Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.

Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.

The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).

The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.

Trial registration number: COMET registration number 3485

Shared decision-making is widely advocated in policy and practice, but how it is to be applied in a high-stakes clinical decision such as major lower limb amputation due to chronic limb-threatening ischaemia or diabetic foot is unclear. The aim of this study was to explore the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.

A qualitative study (done as part of a broader mixed-methods study) using semi-structured interviews. Interview transcriptions were analysed using thematic analysis.

Vascular centres in three large National Health Service hospitals in Wales and England, UK, between 1 October 2020 and 30 September 2022.

A purposive sample of 18 patients for whom major lower limb amputation was considered as a treatment option/carried out, with interviews conducted before or within 4 months of amputation and 4–6 months after amputation. A further purposive sample of 20 healthcare professionals (including eight surgeons) involved in supporting or conducting major lower limb amputation decision-making.

Five major categories were identified that highlighted the challenges of ensuring shared decision-making associated with major lower limb amputation: (i) patients’ limited understanding, (ii) variable patient attitudes to decision-making, (iii) healthcare professionals’ perceived challenges to sharing decision-making, (iv) surgeons’ paternalism and (v) patients’ and healthcare professionals’ decisional regret/possible consequences of challenges.

Amputation is a life-changing decision for both patients and healthcare professionals, with huge consequences. Despite being considered the gold standard, our findings highlight several challenges to effective shared decision-making for major lower limb amputation. Shared decision-making training for healthcare professionals is paramount if these limitations are to be addressed and patients are to feel confident in being adequately informed about the treatment decisions that they make.

NCT04903756.

To determine the time intervals between injury and orthopaedic admission, admission and surgery, and postsurgery length of stay and to elucidate factors contributing to delays in accessing orthopaedic services.

Prospective cohort study.

A tertiary hospital in the rural Eastern Cape province of South Africa.

413 adult patients admitted with femur fractures between January 2024 and July 2024.

The primary outcome was the time interval from injury to surgical fixation. Secondary outcomes included time from admission to surgery, length of hospital stay and reasons for delays.

Of 413 patients, only 22% (n=91) received surgical intervention within 48 hours of admission. The median time from injury to admission was 4 days (IQR 0–12), and injury to surgery was 13 days (IQR 0–713). Systemic factors, including limited theatre capacity and bed shortages, were the main reasons for delays. In the multivariate analysis, cardiac disease (adjusted OR, AOR=9.62), diabetes mellitus (AOR=4.36) and a Glasgow Coma Scale score of

Significant delays in femoral fracture fixation were observed, with fewer than 10% receiving surgery within 48 hours of injury. Addressing surgical capacity and referral pathways is essential to improving timely access to care.

This study aimed to investigate the burden and characteristics of revision total hip arthroplasty (THA) in China.

A national retrospective study was conducted based on the Hospital Quality Monitoring System (HQMS) in China. Patients who underwent revision total hip arthroplasty (THA) between 2013 and 2018 were included. Revision burden was calculated as the ratio of revision procedures to the total number of THA procedures. Demographic and hospital characteristics, hospitalisation charges, clinical indications and patient migration patterns related to revision THA were analysed.

Tertiary hospitals across China.

A total of 13 029 revision THA cases from HQMS.

Revision burden, indications for revision, hospitalisation charges, hospital level, patient migration and their trend.

During the study period, 13 029 revision THA cases were identified. The revision burden showed an increasing trend from 2013 to 2018 (4.5% to 5.4%; p for trend=0.002). The hospitalisation charges continued to increase between 2013 and 2016 and decreased over the next 2 years. The leading indications for revision THA were prosthesis loosening (44.0%), prosthesis dysfunction (13.7%) and fracture (10.7%). More than 60% of patients were hospitalised in provincial hospitals, but this proportion gradually decreased over time. 14.8% of patients were hospitalised in a hospital outside the province of their residence. Shanghai and Beijing were the most preferred migration destinations, with 63.5% and 52.0% of patients from outside provinces, respectively.

