BACKGROUND: Surgical innovation often outpaces robust evaluation. This study used metabolic bariatric surgery (MBS), a field of high-intensity innovation, as a case study to evaluate reporting standards and ethical overs...BACKGROUND: Surgical innovation often outpaces robust evaluation. This study used metabolic bariatric surgery (MBS), a field of high-intensity innovation, as a case study to evaluate reporting standards and ethical oversight for experimental procedures within surgery. METHODS: A systematic review was conducted in accordance with PRISMA 2020 guidelines. PubMed/MEDLINE, the Web of Science, Scopus, the Cochrane Library, and Embase were searched from January 2000 to December 2024 using terms related to MBS, surgical innovation, and non-standard intestinal bypass procedures. Original studies reporting first-in-human or early clinical series of non-standard primary MBS involving significant intestinal modification were included and reviews, editorials, conference abstracts, revisional surgery, purely restrictive procedures, and device-based interventions were excluded. Two reviewers independently screened studies, extracted data on publication timing, patient numbers, follow-up, ethical approval, and trial registration, and assessed risk of bias using the Newcastle-Ottawa scale (NOS), the Joanna Briggs Institute critical appraisal checklist, and the ROBINS-I tool. RESULTS: From 57 included studies (10 754 patients), the median time from first human operation to publication was 5 (interquartile range 3-8) years. The median initial cohort size was 39 (range 1-1074) patients. Institutional Review Board or ethics committee approval was reported in 47 of 57 studies (82%), while prospective clinical trial registration was documented in only 6 of 57 studies (11%). Methodological quality was low (mean NOS score of 5.0 out of 9), with 56 of 57 studies judged at high risk of bias. Out of 57 studies, only 15 (26%) reported outcomes at ≥3 years and only 8 (14%) reported outcomes at ≥5 years. CONCLUSION: This MBS case study reveals delayed publication and a widespread lack of prospective trial registration, exposing over 10 000 patients to experimental procedures outside a transparent research framework. These findings highlight a systemic failure in surgical innovation governance and underscore an urgent need for a cultural shift towards mandatory, prospective oversight frameworks to ensure patient safety and credible evidence generation.
Wullaert L, van Leeuwen L, de Weerd V
… +9 more, Van M, Oomen-de Hoop E, Kraan J, Jansen MPHM, Martens JWM, Grünhagen DJ, Verheul HMW, Verhoef C, Wilting SM
BACKGROUND: Almost half of patients with colorectal liver metastases (CRLM) experience disease recurrence within one year after treatment with curative intent. To improve treatment, upfront identification of patients wit...BACKGROUND: Almost half of patients with colorectal liver metastases (CRLM) experience disease recurrence within one year after treatment with curative intent. To improve treatment, upfront identification of patients with CRLM at high risk of rapid disease recurrence is crucial. METHODS: In this retrospective cohort-study, pretreatment ctDNA levels were determined by the modified fast aneuploidy screening test-sequencing system (mFast-SeqS) in 182 patients with resectable CRLM who did not receive perioperative chemotherapy. Resulting aneuploidy scores were dichotomized using a predefined threshold and associated with clinical outcome. RESULTS: Of 182 analysed patients, 34 (19%) were classified as ctDNA high and 156 (81%) as ctDNA low. Recurrence-free (RFS) and overall survival (OS) were shorter in the ctDNA high versus low group, with 1-year RFS of 29% versus 52%, and 3-year OS of 48% versus 78% respectively (log-rank P = 0.029 and < 0.001 respectively). The cumulative incidence of multiorgan recurrence within the first year after local treatment was significantly higher in ctDNA-high patients (Gray's test P < 0.001). Multivariable Cox regression analysis revealed that the aneuploidy score is independently associated with RFS (HR = 1.94; 95% c.i. 1.19 to 3.18) and multiorgan RFS up to 1 year (HR = 2.56; 95% c.i. 1.41 to 4.65) and OS up to 3 years (HR = 3.28; 95% c.i. 1.79 to 6.01). CONCLUSIONS: This study shows that mFast-SeqS provides an affordable and minimally invasive test for the upfront recognition of patients with CRLM at increased risk of rapid (multiorgan) disease recurrence.
