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.

Randomised controlled trials (RCTs) are central to generating high-quality evidence in the surgical field but face unique methodological and practical challenges, including recruitment, follow-up, blinding and ensuring patient-centred outcomes. Patient and public involvement (PPI) has emerged as a promising strategy to enhance the relevance, quality and impact of surgical research by actively involving patients throughout the whole research process. Despite growing recognition of its value, the integration and reporting of PPI in surgical RCTs remain inconsistent, and no systematic evaluation has yet addressed its application within general and abdominal surgery.

RCTs in general and abdominal surgery published since 2014 will be identified through systematic searches of the databases MEDLINE, Web of Science and CENTRAL. This systematic review and primary (meta-epidemiological) statistical analysis will assess the reporting prevalence, implementation extent and quality of PPI over time. The Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2)-SF checklist and Cochrane Risk of Bias V.2.0 tool will be used to evaluate PPI reporting and study quality. To enable a comparison between studies reporting PPI and those that do not, propensity score matching will be performed to identify non-PPI studies with similar population and design characteristics. Subsequently, regression analyses will be employed to investigate potential associations between PPI reporting and various trial characteristics, including patient recruitment and retention, outcome selection and methodological quality. The Patient Advisory Board of the Study Centre of the German Society of Surgery is actively engaged in all phases of the systematic review.

This systematic review does not require ethical approval. Results will be published in an international peer-reviewed scientific journal, as well as distributed in a lay format to the patient community and to the broader public.

CRD42024524426.

Low anterior resection syndrome (LARS) is a common functional complication after sphincter-preserving surgery for rectal cancer that significantly impairs the quality of life. Current postoperative management strategies are suboptimal, and effective preventive approaches are lacking. This study aims to evaluate the impact of a mobile-based, knowledge-enhanced digital intervention for reducing the incidence of major LARS.

This is a multicentre, open-label, parallel-group, randomised controlled trial to be conducted across three academic medical centres in Korea.

A total of 300 adult patients who underwent low anterior resection or stoma reversal after rectal cancer surgery will be randomly assigned in a 1:1 ratio to the intervention group (mobile digital programme) or the control group (standard educational materials). The digital programme includes daily symptom monitoring, exercise suggestions, dietary recommendations and structured feedback from healthcare providers during clinical visits based on outcomes. The primary outcome is the incidence of major LARS (score ≥30) at 12 months postoperatively. Secondary outcomes include longitudinal changes in LARS score, quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), EORTC QLQ-Colorectal Cancer 29 (CR29)), European Quality of Life 5 Dimensions Level Version (EQ-5D-5L), patient satisfaction and programme adherence. Statistical analyses will include stratified chi-squared tests and mixed-effects models based on the intention-to-treat principle.

The trial received ethical approval from the Institutional Review Board of the National Cancer Centre, Korea. Written informed consent will be obtained from all participants. The findings will be disseminated through peer-reviewed publications and conference presentations.

NCT07041515.

This scoping review will evaluate and synthesise what is known about the impact of structural and social determinants of health on neurodegeneration among adults of African American or Black (AAB) racial identity with a history of traumatic brain injury (TBI). The primary objective is to examine how structural factors, such as healthcare access, influence disparities in neurodegeneration following TBI. Given higher rates of TBI and worse outcomes among Black individuals compared with White individuals, this review seeks to fill the gap in research concerning underrepresentation of AAB populations.

Guided by the Joanna Briggs Institute Evidence framework, this review will systematically search PubMed (MEDLINE), Embase and Cochrane CENTRAL Library (Wiley) for relevant studies. Eligible studies will involve adult human participants diagnosed with neurodegenerative conditions, including dementia and cognitive impairment, and with a history of TBI. Studies must include participants of AAB and non-Hispanic White (NHW) racial identity to facilitate comparisons. The review will focus on identifying potential factors contributing to disparities in neurodegeneration. Data synthesis will include narrative summaries, comparative tables and visualisations to highlight racial disparities in neurodegeneration risk and AAB representation in TBI research. This approach is its structured framework will evaluate the depth of racial inclusion across studies, allowing for a more nuanced understanding of how structural and social determinants shape outcomes.