This study provided epidemiological data on revision THA in China based on a national database. During the study period, there was an increasing trend in the revision burden, and hospitalisation costs shifted from an annual increase to a decrease. China exhibits distinct characteristics regarding indications for revision THA. Additionally, significant regional disparities in revision THA were evident, leading to a considerable phenomenon of migration.

Although timely surgery is essential for improving general health and psychosocial outcomes, delays in cleft surgery remain common in low- and middle-income countries, including Rwanda, where little is known about the underlying causes. This study aimed to explore the factors influencing delays in cleft surgery in Rwanda using the four-delay framework.

A phenomenological qualitative study was conducted between April and July 2024. We conducted 29 in-depth interviews with 15 caregivers of children with orofacial clefts and 14 healthcare providers involved in cleft care. Transcripts were analysed thematically using an inductive–deductive hybrid approach in MAXQDA (V.24), guided by the four-delay framework while allowing themes to emerge from the data.

This qualitative study was conducted across six Operation Smile-supported hospitals in Rwanda. Operation Smile is a non-governmental organisation providing cleft care in several low- and middle-income countries, including Rwanda. Among these facilities, one is a tertiary-level hospital located in Kigali city, while the others are secondary-level hospitals distributed across all provinces of the country.

Participants were purposively selected and comprised caregivers of children who underwent cleft surgery at Operation Smile-supported hospitals between 2023 and 2024, as well as healthcare providers with a minimum of 6 months’ experience delivering cleft care at these facilities.

Six major themes and 15 subthemes emerged. Limited caregiver awareness, cultural beliefs and inconsistent knowledge of clefts among healthcare providers influenced delays in seeking care. Reaching care was impeded by long distances, poor road infrastructure and inadequate transportation options. Receiving care was delayed by patient-related factors such as poor nutritional status of children and systemic issues, including shortages of specialised cleft care workforce (such as plastic surgeons, oral and maxillofacial surgeons, anaesthesiologists, etc) and surgical infrastructure. Remaining in care was affected by the absence of multidisciplinary follow-up services. Despite these barriers, caregivers appreciated the support services provided by Operation Smile, including nutrition, transportation and coverage of surgery costs.

Cleft surgery delays in Rwanda are driven by multifactorial barriers across all stages of care. Strengthening early identification, public awareness, health provider training and post-operative support systems is essential to reducing delays and improving outcomes. Findings support the need for integrated cleft care within national surgical plans and broader health system strengthening efforts, and encourage the social and psychological support to affected children and caregivers.

Complex breast surgery, including immediate breast reconstruction and oncoplastic procedures, is increasingly performed to optimise oncologic and aesthetic outcomes. Postoperative wound healing complications remain a major concern, particularly in high-risk patients. Negative pressure wound therapy (NPWT) has been shown to improve wound healing in various surgical fields. However, its effectiveness in oncologic breast surgery remains insufficiently studied. This study aims to evaluate the efficacy of NPWT in reducing wound healing complications in complex breast cancer surgery.

The TPN-SEIN study is a prospective, randomised, controlled, open-label, multicentre, phase III clinical trial. A total of 254 patients undergoing complex breast cancer surgery will be randomised either to arm 1 (NPWT immediately postoperatively for 7 days) or arm 2 (standard wound care). The primary endpoint is the rate of wound healing complications at day 30, defined as at least one of the following: deep postoperative infection of the prosthetic pocket, wound dehiscence or incomplete healing. Secondary endpoints include surgical site infection at day 90, reoperation rate, hospital readmission rate, time to complete healing, time to adjuvant treatment initiation, quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire and breast cancer-specific quality of life questionnaire (QLQ-C30)), patient satisfaction and medico-economic outcomes.

The study was approved by the French national ethics committee (Comité de Protection des Personnes Est II, 5 December 2024, reference 24.04416.000295) and the institutional review board (IRB–COMERE, reference ICM-RCM 2024/11). The French National Agency for the Safety of Health Products has been notified. The study results will be presented at both national and international conferences and will also be published in a peer-reviewed journal.

NCT06265558.

To compare elective surgeries rates and waiting times between Indigenous and non-Indigenous patients in Queensland.