BACKGROUND: Large randomized studies show equivalent survival after breast-conserving surgery (BCS) + adjuvant radiotherapy (RT) and mastectomy. In contrast, more recent observational studies suggest BCS + RT to be super...BACKGROUND: Large randomized studies show equivalent survival after breast-conserving surgery (BCS) + adjuvant radiotherapy (RT) and mastectomy. In contrast, more recent observational studies suggest BCS + RT to be superior, but it is questionable whether patients in these treatment arms are comparable. Here, overall survival (OS) and breast cancer-specific survival (BCSS) after BCS + RT and mastectomy are compared within a randomized trial comparing intravenous and inhalation anaesthesia during breast cancer surgery. METHODS: The patient cohort was recruited from the randomized CAN-study. Patients with tumours >30 mm, patients with tumours <10 mm, and patients who underwent BCS without RT were excluded. OS and BCSS were estimated using multivariable Cox regression analyses and three different propensity score models. RESULTS: The final study cohort included 830 women, of whom 601 underwent BCS + RT (median age 64 years) and 229 underwent mastectomy (median age 68 years). Women who underwent mastectomy had more co-morbidities and more unfavourable tumour characteristics. Mastectomy was associated with significantly less favourable OS in unadjusted, adjusted, and two of the three propensity score analyses. BCSS was inferior in the mastectomy group in the unadjusted analysis, with an HR of 2.27 (95% c.i. 1.20 to 4.30). In the adjusted and three propensity score analyses, BCSS was equal in the treatment groups, with an adjusted HR of 1.02 (95% c.i. 0.43 to 2.42). CONCLUSION: In this study, which was designed to approximate a randomized trial as closely as possible, no significant difference in BCSS was observed between BCS + RT and mastectomy. Differences in OS likely reflect occult selection bias of patients with higher co-morbidity burden to mastectomy.
INTRODUCTION: Revascularization to prevent limb loss is not feasible or represents a very high risk in a significant proportion of patients with chronic limb-threatening ischaemia (CLTI). No standard definition currently...INTRODUCTION: Revascularization to prevent limb loss is not feasible or represents a very high risk in a significant proportion of patients with chronic limb-threatening ischaemia (CLTI). No standard definition currently exists to define this population of patients. The aim of this study was to develop a consensus-based, multidomain definition to improve clinical assessment and reporting of studies in people with 'no option' (NO) or 'poor option' (PO) CLTI. METHODS: A modified Delphi process was conducted with 164 specialists from 30 countries. Two iterative survey rounds were used to reach consensus, defined as ≥70% agreement with a score of ≥7 on a nine-point scale. RESULTS: Some 164 international vascular specialists participated in the study, averaging 19 years of experience. A multidomain framework including arterial disease anatomy, biology, risk, function, and context (ABRFC) achieved 83% consensus. A 'desert foot' was defined as the absence of distal arterial revascularization targets on advanced non-invasive imaging, invasive digital subtraction angiography, and at least one failed endovascular revascularization attempt (81.6% agreement). Inadequate autogenous bypass conduit was defined as the lack of usable autologous vein across all four limbs (85% agreement). Patients were classified as NO for revascularization if they present with 'desert foot', prohibitive medical risk, a non-functional limb, or in those patients who refused arterial revascularization. PO revascularization patients combined factors such as severe infection, lack of autologous vein, or treatment non-compliance (72.1% agreement). CONCLUSION: This consensus study established a structured, expert-validated definition of no option or poor option for revascularisation of patients with CLTI. The multidomain ABRFC framework provides a foundation for standardized clinical assessment, trial design, and future guideline development.