As this review involves only previously published literature, institutional review board approval will not be required. The findings will be disseminated through peer-reviewed publications, conference presentations and lay summaries.

Peripheral arterial disease (PAD) commonly coexists with chronic kidney disease (CKD). Patients with symptomatic PAD often require endovascular revascularisation to relieve pain or salvage limbs. However, the iodinated intra-arterial contrast routinely used in these procedures is nephrotoxic, placing patients with CKD at increased risk of acute kidney injury (AKI) and long-term renal decline. Carbon dioxide (CO₂) delivered via automated injection is a potential alternative imaging contrast medium. This trial will evaluate whether using CO₂ instead of iodinated contrast reduces the risk of AKI and short-term renal function decline in this high-risk group.

This is a multicentre, open-label, prospective randomised controlled trial across six secondary-care National Health Service (NHS) vascular surgery centres. A total of 174 patients with PAD and CKD undergoing endovascular intervention will be randomised 1:1 to receive iodinated contrast (standard of care) or CO₂ via automated injector (Angiodroid). All perioperative care will follow local NHS protocols.

The primary outcome is log serum creatinine at 2, 30 and 90 days postprocedure. Key secondary outcomes include: incidence and severity of AKI within 48 hours postprocedure, major adverse kidney events (death, dialysis or >25% estimated glomerular filtration rate decline) by 90 days, inpatient length of stay, procedural pain, quality of life, procedural success, reinterventions, acceptability and feasibility (patient/practitioner questionnaires) of using CO₂, and cost-effectiveness (healthcare resource use analysis). A mixed-methods process evaluation will be undertaken with patients and clinicians.

The trial has been approved by an NHS ethical review committee (24/WA/0332) and patients have been involved in trial design. Findings will be disseminated to participants, clinicians and the wider public through patient groups, lay summaries, social media, conferences, peer-reviewed journals and NHS policy channels.

ISRCTN23564393.

Endometriosis affects 5–10% of women during reproductive years, with a 20–30% incidence among those with infertility. Deep infiltrating endometriosis (DIE) affects 10–15% of women of childbearing age and 50% of infertile women. When hormonal therapy and conservative surgery prove ineffective, total hysterectomy with or without bilateral salpingo-oophorectomy may be the ultimate therapeutic option. Laparoscopic surgery is the gold standard for treating endometriosis, offering effective disease eradication, safety, reduced pain, shorter hospital stay and faster recovery compared with laparotomy. However, patients undergoing total laparoscopic hysterectomy with DIE have higher risks of complications and organ damage, particularly urinary tract damage. Robot-assisted laparoscopic hysterectomy has emerged as a promising alternative, with a significantly lower conversion rate than total laparoscopic hysterectomy in patients with endometriosis. This study evaluates the safety and efficacy of robot-assisted total laparoscopic hysterectomy (RATLH) versus total laparoscopic hysterectomy (TLH) in the management of DIE. We hypothesise that robot-assisted laparoscopic hysterectomy will result in fewer complications and better outcomes compared with total laparoscopic hysterectomy in DIE patients.

The ENDORAS trial is a prospective, multicentre, open-label, randomised controlled trial conducted in French reference hospitals specialising in endometriosis surgery. A total of 224 adult women patients will be enrolled in this study if they have DIE with adenomyosis, and without digestive tract involvement as confirmed by MRI. Participants will be randomised to undergo either RATLH or TLH. The primary outcome will be the intraoperative and postoperative complication rates, classified according to the Clavien-Dindo classification (grade 2 or above) at the 3-month postoperative follow-up. Among the secondary outcomes, we will evaluate the quality of life using various questionnaires, including the Endometriosis Health Profile-30, the Short Form-306 and the Female Sexual Function Index.

The ENDORAS trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practice guidelines. All trial documents and procedures have been reviewed and approved by the Ethics Committee Ile de France II (approval ID number: 24.01408.000300). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media and the internet.