Aggregated annual data analysis from July 2013 to December 2022 on elective surgeries and waiting times.

Public hospitals across Queensland.

All patients who had elective surgery in Queensland public hospitals between 2013 and 2022.

Rates and clinically recommended timeframes for elective surgeries.

Between 2013 and 2022, the overall estimated average rate of elective surgeries for Indigenous patients was 286 per 100 000 population, compared with 221 per 100 000 for non-Indigenous patients. Indigenous patients had higher rates of most elective surgeries except plastic and urological surgeries, where non-Indigenous patients had higher rates. Across all urgency categories, the percentages of elective surgery performed within clinically recommended timeframes were similar between Indigenous and non-Indigenous patients.

Our findings may point to the efficacy of specific policy and service delivery innovations undertaken in Queensland. Due to the limitations of our aggregated data, this inference warrants careful interpretation. More studies with disaggregated data are needed.

Retroperitoneal sarcomas (RPS) are rare and often large malignancies that frequently require extensive surgery for complete tumour removal. Resections of the colorectum are part of the standard resection, this way contributing to complication rates, including anastomotic leakage or obstruction. Surgical strategies for stoma formation and colorectal reconstruction remain poorly defined. The Colorectal Resections and Postoperative Quality of Life in Retroperitoneal Sarcoma Patients Across German-Speaking Sarcoma Centres (COLOSARC-Q) study aims to explore surgical procedures and health-related quality of life (HRQoL) in patients undergoing colorectal procedures during RPS surgery.

COLOSARC-Q is a prospective, multicentre, non-interventional study and will recruit 120 patients with primary RPS who undergo colorectal resection as part of sarcoma surgery in a sarcoma referral centre in Germany or Switzerland. HRQoL is assessed using standardised questionnaires (EORTC QLQ-C30, QLQ-CR29) as well as semi-structured interviews by psycho-oncology services and patient advocates. Data will be collected via an electronic Case Report Form, encompassing demographic, clinical, surgical and outcome-related information. All data will be centrally analysed. For the assessment of quality of life, a qualitative analysis with content and context analysis, as well as evaluation of the questionnaires according to a standardised scoring system, is planned. The primary aim is to evaluate surgical techniques for bowel resection and reconstruction and their influence on the further course of disease. Secondary endpoints assess postoperative complications as well as tumour-, patient- and treatment-related factors.

Ethical approval was granted by the Ethics Committee II of the University of Heidelberg (approval number 2024-562; 13 June 2024). The data protection review was approved by the data protection officer of the University of Heidelberg. Participation of other centres in the study requires local ethical approval. All patients will be required to sign an informed consent form. Results of primary and secondary endpoints will be published.

NCT06943612; German Clinical Trials Registry (DRKS00034135).

Crohn’s disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract distinguished by progressive bowel damage with a risk of structuring and penetrating complications. It is characterised by focal or segmental transmural inflammation that disrupts intestinal mucosal integrity and favours the development of abscesses and fistulas. Perianal fistula develops in 13%–39% of patients with CD. Their care is difficult but improves with medical and surgical treatment to preserve anal continence and avoid a maximum proctectomy. Combined treatment with seton placement and concomitant anti-TNF (infliximab, adalimumab) allows wound healing in 40%–70% of cases. The currently available treatments are not curative and fail to provide a long-term resolution. The injection of adipose stromal cells is currently being evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischaemia, osteoarthritis, systemic sclerosis, etc). Immunoregulatory and anti-inflammatory properties of AdMSC (adipose-derived stroma/stem cells) are responsible for accelerating healing and represent an innovative approach for treating perianal fistulas associated with CD.

This phase I/IIa study is designed to assess the treatment of complex perianal fistulas linked with CD after failure of conventional treatment by injection of AdMSC (CellReady) into the fistula. Two doses of associated AdMSC will be tested for a dose escalation (5x10⁷ and 10x10⁷ cells) and injected into the wall of the fistula. Those eligible for inclusion include patients with controlled luminal CD characterised by a Harvey-Bradshaw score below or equal to eight and diagnosed on clinical, endoscopic, histological and/or radiological criteria, a colonoscopy dating back less than 1 year without ulcer in the rectum and presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports. All patients must have social security insurance or equivalent social protection. The aim of this study is to determine the optimal dose corresponding to maximum efficacy 6 months after injection of cells with a treatment-related adverse event rate of 20%.