Squamous intraepithelial lesions are premalignant conditions for anal cancer, the incidence of which is slowly increasing worldwide. These premalignant lesions are commonly found in high-risk individuals such as those wh...Squamous intraepithelial lesions are premalignant conditions for anal cancer, the incidence of which is slowly increasing worldwide. These premalignant lesions are commonly found in high-risk individuals such as those who are immunosuppressed, and men who have sex with men. The development of squamous intraepithelial lesions is driven by chronic human papillomavirus infection that induces cellular proliferation and dysplastic modification in mucosal and cutaneous epithelia. Among a wide family of human papillomavirus strains, high-risk genotypes such as human papillomavirus 16 and 18 are responsible for most high-grade precancerous lesions and their subsequent progression to invasive cancer. Historically, premalignant lesions have been described by a variety of different classification systems that has changed as our understanding of their pathophysiology has evolved. Precancerous lesions are currently classified based on the degree of dysplasia in the anal epithelium. Anal intraepithelial neoplasia I or low-grade squamous intraepithelial neoplasia (LSIL) describes a low-grade dysplastic lesion capable of spontaneous regression, while anal intraepithelial neoplasia III or high-grade squamous intraepithelial neoplasia (HSIL) describes those lesions with capacity for infiltration and malignant change. The need for active screening in high-risk groups is now established, as proactive treatment of HSIL significantly reduces the development of anal cancer. High-resolution anoscopy is a diagnostic modality that allows for the identification and treatment of anal dysplasia, halting its progression to squamous cell carcinoma. Using vital dyes and dedicated instruments offering high magnification and resolution, it is possible to visualize and treat very small and/or flat premalignant lesions that would be invisible on standard diagnostic anoscopy. The evolution of artificial intelligence is set to further enhance its diagnostic ability, and shorten the learning curve for its implementation.
BACKGROUND: Fenestrated endovascular aneurysm repair (FEVAR) is increasingly used in patients who are not eligible for standard endovascular aneurysm repair (EVAR) devices due to anatomical constraints, principally of th...BACKGROUND: Fenestrated endovascular aneurysm repair (FEVAR) is increasingly used in patients who are not eligible for standard endovascular aneurysm repair (EVAR) devices due to anatomical constraints, principally of the proximal aortic neck. The long-term outcomes of FEVAR are not well described and therefore the aim of this study was to perform an analysis of a national registry in the UK. METHODS: The UK GLOBALSTAR registry (2003-2022) was analysed to report the long-term outcomes of FEVAR. Patients were included if they underwent FEVAR with custom-made devices for infradiaphragmatic aortic aneurysmal disease. Patients with extent I-III thoracoabdominal aneurysms or those who underwent other complex EVAR techniques were excluded. Time-to-event analyses were conducted for survival, aneurysm-related mortality, reintervention, endoleak, and target vessel patency. Subgroup analyses were conducted for octogenarians and patient sex. RESULTS: Some 1651 patients across 15 centres were included. The median age was 75 (interquartile range 69-79) years and 87.9% were male. Estimated survival at 3, 5, and 10 years was 79.5% (95% c.i. 77.6% to 81.5%), 64.1% (95% c.i. 61.7% to 66.6%), and 30.5% (95% c.i. 27.7% to 33.5%) respectively; median survival was 6.9 (95% c.i. 6.6 to 7.2) years. Aneurysm-related mortality was 6.4% (95% c.i. 5.1% to 7.7%) at 10 years. There were 36 secondary sac ruptures over follow-up. The cumulative incidence of reintervention at 3, 5, and 7 years was 21.5% (95% c.i. 19.5% to 23.6%), 25.6% (95% c.i. 23.4% to 27.8%), and 27.6% (95% c.i. 25.3% to 30.0%) respectively. Graft-related complications accounted for 74.5% of reinterventions. Women had significantly worse 2-year survival (81.1% (95% c.i. 75.8% to 86.8%)) than men (86.1% (95% c.i. 84.3% to 87.9%)) (P = 0.041), driven by increased perioperative mortality. Beyond 2 years, the differences in survival were not statistically significant. Octogenarians had equivalent survival (89.4% (95% c.i. 86.4% to 92.4%)) to non-octogenarians (92.1% (95% c.i. 90.7% to 93.6%)) up to 1 year (P = 0.074). Octogenarians' median survival was 5.4 (95% c.i. 5.0 to 6.1) years. CONCLUSIONS: Long-term outcomes of FEVAR appear acceptable, with low rates of secondary sac rupture. FEVAR is associated with a significant risk of reintervention, with graft-related complications being a key driver, suggesting effective planning and graft surveillance are key to long-term durability.
