In children, open inguinal hernia repair has been the gold standard for treatment, but with recent technical advancements in laparoscopy, laparoscopic hernia repair is gaining popularity. Despite available results from comparative studies, there is still no consensus regarding the superiority of open versus laparoscopic treatment strategy. An important reason for lack of consensus is the large heterogeneity in the trials’ reported outcomes and outcome definitions, which limits comparisons between studies and precludes conclusions regarding the superiority of treatment strategies. The development and implementation of a core outcome set (COS) is a solution for this heterogeneity in the selection, measurement and reporting of trial outcome measures across studies. Currently, there is no COS for the treatment of paediatric inguinal hernia.

The aim of this project is to reach international consensus on a minimal set of outcomes that should be measured and reported in all future clinical trials investigating inguinal hernia repair in children. The development process comprises three phases. First, we identify outcome domains associated with paediatric inguinal hernia repair from a patient perspective and through a systematic review of the literature using EMBASE, MEDLINE and the Cochrane Library databases. Second, we conduct a three-step Delphi study to identify and prioritise ‘core’ outcomes for the eventual minimal set. In the third phase, an expert meeting is held to establish the final COS and develop implementation strategies with participants from all stakeholder groups: healthcare professionals, parents and patients’ representatives. The final COS will be reported in accordance with the COS-Standards for Reporting statement.

The medical research ethics committee of the Amsterdam UMC confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that full approval by the committee is not required. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at relevant conferences.

CRD42021281422.

To summarise evidence on the effectiveness of Platelet-Rich Plasma (PRP) gel and Leucocyte and Platelet Rich Fibrin (L-PRF) gel as agents promoting ulcer healing compared with the standard wound dressing techniques alone.

Systematic review.

Individual patient randomised controlled trials on skin ulcers of all types excluding traumatic lesions.

Intervention group: treatment with topical application of L-PRF gel or PRP gel to the wound surface.

Control group: treatment with standard skin ulcer care using normal saline, normgel or hydrogel dressings.

Medline (Ovid), Excerpta Medica Database (EMBASE), Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science and manual search of studies from previous systematic reviews and meta-analyses. The papers published from 1946 to 2022 with no restriction on geography and language were included. The last date of the search was performed on 29 August 2022.

Independent reviewers identified eligible studies, extracted data, assessed risk of bias using V.2 of the Cochrane risk-of-bias tool for randomised trials tool and assessed certainty of evidence by using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

Time to complete healing, proportion healed at a given time and rate of healing.

Seven studies met the inclusion criteria, five using PRP gel and two using L-PRF gel. One study showed a better proportion of complete healing, three reported reduced meantime to complete healing and five showed improved rate of healing per unit of time in the intervention group. The risk of bias was high across all studies with one exception and the GRADE showed very low certainty of evidence.

The findings show potential for better outcomes in the intervention; however, the evidence remains inconclusive highlighting a large research gap in ulcer treatment and warrant better-designed clinical trials.

CRD42022352418.

Frailty has consistently demonstrated associations with poorer healthcare outcomes. Vascular guidelines have recognised the importance of frailty assessment. However, an abundance of frailty tools and a lack of prospective studies confirming suitability of routine frailty assessment in clinical practice has delayed the uptake of these guidelines. The Frailty Assessment in Vascular OUtpatients Review study speaks to this evidence gap. The primary aim is to assess feasibility of implementing routine frailty assessment in a reproducible outpatient setting. Secondary objectives include comparing prognostic values and interuser agreement across five frailty assessment tools.

This single-centre prospective cohort study of feasibility is conducted in a rapid-referral vascular surgery clinic, serving a population of 2 million. Adults with capacity (>18 years), attending a clinic for any reason, are eligible for inclusion. Five assessments are completed by patient (Rockwood Clinical Frailty Scale (CFS) and Frail NonDisabled Questionnaire), clinician (CFS, Healthcare Improvement Scotland FRAIL tool and ‘Initial Clinical Evaluation’) and researcher (11-item modified Frailty Index). Consistent with feasibility objectives, outcome measures include recruitment rates, frailty assessment completion rates, time-to-complete assessments and interuser variability. Electronic follow-up at 30 days and 1 year will assess home-time and mortality as prognostic indicators. Patients treated surgically/endovascularly will undergo additional 30-day and 1-year postoperative follow-up, outcome measures include: surgical procedure, mortality, complications (according to Clavien-Dindo Classification), length of stay, readmission rates, non-home discharge, home-time, higher social care requirements on discharge and amputation-free survival. Prognostic value will be compared by area under receiver operating characteristic curves. Continuous outcome variables will be analysed using Spearman’s rank correlation coefficient. Interuser agreement will be compared by percentage agreement in Cohen’s kappa coefficient.

