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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.

IntroductionHead and neck cancer (HNC) affects the mouth, throat, salivary glands, voice box, nose or sinuses. Every year, over 12 000 people in the UK are diagnosed with HNC. Neck dissection is a key, surgical component of patient care. However, many people experience postoperative restriction in shoulder and neck movements, pain, fatigue and low mood, with only half ever returning to work.Methods and analysisGetting Recovery Right After Neck Dissection (GRRAND) is a two-arm, multicentre, pragmatic randomised controlled trial. The trial aims to compare clinical and cost-effectiveness of a personalised physiotherapy programme (GRRAND programme) versus usual practice, National Health Service (NHS), postdischarge care.The planned sample size is 390 participants. Participants will be recruited from across UK sites and followed up for 12 months. The primary outcome is the shoulder pain and disability index at 12 months. Economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data, including pain, function, health-related quality of life, mental well-being, health resource use and adverse events, will be collected at 6 weeks, 3, 6 and 12 months, with exercise adherence at 6 weeks. A process evaluation will determine how GRRAND is implemented, delivered and received across clinical settings, exploring what works, for whom and under what conditions. Analysis will be on an intention-to-treat basis and reported inline with the Consolidated Standards of Reporting Trials statement.Ethics and disseminationThe trial was approved by the London-Brent Research Ethics Committee (ref: 24/LO/0722) on 15 October 2024. Trial results will be disseminated via peer-reviewed publications, presentations at national and international conferences, in lay summaries and social media. This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials checklist.Trial registration numberISRCTN13855775.

Although endoscopic submucosal dissection (ESD) is routinely performed under sedation, the difference in ESD performance according to sedation method is not well known. This study attempted to prospectively assess and compare the satisfaction of the endoscopists and patient stability during ESD between two sedation methods. One hundred and fifty-four adult patients scheduled for ESD were sedated by either the IMIE (intermittent midazolam/propofol injection by endoscopist) or CPIA (continuous propofol infusion by anesthesiologist) method. The primary endpoint of this study was to compare the level of satisfaction of the endoscopists between the two groups. The secondary endpoints included level of satisfaction of the patients, patient's pain scores, events interfering with the procedure, incidence of unintended deep sedation, hemodynamic and respiratory events, and ESD outcomes and complications. Level of satisfaction of the endoscopists was significantly higher in the CPIA Group compared to the IMIE group (IMIE vs. CPIA; high satisfaction score; 63.2% vs. 87.2%, P=0.001). The incidence of unintended deep sedation was significantly higher in the IMIE Group compared to the CPIA Group (IMIE vs. CPIA; 17.1% vs. 5.1%, P=0.018) as well as the number of patients showing spontaneous movement or those requiring physical restraint (IMIE vs. CPIA; spontaneous movement; 60.5% vs. 42.3%, P=0.024, physical restraint; 27.6% vs. 10.3%, P=0.006, respectively). In contrast, level of satisfaction of the patients were found to be significantly higher in the IMIE Group (IMIE vs. CPIA; high satisfaction score; 85.5% vs. 67.9%, P=0.027). Pain scores of the patients, hemodynamic and respiratory events, and ESD outcomes and complications were not different between the two groups. Continuous propofol and remifentanil infusion by an anesthesiologist during ESD can increase the satisfaction levels of the endoscopists by providing a more stable state of sedation. ClinicalTrials.gov NCT01806753.

Background Prophylactic central neck dissection in clinically low-risk cT1bT2N0 papillary thyroid carcinoma is controversial, due to a large number of conflicting retrospective studies, some showing an advantage in terms of locoregional recurrence, others showing no advantage. These previous studies all show high rates of excellent response. We aim to demonstrate the non-inferiority of thyroidectomy alone as compared to total thyroidectomy with prophylactic central neck dissection in conjunction with adjuvant RAI 30 mCi with rTSH stimulation in terms of excellent response at 1 year. Trial design and methods Prospective randomized open multicenter phase III trial including patients with 11–40-mm papillary thyroid carcinoma (Bethesda VI) or suspicious cytology (Bethesda V) confirmed malignant on intra-operative frozen section analysis, with no suspicious lymph nodes on a specialized preoperative ultrasound examination. Patients will be randomized 1:1 into two groups: the reference group total thyroidectomy with bilateral prophylactic central neck dissection, and the comparator group total thyroidectomy alone. All patients will receive an ablative dose of 30mCi of radioactive iodine (RAI) within 4 months of surgery. The primary outcome is to compare the rate of excellent response at 1 year after surgery between the groups, as defined by an unstimulated serum thyroglobulin (Tg) level ≤ 0.2 ng/mL with no anti-Tg antibodies, an normal neck ultrasound and no ectopic uptake on the post-RAI scintiscan. Non-inferiority will be demonstrated if the rate of patients with excellent response at 1 year after randomization does not differ by more than 5%. Setting the significance level at 0.025 (one-sided) and a power of 80% requires a sample size of 598 patients (299 per group). Secondary outcomes are to compare Tg levels at 8 +/− 2 postoperative weeks, before RAI ablation, the rate of excellent response at 3 and 5 years, the rate of other responses at 1, 3, and 5 years (biochemical incomplete, indeterminate, and structurally incomplete responses), complications, quality of life, and cost-utility. Discussion (potential implications) If non-inferiority is demonstrated with this high-level evidence, prophylactic neck dissection will have been shown to not be necessary in clinically low-risk papillary thyroid carcinoma. Trial registration NCT 03570021. June 26,2018