BACKGROUND: Inflammatory bowel disease (IBD) and colorectal cancer (CRC) share overlapping symptoms. Faecal immunochemical testing (FIT) is mandated in UK primary care to triage symptomatic patients suspected of having C...BACKGROUND: Inflammatory bowel disease (IBD) and colorectal cancer (CRC) share overlapping symptoms. Faecal immunochemical testing (FIT) is mandated in UK primary care to triage symptomatic patients suspected of having CRC, but the extent to which IBD is identified in these patients remains unclear. The aim of this study was to assess the 1-year IBD diagnosis rate in symptomatic patients after FIT for suspected CRC and how this varies with age, FIT level, and faecal calprotectin (FCP) result. METHODS: A population-based cohort study of symptomatic patients who underwent FIT in the UK Clinical Practice Research Datalink (CPRD) (January 2019-June 2023) with 1-year follow-up was conducted. Kaplan-Meier estimates were used to assess cumulative 1-year IBD risk, stratified by age, FIT level, and FCP result. RESULTS: Of 473 402 patients, 2762 patients (0.58%) were diagnosed with IBD within 1 year of FIT. Patients aged <50 years (110 501 patients) accounted for 53.6% of all IBD diagnoses (1481 patients), but only 6.9% of all CRC diagnoses (347 patients). Overall IBD risk was 2.3% with FIT ≥10 µg Hb/g compared with 0.1% with FIT <10 µg Hb/g. Among 63 469 patients with elevated FCP results and FIT levels, IBD risk in those aged <50 years was 21.0% with FIT ≥10 µg Hb/g and FCP >50 µg/g. The combined risk of CRC or IBD in those with FIT ≥10 µg Hb/g was 7.1%. This fell to 3.3% in the subset of patients who also had FCP ≤50 µg/g. CONCLUSION: IBD is more common than CRC in patients aged <50 years referred on symptomatic FIT pathways using FIT ≥10 µg Hb/g. In a selected cohort of dual-tested patients, FCP results provided additional risk stratification. Incorporating routine FCP testing into symptomatic FIT pathways may better target further investigations.
BACKGROUND: Complex endovascular repair has emerged as a minimally invasive alternative for thoracoabdominal aortic aneurysms (TAAAs). The aim of this study was to assess the short- and mid-term outcomes of endovascular...BACKGROUND: Complex endovascular repair has emerged as a minimally invasive alternative for thoracoabdominal aortic aneurysms (TAAAs). The aim of this study was to assess the short- and mid-term outcomes of endovascular TAAA repair in Sweden. METHODS: All endovascular TAAA repairs performed during 2018-2023 were identified in the Swedish Vascular (Swedvasc) Registry. Patient characteristics, operative details, and outcomes were analysed. The primary outcome was survival; secondary outcomes included complications and thoracoabdominal aortic life-altering events (TALEs). Predictors of mid-term outcomes were assessed in multivariable analysis. RESULTS: Some 339 patients were treated for TAAAs, which included 476 repairs (366 elective repairs and 110 emergency repairs) across 11 centres (94% concentrated in 5 centres). Elective patients (235 patients; mean diameter 64 mm) had 30-day, 90-day, and 1-year mortality of 2.6%, 3.5%, and 12.4% respectively. Major complications, vascular complications, and TALEs occurred in 16.2%, 9.8%, and 14% respectively. The use of prophylactic spinal drainage declined over time (from 68% to 14%) and the incidence of spinal cord ischaemia declined over time (from 20% to 2.3%). Mean(s.e.) 1-year and 4-year Kaplan-Meier survival estimates were 89.3%(2.1%) and 73.5%(3.7%) respectively. Emergency patients (104 patients; mean diameter 73 mm) had 30-day, 90-day, and 1-year mortality of 12.5%, 17.6%, and 26.9% respectively. Major complications, vascular complications, and TALEs occurred in 20.2%, 12.5%, and 24% respectively. Mean(s.e.) 1-year and 4-year Kaplan-Meier survival estimates were 75.2%(4.3%) and 56.5%(6.2%) respectively. Perioperative myocardial infarction was the strongest predictor of 1-year mortality after both elective and emergency repair. CONCLUSION: Endovascular TAAA repair in Sweden is associated with significant complication rates, but acceptable mid-term survival. Further research should focus on perioperative refinements, especially with regard to preserving organ function.