NCT06445179. Registered on 14 November 2024.

Corticosteroid injections are widely used as first-line treatment for trigger finger, but their comparative efficacy against other non-surgical and surgical interventions remains unclear. While previous meta-analyses have explored this topic, many were limited by a narrow scope or methodological constraints. This systematic review and meta-analysis aims to comprehensively evaluate the effectiveness and safety of corticosteroid injections in adult trigger finger management compared with alternative treatment modalities, using robust methodology and updated evidence to guide clinical decision-making.

A systematic search will be conducted to identify the articles published on PubMed, Embase, Scopus and the Cochrane Library. All randomised controlled trials that compared (1) corticosteroid injection with alternative non-surgical modalities and (2) corticosteroid injection with surgical intervention in adults diagnosed with trigger finger will be included for the review. Two reviewers will independently perform the processes of study inclusion, data extraction and quality assessment. The primary outcome will be assessed by improvement in triggering and pain symptoms. Secondary outcomes will be assessed through safety assessment. The risk of bias and meta-analysis will be conducted using by RevMan V.5.4.

Ethical approval is not required for this study as it is a review based on published studies. The results will be disseminated through peer-reviewed publications and conference presentations. The findings of this systematic review and meta-analysis results are expected to provide valuable information for clinicians to choose an optimal strategy for the management of trigger finger.

CRD42024547312.

Phasix mesh is a fully resorbable synthetic mesh for use in clean and contaminated ventral incisional hernia repairs. Long-term absorbable Phasix mesh appears to be a safe and promising device in incisional hernia repair, with low recurrence rates; however, data on long-term complications after surgery, particularly after the resorption period of the mesh, are scarce.

This protocol describes a study of several European registries on the use of a Phasix mesh in incisional hernia repair. The primary endpoint of the study is long-term complications at 2–5 year follow-up after mesh implantation, with secondary endpoints including hernia recurrence and complications during short-term follow-up.

Ethical approval was not required for this protocol as the study is based on anonymised registry data collected with prior patient consent in each registry. Each participating registry has its own ethical approval process, and this study will adhere to those regulations. The results will be disseminated through peer-reviewed publications and conference presentations.

Surgical margins are crucial in determining postoperative local recurrence (LR) in patients with colorectal liver metastasis (CRLM) and hepatocellular carcinoma (HCC). Achieving a margin greater than 1 cm can be challenging due to constraints related to remnant liver reserve, proximity to major vascular structures and tumour depth. We previously published findings from a retrospective study suggesting that additional margin coagulation (AMC) using radiofrequency may reduce LR, and this multicentre randomised clinical trial aims to further assess this hypothesis.

The LIVERATION trial is an international, multicentre, single-blind, randomised, parallel-group, controlled clinical trial involving 698 patients undergoing liver resection for CRLM or HCC. Participants will be randomly assigned in a 1:1 ratio to either AMC (study group) or conventional liver resection (control group) to assess oncological outcomes for both CRLM and HCC. The primary outcome is the incidence of LR. Secondary endpoints include overall survival, disease-free survival, cancer-specific survival, surgical complications and quality of life. Follow-ups occur at 30 days, 90 days, and 1, 2 and 3 years postoperatively.

The LIVERATION trial has been approved by the Ethics Committee at the sponsor site Hospital del Mar de Barcelona, CEIM-PSMAR (Comité de Ética de la Investigación con Medicamentos – Parc de Salut Mar), as well as by the Institutional Ethics Committees in all participating countries. The results of the main trial, along with each of the secondary endpoints, will be submitted for publication in a peer-reviewed journal. The study adheres to national and international guidelines, including the Declaration of Helsinki, and complies with regulations for studies involving biological samples under Law 14/2007 on Biomedical Research. A dissemination strategy has been developed to engage stakeholders and facilitate knowledge transfer to support the use of the findings of the study. LIVERATION is funded by the European Union under the Horizon Europe Framework Programme (Project Number: 101104360).

NCT05492136.