The study is sponsored by National Health Service Greater Glasgow and Clyde (R&IUGN23CE014). London-Riverside REC (23/PR/0062) granted ethical approval. Results will be disseminated through publication in peer-reviewed vascular surgery and geriatric medicine themed journals and presentation at similar scientific conferences.

NCT06040658. Stage of study: pre-results.

Despite early mobilisation as a key component of enhanced recovery after surgery pathways for pancreatic surgery, the implementation of early mobilisation remains unsatisfactory. What factors influence the implementation of early mobilisation from the lens of all stakeholders is unclear. The aim of this study was to identify the influencing factors of early mobilisation in pancreatic surgery from the perspective of patients, family members and health professionals.

A qualitative descriptive design using individual interviews and focus groups.

Twenty-two patients undergoing pancreatic surgery, 10 family members and 10 healthcare professionals from a large university teaching hospital in China.

We collected data on participants’ views on factors influencing early mobilisation after pancreatic surgery. Two researchers independently reviewed the transcripts and emergent coding. The data were analysed using qualitative content analysis.

Three main categories that influenced the implementation of early mobilisation in pancreatic surgery were identified: (1) attitude towards early postoperative mobilisation (eg, perceived advantages or disadvantages of early mobilisation), (2) subjective norm (eg, impact from health professionals, family members and fellow patients) and (3) perceived behavioural control (eg, knowledge, abilities, resources and environment).

Factors influencing early mobilisation are diverse and multidimensional. The successful implementation of early mobilisation requires the dedication of both patients and healthcare professionals.

Stroke remains the second leading cause of death worldwide, a common cause of which is intracranial atherosclerotic stenosis (ICAS). Medical treatment is recommended as first-line therapy for treating ICAS, but the recurrence rate remains high. Drug-coated balloon (DCB) angioplasty has been designed to lower the risk of recurrent stenosis, holding therapeutic promise in the treatment of ICAS. However, the benefits of DCB require further evaluation.

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols was followed to develop this protocol. We will systematically search online databases including Cochrane Central Register of Controlled Trials, PubMed, Web of Science, EMBASE, China Biological Medicine Database, ClinicalTrials.gov and WHO ICTRP from 1 January 2011 to the date of search. This will be supplemented by a manual search of unpublished and ongoing trials to manually select articles for inclusion. Inclusion criteria are randomised or quasi-randomised clinical trials and observational studies that investigated DCB or medical treatment for patients with a symptomatic ICAS of 50%–99%. The primary outcome is short-term composite safety including death of any cause, or non-fatal stroke. Secondary outcomes include long-term death or stroke, restenosis, neurological rehabilitation, quality of life and other complications. The available data will be analysed using meta-analysis, if appropriate. The evaluation of heterogeneity and biases will be guided by the Cochrane Handbook for Systematic Reviews of Interventions.

This systematic review does not require ethical approval as all available data from eligible studies will be anonymous with no concerns regarding privacy. Our findings will be disseminated through international conferences and peer-reviewed publications. Additional data from the study are available on request to corresponding authors via email.

CRD42022341607.

Intraperitoneal dexamethasone has been reported to be effective to reduce the incidence of postoperative nausea and vomiting (PONV). Therefore, this meta-analysis will analyse the efficacy and safety of intraperitoneal dexamethasone on PONV following laparoscopy.