INTRODUCTION: In mature trauma systems, most trauma deaths occur soon after injury yet studies often only include patients who survive to hospital admission. These studies exclude pre-hospital deaths and introduce substa...INTRODUCTION: In mature trauma systems, most trauma deaths occur soon after injury yet studies often only include patients who survive to hospital admission. These studies exclude pre-hospital deaths and introduce substantial survival bias. Understanding trauma fatalities across all phases of care is essential to identify opportunities to further improve trauma outcomes. METHODS: This retrospective cohort study analysed adult trauma fatalities attended by London's Air Ambulance from 1 January 2019 to 31 December 2020. Deaths were classified as pre-hospital if traumatic cardiac arrest occurred before hospital arrival. Timing of death was recorded as minutes from injury to arrest for pre-hospital cases and days from admission to death for in-hospital cases. A multidisciplinary panel determined the likely cause of death using clinical, radiological, and post-mortem findings. RESULTS: Among 3,089 adult trauma patients attended, 497 (16.1%) died. Most deaths (77.1%) occurred pre-hospital, with a median time from injury to traumatic cardiac arrest of 12 minutes (IQR 6-24). Haemorrhage and traumatic brain injury accounted for 81.9% of deaths overall, but their distribution differed markedly by phase of care: 96.2% of haemorrhage deaths occurred pre-hospital, whereas 84.2% of in-hospital deaths were due to traumatic brain injury. In addition, deaths from all other potentially reversible causes, and 95.1% of penetrating trauma deaths, occurred pre-hospital. CONCLUSION: In mature trauma systems, most trauma deaths now occur before arrival in hospital, with many due to potentially reversible causes. The greatest opportunities to improve trauma outcomes now lie in the pre-hospital phase of care.
Hallet J, Falconi M, Buerba GA
… +39 more, Clarke C, Maxwell J, Soares H, Stättner S, Nieveen van Dijkum E, Acher AW, Andreasi V, Bartsch D, Bubis L, Cavallucci D, Chan D, Clemente U, Del Chiaro M, Daskalakis K, Dominguez-Rosado I, Dumitra T, Duncan K, Fermi F, Fusai GK, Hackert T, Howe JR, Huivaniuk I, Kaemmerer D, Landoni L, McNamara M, Niessen A, Pascher A, Perren A, Pommier R, Sachdeva S, Sadowski S, Sauvanet A, Singhi A, Sorbye H, Ward E, Wei A, Yen L, Soreide K, Partelli S
Boshier PR, Chia DKA, Thrumurthy SG
… +40 more, Teh JL, Wobith M, Bencivenga M, Filippini F, Dumitra TC, Burch M, Kim HI, Kobitzsch B, Kodach LL, Quik JSE, Long VD, de Neijs MJ, van der Sluis PC, Leon-Takahashi AM, Woo Y, Chevallay M, Framarini M, Morgagni P, Frejlich E, Grabsch HI, Markar SR, Marrelli D, Park DJ, Sundar R, Xu Z, Linn KK, Yang HK, Kitayama J, Zhu Z, Rha SY, Wijnhoven B, Yamashita H, Yong WP, de la Fouchardière C, Nilsson M, Ishigami H, Van Sandick JW, Lordick F, Badgwell BD, So JBY
BACKGROUND: Gastric cancer peritoneal metastasis (GCPM) is a common manifestation of advanced gastric cancer, associated with poor prognosis. METHODS: The International Gastric Cancer Association (IGCA) convened a multid...BACKGROUND: Gastric cancer peritoneal metastasis (GCPM) is a common manifestation of advanced gastric cancer, associated with poor prognosis. METHODS: The International Gastric Cancer Association (IGCA) convened a multidisciplinary working group of 42 global experts from 15 countries to develop a total of 13 consensus statements addressing