The EU CT number 2024-511821-75-00 was approved by the following Ethics Committee: CPP (committee for the protection of persons in French: comité de protection des personnes) Ouest 1 – Tours #2024UEMED-18 and ANSM (French Agency for the Safety of Health and Medicinal Products in French : Agence nationale de sécurité du médicament et des produits de santé) #2024-511821-75-00 (Sponsor number RC31/13/7030, protocol V2.1). The results will be disseminated through conventional scientific channels.

NCT06636032.

The results will be disseminated through conventional scientific channels.

Both varicose veins (VV) and iliac vein compression syndrome (IVCS) can cause skin damage and functional impairment in the lower extremities, and these issues often coexist. However, the question of whether IVCS exacerbates VV progression and leads to differences in the surgical outcomes of therapy for VV remains unanswered. Therefore, no high-level evidence-based medical data is available to support the concomitant use of iliac vein stenting in patients with VV and severe IVCS, and treatment protocols vary significantly among different centres. This study will investigate the effects of concomitant iliac vein stenting on post-procedure varices recurrence and quality of life (QoL) on the basis of a prospective, multicentre, randomised controlled trial with the goal of providing a foundation for the standardised treatment of patients with VV and IVCS.

This prospective, multicentre, randomised controlled trial will enrol 160 patients with VV and severe IVCS. All patients will be randomly divided into either the VV endovenous thermal ablation (ETA) alone group or the VV ETA combined with iliac vein stenting (ETAS) group. Baseline data will be collected and follow-up will be conducted at 1, 6, 12 and 36 months after the procedure. The primary outcome is post-procedure VV recurrence (as assessed by clinical and ultrasound examination). Secondary outcomes include QoL scores (according to the Aberdeen Varicose Vein Questionnaire, the Chronic Lower Limb Venous Insufficiency Questionnaire, the European Quality of Life Five-Dimensions, and the Venous Clinical Severity Score) and the incidence of post-procedure complications. Bleeding complications resulting from anticoagulation therapy and stent-related complications (such as restenosis and deep vein thrombosis) will also be recorded for patients in the ETAS group.

This study has been approved by the Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (approval number: XJTU1AF2024LSYY-075). Written informed consent has been obtained from all participants. The final results of this study will be published in a peer-reviewed journal and presented at national or international conferences.

This protocol was registered on chictr.org.cn prior to enrolment, which began on 19 June 2024 (Registration ID: ChiCTR2400085815).

Severe pectus excavatum (PE) may impair cardiopulmonary and physical function. The effectiveness of surgical treatment to correct PE and restore physical function is widely debated due to a lack of high-quality comparative evidence. The RESTORE trial aims to determine the clinical and cost-effectiveness of corrective surgery for severe PE compared with conservative management for the first time in a randomised controlled trial (RCT).

RESTORE is a pragmatic, multicentre, RCT with an embedded observational cohort. 200 participants aged ≥12 years with severe PE will be recruited at around 12 National Health Service cardiothoracic surgical centres in England. Participants will be randomised 1:1 to receive either surgery within 3 months of randomisation (intervention arm) or no surgery until after the primary outcome measurement at 1 year (comparator arm). The primary outcome is change in physical functioning from baseline to 1 year as measured by the Short Form Health Survey (SF-36v2) physical function score. The primary economic outcome is cost-effectiveness. The key secondary outcome is change in % predicted VO_2peak at 1 year measured by cardiopulmonary exercise test (CPET). Outcomes will be assessed at 1 year post-randomisation in the comparator arm and 1 year post-surgery in the intervention arm. The primary analyses will be undertaken on an intention-to-treat population using a linear mixed-effects model, adjusted for stratification variables via a binary covariate. Other secondary outcomes will include change from baseline of cardiopulmonary function (CPET and spirometry), health-related quality of life using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) and SF-36v2 questionnaires, Hospital Anxiety and Depression Scale and disease specific symptoms (Phoenix Comprehensive Assessment for Pectus Excavatum Symptoms and Pectus Excavatum Evaluation Questionnaire). Adverse events, complications from surgery and operative technical success (Haller and Compression Indices from preoperative and postoperative CT scans) will also be assessed. Health economic analysis will estimate the incremental cost per quality adjusted life year at 1 year.