BackgroundThe inferior mesenteric artery approach with a selective lateral splenic flexure mobilization is the most widely used initial step in laparoscopic rectal and left colon surgery. Surgery started through the inferior mesenteric vein (IMV) with systematic medial mobilization (MM) has some theoretical advantages that have never been analyzed in a clinical trial. The aim of this study was to compare the two techniques with regards to surgical technique variables (conversion, surgical time, bleeding, morbidity, and mortality) and pathological outcomes.MethodsA single-blinded, randomized, controlled trial of patients operated electively by laparoscopic with curative intention for rectal or sigmoid cancer was performed at a single, specialized colorectal surgery department from April 2016 to October 2017.Results49 patients were included in each group. There were no statistical differences in patient demographics between the two approaches. Pathological outcomes did not differ between the two groups. Intra-operative characteristics showed a higher conversion rate in patients in which the inferior mesenteric artery was dissected first (p = 0.031). The artery approach also increased intra-operative bleeding (p = 0.049), but there were no differences regarding operative time. On multivariate analysis, the artery approach was associated with a higher risk of conversion (OR 8.68; p = 0.050). Post-operatory complications did not differ between artery and vein dissection.ConclusionsIn our study, the initial approach by the IMV with a systematic MM of the splenic flexure has allowed us to reduce the conversion rate without increasing complications or the surgical time. No differences were observed in the pathological results. Both approaches seem to be safe and effective and well-trained laparoscopic surgeons should have the two techniques available to them for use as needed.

Background Endoscopic submucosal dissection (ESD) is widely accepted as a local treatment for gastrointestinal tract tumors. As a simplified endoscopic procedure, hybrid ESD (H-ESD) has been performed for colorectal neoplasms in recent times. However, whether H-ESD is superior to conventional ESD (C-ESD) for patients with early gastric neoplasms (EGN) remains unclear. In this trial, we will compare the treatment outcomes of H-ESD and C-ESD. We hypothesize that the procedure time for H-ESD is shorter than that for C-ESD. Methods This is an investigator-initiated, multi-center, prospective, randomized, open-label, parallel-group trial to be conducted beginning in August 2020 at nine institutions in Japan. We will determine if H-ESD is superior to C-ESD in terms of procedure time in patients with EGN diagnosed as macroscopically intramucosal (T1a) differentiated carcinoma ≤ 20 mm in diameter without ulcerative findings according to current Japanese gastric cancer treatment guidelines. A total of 82 patients will be recruited and randomly assigned to either the C-ESD or the H-ESD group. The primary outcome is ESD procedure time. Secondary outcomes include mucosal incision, time and speed of submucosal dissection, en bloc resection, complete resection, curability, adverse events related to the ESD procedure, extent of dissection before snaring, volume of injection solution, number and time of hemostasis, thickness of the submucosal layer in the resected specimen, and handover to another operator. The stated sample size was determined based on the primary outcome. According to a previous report comparing the procedure times of C-ESD and H-ESD, we hypothesized that H-ESD would provide a 0.2 reduction in logarithmically concerted procedure time (−37%). We estimated that a total of 82 participants were needed to reach a power of 80% for a t -test with a significance level of 0.05 and considering a 10% dropout. Discussion This trial will provide high-quality data on the benefits and risks of H-ESD for EGN patients. The results of this study could lead to improved outcomes in patients with EGN undergoing ESD. The results will be presented at national and international meetings and published in peer-reviewed journals. Trial registration UMIN-CTR UMIN000041244 . Registered on July 29, 2020.