Cardiac surgical procedures are associated with a high incidence of postoperative infection, a risk attributed to their inherently invasive nature and extended duration. The goal of this study is to evaluate the efficacy of negative pressure wound therapy (NPWT) compared with standard dressings in preventing sternal scar dehiscence in patients undergoing cardiac surgery via complete vertical midline sternotomy, comparing a 3 day change system (NPWT 3/7 d) versus a 7 day wear system (NPWT 7d) versus standard dressings.

The PRISTER study is a prospective open-label multicentre, randomised, controlled, three-arm trial. Patients aged ≥18 years and meeting all the following inclusion criteria: patients undergoing scheduled or semiurgent cardiac surgery, with or without extracorporeal circulation, and patients managed by complete vertical median sternotomy will be recruited. Total sample size will consist of 660 patients. The primary outcome, surgical wound dehiscence after complete median sternotomy, expressed as occurrence or non-occurrence during the first 30 postoperative days, will be assessed by tablet calibrated photos analysed by an independent blinded staff. The secondary outcomes will be the number of dressing repairs between D7 (excluding initial protocol) and D90, length of initial hospital stay, occurrence of surgical site infection and its classification collected on day 90 (D90), use of an anti-infectious treatment and its duration, incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples, incidence of surgical revision for dehiscence of the surgical wound at D90 and collection of all operations involving surgical revision of the sternotomy wound, number of rehospitalisations (including hospital consultations) and their duration (evaluated at D90). Medicoeconomic assessment will be assessed by evaluation of hospital and extrahospital costs (number of days in hospital, consultations, rehospitalisations, imaging, biology and drugs), dressing costs and patient quality of life by EQ-5D-5L.

The study was approved by the French Agency for the Safety of Health Products (ANSM, Agence National de Sécurité du Médicament) as well as by the Ethics Committee (CPP Ile de France VIII) N°ID-RCB: 2023-A01782-43. Recruitment began in April 2024 and ended on 26 May 2025.

clinicaltrials.gov NCT06207630.

Total mesorectal excision has been adopted as standard procedure for resectable rectal cancer. However, there is no regulation in the current guidelines on the sequence of ligation of the inferior mesenteric artery and vein during rectal cancer surgery owing to a lack of sufficient evidence. Circulating tumour cells (CTCs) in peripheral blood can be used as potential indicators for predicting postoperative recurrence and prognosis in patients with colorectal cancer. The aim of the study is to investigate whether vascular ligation sequence affects the dissemination of CTCs into the bloodstream and survival during minimally invasive rectal cancer surgery.

This study is a prospective, multicentre, randomised controlled trial investigating the effect of ligation sequence (inferior mesenteric artery vs vein priority) on CTC levels and survival outcomes in minimally invasive rectal cancer surgery. 268 eligible patients with rectal cancer will be randomly assigned to the priority ligation of the inferior mesenteric vein group or priority ligation of the inferior mesenteric artery group during minimally invasive rectal cancer surgery. The primary endpoint of this study is the change of peripheral blood CTC levels before and after surgery, analysed using the Wilcoxon rank sum test. Secondary endpoints are 3-year disease-free survival, 3-year overall survival, 3-year recurrence pattern, intraoperative blood loss, operation duration, conversion rate, number of lymph nodes collected, intraoperative morbidity and mortality, postoperative morbidity and mortality and postoperative recovery course.

The study has been approved by the ethics committee of Sichuan Cancer Hospital (Approval number: SCCHEC-02-2024-102), all participants of the study will be well informed and written informed consent will be obtained from all participants. Findings from this trial will be published in peer-reviewed publications.

NCT05807646.

Pathology of the long head of the biceps tendon (LHBT) frequently accompanies rotator cuff tears, with tenotomy and tenodesis often being used to address this pathology. While meta-analyses report comparable functional outcomes between these techniques, tenotomy is linked to higher rates of Popeye deformity, whereas tenodesis is more technically demanding and might involve extra material. A novel self-locking tenodesis technique aims to reduce deformity risk while being a simpler alternative to the conventional tenodesis procedure; however, comparative evidence is currently limited.