diagnosis, treatment, and research priorities for GCPM. Using ACcurate COnsensus Reporting Document (ACCORD)-compliant methodology, the group conducted systematic literature searches and applied a structured Delphi process with anonymous Likert-scale voting and a ≥70% consensus threshold to generate and refine consensus statements. RESULTS: Consensus was achieved for all 13 statements among the working group during the first Delphi round, with 75-100% of respondents selecting either 'strongly agree' or 'agree'. Coefficient of variation values were ≤0.23. Polling of a broader group of experts (n = 66), which included members of the working group (n = 21), during a GCPM consensus session at the 16th International Gastric Cancer Congress (IGCC) in 2025 demonstrated agreement for 12 of the 13 statements. This broader group of experts, which had greater representation from medical oncologists, did not reach consensus (52% agreement) on best practice for systemic treatment of patients with GCPM, possibly due to the rapidly evolving developments in this field of metastatic gastric cancer. CONCLUSION: This consensus exercise provides a foundation for globally relevant GCPM management strategies and highlights critical research needed to address significant evidence gaps that will improve patient outcomes.
BACKGROUND: Prehabilitation, a process of building physiological reserve before surgery to improve postoperative outcomes, is a complex, multimodal intervention that requires rigorous evaluation in clinical trials. Incom...BACKGROUND: Prehabilitation, a process of building physiological reserve before surgery to improve postoperative outcomes, is a complex, multimodal intervention that requires rigorous evaluation in clinical trials. Incomplete reporting by such trials obscures essential intervention components and delivery contexts, hindering comparability and interpretability. This, in turn, limits clinical implementation and the replication or refinement of interventions by researchers. The aim of this study was to develop a reporting checklist for RCTs of prehabilitation. METHODS: A modified two-round Delphi process using the EQUATOR framework with 53 international experts across exercise, nutrition, psychological, and perioperative care disciplines was conducted. An initial checklist of candidate items was adapted from existing reporting standards, contextualized for prehabilitation, and iteratively refined through expert voting. Items rated eight to nine on a nine-point scale by ≥70% of participants in round two were classified as 'essential' and those rated seven were considered 'important'. RESULTS: The final checklist comprised 40 items. Sixteen items were classified as 'essential' and 24 items were classified as 'important' for guiding comprehensive reporting of prehabilitation interventions. These items span key domains including intervention components, delivery methods, adherence, participant characteristics, and outcome measures. High agreement among experts underscores the checklist's relevance and usability. CONCLUSION: Adoption of Standards for reporting research methods, interventions, and Outcomes in Surgical Prehabilitation studies (SOS-Prehab), alongside methodological and outcome-reporting items of CONSORT could improve transparency, completeness, and interpretability of prehabilitation trials. This could enable better reproducibility, robust evidence synthesis, and accelerate translation into clinical practice and policy.