The trial was approved by East of Scotland Research and Ethics Service (24/ES/0034). Participants who are ≥16 years of age will be required to provide written informed consent. For participants

ISRCTN11359779.

Nasogastric tubes (NGTs) are standard practice in the management of adhesive small bowel obstruction (ASBO). Their insertion can be associated with significant patient discomfort and complications. Current research suggests that patients with ASBO managed with NGTs may experience poorer outcomes and higher rates of operative intervention compared with those managed without. However, to date, there are no prospective clinical trials evaluating this.

This study will be designed as a single centre, prospective, non-inferiority randomised controlled trial to determine if the avoidance of an NGT is non-inferior to its use in ASBO. Patients meeting inclusion criteria will be randomised to either receive an NGT or no NGT for ASBO management. The primary outcome will be the rate of operative intervention as determined by review of medical records at day 30 post discharge. Secondary outcomes will include rate of bowel resection or bowel ischaemia, length of hospital and intensive care unit (ICU) stay, time to operative intervention, rate of ICU admission, incidence of postoperative complications (Clavien-Dindo classification), quality of life scores (European Quality of Life 5 Dimension 5 Level: EQ-5D-5L) at admission, day 30 and day 90, 90-day mortality, incidence of pulmonary complications (Melbourne Group Scale), rate of NGT specific complications and rate of Gastrografin use. The study will be powered at 80% to detect a clinically relevant difference of 10% between groups receiving an NGT compared with no NGT, requiring a total of 490 study participants. Statistical analysis will follow intention to treat principles. Differences between treatment arms will be summarised using mean differences, 95% CIs and p values.

This study has been approved by the Hunter New England Human Research Ethics Committee (2023/ETH00296). Results will be disseminated through peer-reviewed publication and conference presentations.

This study has been registered prospectively in the Australia and New Zealand Clinical Trials Registry (ACTRN12623000341628).

To explore whether large language models (LLMs), Generative Pre-trained Transformer (GPT)-3, GPT-3.5 and GPT-4 can autonomously manage a virtual fracture clinic (VFC) as a marker of their efficacy in an emergency department and with simple orthopaedic trauma.

Simulated UK VFC workflow.

11 clinical scenarios were generated, and GPT-4, GPT-3.5 and GPT-3 were prompted to write clinic letters and management plans.

The Readable Tool was used to assess the clarity of letters. Six independent orthopaedic surgeons then evaluated the accuracy of letters and management plans.

Readability was compared using the Flesch-Kincaid grade level: GPT-4: 9.11 (SD 0.98); GPT-3.5: 8.77; GPT-3: 8.47, and the Flesch readability ease: GPT-4: 56.3; GPT-3.5: 58.2; GPT-3: 59.3. Surgeon-rated accuracy comparisons indicated that GPT-4 exhibited the highest accuracy for management plans (9.08/10 (95% CI 8.25 to 9.9)). This represents a statistically significant progression in the capacity of a LLM to provide accurate management plans compared with GPT-3 at 6.84 (95% CI 5.41 to 8.27) and GPT-3.5 at 7.63 (95% CI 7.23 to 8.13) (p

LLMs can produce high-quality, readable clinical letters for common VFC presentations, and GPT-4 can generate management plans to aid clinicians in their administration. With clinician oversight, appropriately trained LLMs could meaningfully reduce routine administrative work. However, while the results of this study are promising, further evaluation of LLMs is required before they can be deemed safe for managing simple orthopaedic scenarios.

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

jRCTs031240007.

Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

ISRCTN12216466.