Electronic databases (eg, Cochrane Library, PubMed, Excerpta Medica Database, Web of Science, National Institute of Informatics, Oriental Medicine Advanced Searching Integrated System and China National Knowledge Infrastructure) and clinical trial registries will be systematically searched from their inception to 1 October 2022. After the study and data collection processes, we will identify randomised controlled trials that reported details of intraperitoneal dexamethasone on PONV following laparoscopy to conduct a meta-analysis. We will perform the study process and data collection separately. The collected data will be statistically analysed using Review Manager 5.4 software. The risk of bias will be assessed using the Cochrane risk-of-bias tool 2. The Grading of Recommendations Assessment, Development and Evaluation certainty assessment, and a trial sequential analysis will be conducted to ensure the accuracy of this meta-analysis.

Ethical approval and patient consent are not required since this study is a systematic review and meta-analysis. The findings of this meta-analysis will be submitted to a peer-reviewed journal for publication.

CRD42022362924.

Osteoarthritis (OA) is one of the main causes of mobility impairment in the elderly worldwide. Therefore, total knee arthroplasty (TKA) is often performed and is one of the most successful surgery and has resulted in substantial quality-of-life gains for people with end-stage arthritis. There is still room for improvement in the standard treatment process in the preoperative, intraoperative and postoperative period of TKA. Telerehabilitation has the potential to become a positive alternative to face-to-face rehabilitation nowadays. But it remains unclear how well telemedicine interventions cover the entire surgical pathway (preoperation, intraoperation, postoperation). This study aims to explore the effectiveness of Joint Cloud (JC, an online management platform) compared with existing standard process in regulating functional recovery, pain management, muscle strength changes and other health-related outcomes in patients undergoing total knee arthroplasty preoperation, intraoperation and postoperation.

A randomised controlled trial was designed to compare the online management platform (JC) with standard process (SP) in patients undergoing TKA. A total of 186 TKA patients will be randomly assigned to the intervention (n=93) or control (n=93) group. Patients in the intervention group will receive access to the ‘JC’ mini-program. This mini-program provides popular science information (eg, information about OA and TKA), functional exercise information and communication channels. Patients evaluate their condition and functional level through standardised digital questionnaires. The control group of patients will not accept any functions of this mini-program. The primary outcome is knee functional recovery, and the secondary outcomes are pain management, isometric knee extensor muscle strength, patient satisfaction and cost-benefit analysis. Assessments will be performed 1 month and 3 days before surgery (T0) and 1 month and 3 months after surgery. Data analysis will be performed according to the intent-to-treat (ITT) principle. Repeated measures of linear mixed models and parametric and non-parametric testing will be used for statistical analysis.

The study was reviewed and approved by the Tianjin Hospital Medical Ethics Review Committee on 10 February 2023 (2022YLS155). Test data are considered highly sensitive but are available upon request. The findings will be disseminated in peer-reviewed publications.

ChiCTR2300068486.

Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined ‘C-arm rotational view (CARV)’ in order to reduce the risk of rotational malalignment during intramedullary nailing of tibial shaft fractures. The CARV includes predefined fluoroscopy landmark views of the uninjured side to obtain correct alignment of the injured side with use of the rotation of the C-arm.

This randomised controlled trial will be conducted in a level 1 trauma centre. Adult patients with an open or closed tibial fracture, eligible for intramedullary nailing, will be enrolled in the study. The interventional group will undergo intramedullary nailing guided by the CARV protocol to obtain accurate alignment. The control group is treated according to current clinical practice, in which alignment control of the tibia is based on clinical estimation of the treating surgeon. The primary endpoint is defined as the degree of rotation measured on low-dose postoperative CT scans.

The study protocol will be performed in line with local ethical guidelines and the Declaration of Helsinki. The results of this trial will be disseminated in a peer-reviewed manuscript. Future patients are likely to benefit from this trial as it aims to provide a clinically feasible and easy-to-use standardised fluoroscopy protocol to reduce the risk for rotational malalignment during intramedullary nailing of tibial shaft fractures.

NCT05459038.

Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.

A systematic review identified randomised placebo-controlled surgical trials. Articles published from database inception to 31 December 2020 were retrieved from Ovid-MEDLINE, Ovid-EMBASE and CENTRAL electronic databases, hand-searching and expert knowledge. Pilot/feasibility work conducted prior to the RCTs was then identified from examining citations and reference lists. Where studies explicitly stated their intent to inform the design and/or conduct of the future main placebo-controlled surgical trial, they were included. Publication type, clinical area, treatment intervention, number of centres, sample size, comparators, aims and text about the invasive placebo intervention were extracted.