Khanna R, Li Y, Cook M
… +13 more, Sawant P, Hounon R, Carroll D, Lowe L, Lindenroth L, Mahmoodi T, Raison N, Granados A, Ojha A, Bergeles C, Breda A, Ourselin S, Dasgupta P
As human spaceflight expands beyond low Earth orbit, the ability to deliver advanced surgical care in space becomes critical. Current medical provisions on board the International Space Station (ISS) are geared towards t...As human spaceflight expands beyond low Earth orbit, the ability to deliver advanced surgical care in space becomes critical. Current medical provisions on board the International Space Station (ISS) are geared towards treating low-risk conditions, with a 'stabilize-and-evacuate' principle for more complex cases-an approach that is not viable for extended missions to the Moon and Mars. This review summarizes research conducted around space surgery, with a particular focus on surgical robotics. Experiments in parabolic flight and analogue environments demonstrate that, provided the operator, patient, and instruments are restrained, surgical skill is largely unaffected by reduced gravity. Robotic surgery has primarily been explored in remote undersea habitats and in limited flight studies. There are several challenges to the implementation of surgical systems in space, including size, weight, and power constraints, communication latency, and crew training. Means of fluid and debris containment, provision of anaesthesia, and postoperative recovery in altered physiology must also be considered. The key features of an ideal space surgery robotic set-up are outlined. It should be compact, multifunctional, adaptable, reliable, and optimized in technical design and material composition for use in habitable volumes. Such systems should incorporate artificial intelligence (AI)-driven decision-making support, variable autonomy, and human-in-the-loop control. Crew members must be trained and supported to deliver and recover from surgical care in space. Cloud and edge computing will mitigate latency while expanding on-board data processing capabilities. Although not yet operationally mature, robotic surgery is a critical capability for future exploratory space missions, but requires continued multidisciplinary development.
BACKGROUND: The current evidence for preoperative low-energy diets (LEDs) for patients with a BMI >30 kg/m2 before non-bariatric surgery rests on studies with a high risk of bias. An RCT is warranted to bridge this knowl...BACKGROUND: The current evidence for preoperative low-energy diets (LEDs) for patients with a BMI >30 kg/m2 before non-bariatric surgery rests on studies with a high risk of bias. An RCT is warranted to bridge this knowledge gap. Before a larger RCT, a pilot feasibility RCT was conducted to address potential hurdles for the larger trial. METHODS: The pilot feasibility multicentre trial was conducted in Canada at four centres between 3 January 2024 and 23 October 2024. Patients were randomized (1 : 1 randomly permuted online blocked allocation) to receive a 3-week LED protocol or standard care. All patients aged >18 years with a BMI >30 kg/m2 undergoing elective non-bariatric intra-abdominal or orthopaedic surgery were evaluated for enrolment. Main exclusion criteria were LED contraindications and surgery scheduled without at least 3 weeks notice. The primary outcome was descriptive including the following feasibility outcomes: recruitment rate, randomization percentage, intervention adherence, and follow-up completion. Clinical outcomes included anthropometric data. The primary outcome analysis was descriptive. Additionally, a random-effects meta-analysis was performed using data from the present study and data from previously published RCTs to evaluate 30-day postoperative morbidity. The last follow-up date was 14 January 2025. RESULTS: Out of 373 patients approached, 288 were eligible. Of these, 175 consented to be randomized (60.8% (95% c.i. 54.9-66.4%)). Seventy four of these patients were still awaiting a surgical date when the trial closed, leaving 91 patients randomized (LED n = 45, control n = 46) in the present pilot trial. Out of these 91 randomized patients, 81 (89%, 95% c.i. 80.7-94.6%) had complete follow-up. LED adherence was 81.7% (95% c.i. 74.1-89.3%). Analysis of covariance suggested patients in the LED group lost more weight during the 3-week intervention period (MD 4.5kg, 95% c.i. -5.6 to -3.5). The pooled meta-analysis of 5 RCTs suggested a 19% relative risk reduction in postoperative morbidity favouring the intervention (RR 0.81, 95% c.i. 0.52-1.26, P = 0.351, I2 = 0%). CONCLUSION: The feasibility targets of this pilot RCT were not met for recruitment rate, randomization percentage, and complete follow-up. The pooled meta-analysis suggests that LEDs before non-bariatric surgery can effectively induce weight loss with reduced postoperative morbidity, which needs to be validated in a larger non-inferiority RCT with additional centres to meet the feasibility targets. REGISTRATION NUMBER: NCT03935451 (http://www.clinicaltrials.gov).
Toesca A, Magnoni F, Sangalli C
… +13 more, Maisonneuve P, Gottardi A, De Scalzi AM, Bottazzoli EI, Polizzi A, Peradze N, Presti D, Concardi A, Fusco N, De Lorenzi F, Corso G, Galimberti V, Veronesi P