Background Esophageal stenosis following endoscopic submucosal dissection (ESD) is a serious adverse event that makes subsequent management more difficult. Methods This parallel, randomized, controlled, open-label study was designed to examine whether local steroid injection is an effective prophylactic treatment for esophageal stenoses following extensive ESD. This single center trial was conducted at the Keiyukai Hospital, a tertiary care center for gastrointestinal disease in Japan [University Hospital Medical Network Clinical Trial Registry (UMIN-CTR) on 15 September 2011 (UMIN000006327)]. Thirty-two patients with mucosal defects involving ≥75% of the esophageal circumference were randomized to receive a single dose of triamcinolone acetonide injections (n = 16) or be treated conventionally (n = 16). The primary outcome was the frequency of stricture requiring endoscopic dilatation; the surrogate primary endpoint was the number of dilatation sessions needed. Secondary outcomes included adverse event rates, the minimum diameter of the stenotic area and the duration of the course of dilatation treatments. Results The frequency of stricture was not significantly different between the groups because of insufficient statistical power, but the number of dilatation sessions required was significantly less in the steroid group (6.1 sessions [95% confidence interval, CI 2.8–9.4] versus 12.5 [95% CI 7.1–17.9] sessions in the control group; P  = 0.04). The perforation rate was similar in both groups. The minimum diameter of stenotic lumens was significantly greater in the treatment group than controls (11.0 mm versus 7.1 mm, respectively; P  = 0.01). The perforation rate was not significantly different between the groups (1.0% versus 0.5% in the treatment and control group, respectively). Steroid injection was effective in cases of mucosal defects encompassing the entire esophageal circumference. Conclusions Prophylactic endoscopic steroid injection appears to be a safe means of relieving the severity of esophageal stenoses following extensive ESD.

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).

Background The lymphatic spread from the cancers of the oral cavity follows an orderly progression and involvement of lower nodes without involvement of upper nodes and skip metastasis is rare. Selective neck dissections are increasingly being performed for node-positive patients; however, in node-negative patients the options of wait and watch, prophylactic radiotherapy, and prophylactic elective node dissections are debated. Quality of life and shoulder functions are important to choose the appropriate therapeutic modality. Patients and methods Patients with oral squamous carcinoma with clinically and radiologically negative neck were randomized to IIb preserving superselective neck dissection or conventional supraomohyoid neck dissection. The primary end point of the study was recurrence of disease (clinical or radiological) and shoulder function as demonstrated by the clinical examination and electromyography. The secondary end point was quality of life as measured by the FACT-HN version 4 questionnaire at the end of 1 year follow-up. Results The mean number of lymph node harvested per patient was 25.6 (range 8–85). Of the 32 patients, 3 had histologically positive node in level Ib, one of these patients had single positive node while the remaining two had three positive nodes in level Ib. At median follow-up of 36 months disease-free survival in IIb, sparing group was 83% compared to 91% in control arm, the difference in survival between two groups was statistically not significant ( p  = 0.694). EMG of the shoulder showed denervation pattern in 45% patients undergoing IIb preserving surgery at 1 month follow-up compared to 95% in conventional surgery group, this recovered in all patients but one at 3 months and 100% recovery was seen at 6 months. Conclusions The results of the present study indicate that superselective IIb preserving neck dissections are technically feasible and appear to be oncologically safe procedures when performed as elective prophylactic procedures in highly select group of patients. A significant number of occult metastasis seen in the present study suggests prophylactic dissection to be better than wait and watch policy. Results also show initial higher shoulder morbidity at 1 month in patients undergoing IIb preserving dissections; however, at the end of 1 year recovery is complete and both procedures are comparable. Trial registration The trial is registered at clinicaltrials.gov with registration no NCT00847717 ; registered on February 19, 2009.

Background Prophylactic central lymph node dissection (PCND) was a basic consensus for patients with papillary thyroid carcinoma (PTC) in China. However, unilateral or bilateral central lymph node dissection (CND) was still controversial. This study aimed at investigating the safety and long-term benefit for the patients undergone with bilateral central lymph node dissection (BCCD). Methods 581 patients were enrolled and divided randomly into the test and control groups according to range of CND. 285 patients were prospectively assigned to undergo thyroid lobectomy plus BCND in the test group, other 296 patients were assigned to undergo thyroid lobectomy plus ipsilateral central lymph node dissection (ICND) in the control group. Results We found that the numbers of total LN and pN1a in the test group were more than that of the control group ( p  = 0.002,0.004), but there was no difference in the number of metastasized lymph nodes ( p  = 0.857) and tumor recurrence ( p  = 0.308). Additionally, in the aspect of postoperative complication (1 day after surgery), the serum levels of parathyroid hormone in the BCND group were lower than that in the ICND group ( P  = 0.010), and the numbers of transient laryngeal nerve palsy were more than that( p  = 0.033). Meanwhile, we further found that pathological tumor size larger than 1 cm and tumor side lymph node metastasis were independent risk factors for contralateral central lymph node metastasis( p  = 0.002,0.001). Conclusion BCND may be an alternative for patients with tumor sizes larger than 1 cm, but it would significantly increase the rate of transient vocal cord palsy, parathyroid auto transplantation and decreased PTH, but the risk of permanent complications was similar to the ICND group.