This single-centre, patient-blinded randomised controlled trial will enrol 100 patients aged ≥40 years with reparable, non-traumatic, full-thickness supraspinatus and/or infraspinatus and/or subscapularis tendon tears undergoing arthroscopic repair from January 2025 until January 2027. Key exclusion criteria include massive or irreparable tears, advanced glenohumeral osteoarthritis and prior shoulder surgery. Participants will be randomised to either 360 double lasso loop tenodesis or self-locking tenodesis. The primary outcome is the Constant score at 1 year, with a predefined non-inferiority margin of 10 points. Secondary outcomes include American Shoulder and Elbow Surgeons score, simple shoulder value score, LHB score, cosmetic appearance, pain scores and radiographic tendon migration. Statistical non-inferiority will be assessed using a one-sided t-test.

The study protocol received approval from the National Ethical Review Board in France (CPP Sud-Est V) and was registered at ClinicalTrials.gov. The results will be disseminated through publication in a peer-reviewed journal.

NCT06774820.

Osteoarthritis (OA) commonly affects the ageing population, particularly the hip joint. Total hip arthroplasty (THA) is a frequent procedure that relieves pain and improves mobility, though some patients experience persistent postoperative pain. With rising numbers of THA, optimising perioperative care and pain management is crucial to address the growing clinical burden and improve patient outcomes. Positive treatment expectations have shown promise in enhancing outcomes, especially in pain management. This study implements two strategies to optimise the patient’s treatment expectations, comprising enhanced physician communication and digital social observational learning. We will examine their separate and combined effects on preoperative expectations, negative emotions, postoperative pain, inflammation and function during recovery up to 12 months postoperatively.

This randomised controlled trial (RCT) investigates the impact of augmented physician communication and observational learning on treatment expectations and recovery. Participants (n=200) will be randomised into four groups: treatment as usual (TAU), augmented doctor conversation (aDOC), observational learning video (Video) and a combination of both (aDOC+Video). The aDOC group receives empathic communication and targeted information to strengthen self-efficacy. The Video group watches a model patient demonstrating successful recovery. The combined group receives both interventions. Outcomes will be assessed at multiple time points (4 days preoperatively; 1 and 4 days, 4 weeks and 3, 6 and 12 months postoperatively), including subjective pain ratings, mobility and objective physical function. The primary analysis will compare changes in pain intensity across groups. Secondary outcomes will include functional status, self-efficacy, recovery and systemic inflammatory markers. Statistical analysis involves repeated measures ANOVA and post hoc tests for between-group and within-group comparisons.

German Clinical Trials Register: DRKS00033212.

Multimorbidity or the presence of two or more long-term conditions is now common in people undergoing surgery. However, current care pathways often miss these healthcare encounters to support long-term health promotion. Therefore, there is a need for practical, scalable approaches that can be integrated into routine surgical care, for which limited solutions exist at present. We have co-designed a structured preoperative checklist to help identify and manage long-term conditions in patients listed for elective surgery. This study aims to evaluate the feasibility and acceptability of this preoperative checklist in patients undergoing elective surgery.

This is a mixed-methods feasibility study in one National Health Service trust in the UK. We will recruit up to 50 adults scheduled for elective surgery and use the checklist during initial surgical clinic appointments. Quantitative data will include recruitment and retention rates, completion of the checklist and baseline clinical characteristics, analysed using descriptive statistics. Qualitative data will be collected through semistructured interviews with up to 16 patients and clinicians. These interviews will be analysed thematically, guided by the Consolidated Framework for Implementation Research. Triangulation of quantitative and qualitative data will allow us to explore fidelity, acceptability, barriers and facilitators to implementation and refine the intervention ahead of a future pilot cluster randomised trial.

This study has received approval from the Yorkshire & The Humber - Sheffield Research Ethics Committee (approval number: 25/YH/0045). All participants will give written informed consent. Results will be published in peer-reviewed journals and shared with participants, the public and policy stakeholders.