BES group compared to 17 patients in the NS groups saw decreases greater than the minimally important clinical difference (MICD) of the CMS ( p  = 0.023). However, NDII scores ( p  = 0.089) and CMAP amplitudes ( p  = 0.067) between the groups did not reach statistical significance at 12 months. BES participants with Level IIb + V neck dissections had significantly better ΔCMS and ΔCMAP scores at 12 months ( p  = 0.048 and p  = 0.025, respectively). Conclusions Application of BES to the SAN may help reduce impaired shoulder function in patients undergoing oncologic neck dissection, and may be considered a viable adjunct to functional rehabilitation therapies. Trial registration Clinicaltrials.gov ( NCT02268344 , October 17, 2014).