Complete mesocolic excision (CME) with central vascular ligation (CVL) has been proposed as an oncologically superior surgical technique for right-sided colon cancer, mirroring the impact of total mesorectal excision (TME) in rectal cancer. While promising results have been reported, evidence from routine clinical practice, particularly within Swiss healthcare settings, remains limited. This study aims to evaluate the surgical and oncological outcomes of CME compared with standard right hemicolectomy (non-CME) over a 10-year period.

This is a retrospective cohort study of adult patients who underwent right hemicolectomy, either CME or non-CME, for histologically confirmed adenocarcinoma of the right colon or right third of the transverse colon at a tertiary centre, between 2010 and 2020. Patients with concomitant malignancies or distant metastases will be excluded. The primary outcome is 3-year and 5-year disease-free survival. Secondary outcomes include number of harvested lymph nodes, 3-year and 5-year overall survival, and 30-day morbidity.

This study was approved by the relevant Ethics Committee (CER-VD 2025-00503). All patients provided general consent for secondary use of anonymised data. Results will be submitted to a peer-reviewed journal and presented at national and international conferences.

Proximal humeral fractures are increasingly common, particularly among older people, whereas the prognosis of surgical treatments for these fractures remains substantially uncertain. In China, where the ageing population is rapidly growing, high-quality prospective data on surgical outcomes, complications and cost-effectiveness are lacking. To address this gap, we propose to initiate a prospective, multicentre cohort study on surgical treatment for proximal humeral fractures in China—Cohort of Acute Shoulder Trauma (CAST) study.

The CAST is a multicentre, prospective cohort study enrolling patients with acute proximal humeral fractures undergoing surgical treatments at eight hospitals in China between May 2024 and December 2029. Patients can receive any of the surgical treatment methods which include percutaneous Kirschner wire fixation, external fixation, open reduction and internal fixation using locking plates or intramedullary nails, suture anchors and shoulder arthroplasty. We will collect patient-reported outcome measures (Quick Disabilities of the Arm, Shoulder and Hand), Constant-Murley, American Shoulder and Elbow Surgeons, EuroQol 5-Dimension and Visual Analogue Scale), physical examination results, imaging assessments (based on X-rays, ultrasound, CT and MRI scans), laboratory tests (including inflammatory cytokines) and data on medical costs. We will follow patients at 1 day, and at 1 month, 3 months, 6 months, 12 months and 24 months postoperatively. The planned sample size is 1500 patients.

The study protocol has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University (Approval No. 2024-ky-104(K)). Written informed consent will be obtained from all participants. Findings from the CAST study will be disseminated through peer-reviewed journals and academic conferences.

ChiCTR2500109651.

Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.

A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.

The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.

ClinicalTrials.gov PRS (ID NCT06451432).

Colorectal cancer (CRC) incidence is increasing, and treating low rectal cancer poses challenges in balancing oncological control with functional preservation. While preoperative chemoradiotherapy (CRT) improves sphincter preservation, anastomotic leakage (AL) remains a major complication. This trial aims to compare the efficacy of modified pull-through procedure versus coloanal anastomosis (CAA) with temporary stoma in low rectal cancer patients following preoperative CRT.

This is a multicentre, assessor-blinded, randomised controlled trial. A total of 216 patients with low rectal cancer (≤7 cm from the anal verge) after preoperative CRT will be enrolled and randomly assigned (1:1) to undergo either the modified pull-through procedure or CAA with temporary stoma. The primary outcome is the incidence of AL within 1 month. Secondary outcomes include complications (Clavien-Dindo classification), length of hospital stay, anorectal function (LARS score (Low Anterior Resection Syndrome Score)), and quality of life (EQ-5D questionnaire (EuroQol five dimensions questionnaire)). Patients will be followed for 36 months.

The study has obtained ethics approval from the Biomedical Ethics Committee of West China Hospital, Sichuan University (ethics approval ID: 2025-Review-(144)). All centres have obtained local institutional review board approval. Results will be disseminated via academic conferences and peer-reviewed journals to optimise clinical practice for low rectal cancer surgery.

ChiCTR2500100246.