From 131 placebo surgical RCTs included in the systematic review, 47 potentially eligible pilot/feasibility studies were identified. Of these, four were included as true pilot/feasibility work. Three were original articles, one a conference abstract; three were conducted in orthopaedic surgery and one in oral and maxillofacial surgery. All four included pilot RCTs, with an invasive surgical placebo intervention, randomising 9–49 participants in 1 or 2 centres. They explored the acceptability of recruitment and the invasive placebo intervention to patients and trial personnel, and whether blinding was possible. One study examined the characteristics of the proposed invasive placebo intervention using in-depth interviews.

Published studies reporting feasibility/pilot work undertaken to inform main placebo surgical trials are scarce. In view of the difficulties of undertaking placebo surgical trials, it is recommended that pilot/feasibility studies are conducted, and more are reported to share key findings and optimise the design of main RCTs.

CRD42021287371.

This study aims to illuminate the perspectives of informal caregivers who support people following hip fracture surgery.

A qualitative study embedded within a now completed multicentre, feasibility randomised controlled trial (HIP HELPER).

Five English National Health Service hospitals.

We interviewed 20 participants (10 informal caregivers and 10 people with hip fracture), following hip fracture surgery. This included one male and nine females who experienced a hip fracture; and seven male and three female informal caregivers. The median age was 72.5 years (range: 65–96 years), 71.0 years (range: 43–81 years) for people with hip fracture and informal caregivers, respectively.

Semistructured, virtual interviews were undertaken between November 2021 and March 2022, with caregiver dyads (person with hip fracture and their informal caregiver). Data were analysed thematically.

We identified two main themes: expectations of the informal caregiver role and reality of being an informal caregiver; and subthemes: expectations of care and services; responsibility and advocacy; profile of people with hip fracture; decision to be a caregiver; transition from hospital to home.

Findings suggest informal caregivers do not feel empowered to advocate for a person’s recovery or navigate the care system, leading to increased and unnecessary stress, anxiety and frustration when supporting the person with hip fracture. We suggest that a tailored information giving on the recovery pathway, which is responsive to the caregiving population (ie, considering the needs of male, younger and more active informal caregivers and people with hip fracture) would smooth the transition from hospital to home.

ISRCTN13270387.Cite Now

This study aims to determine hospital variation and intensive care unit characteristics associated with failure to rescue after abdominal surgery in Norway.

A nationwide retrospective observational study.

All 52 hospitals in Norway performing elective and acute abdominal surgery.

All 598 736 patients undergoing emergency and elective abdominal surgery from 2011 to 2021.

Primary outcome was failure to rescue within 30 days (FTR30), defined as in-hospital or out-of-hospital death within 30 days of a surgical patient who developed at least one complication within 30 days of the surgery (FTR30). Other outcome variables were surgical complications and hospital FTR30 variation. Statistical analysis was conducted separately for general surgery and abdominal surgery.

The 30-day postoperative complication rate was 30.7 (183 560 of 598 736 surgeries). Of general surgical complications (n=25 775), circulatory collapse (n=6127, 23%), cardiac arrhythmia (n=5646, 21%) and surgical infections (n=4334, 16 %) were most common and 1507 (5.8 %) patients were reoperated within 30 days. One thousand seven hundred and forty patients had FTR30 (6.7 %). The severity of complications was strongly associated with FTR30. In multivariate analysis of general surgery, adjusted for patient characteristics, only the year of surgery was associated with FTR30, with an estimated linear trend of –0.31 percentage units per year (95% CI (–0.48 to –0.15)). The driving distance from local hospitals to the nearest referral intensive care unit was not associated with FTR30. Over the last decade, FTR30 rates have varied significantly among similar hospitals.

Hospital factors cannot explain Norwegian hospitals’ significant FTR variance when adjusting for patient characteristics. The national FTR30 measure has dropped around 30% without a corresponding fall in surgical complications. No association was seen between rural hospital location and FTR30. Policy-makers must address microsystem issues causing high FTR30 in hospitals.

To develop a consensus on evidence-based principles and recommendations for perioperative hypothermia prevention in the Australian context.

This study was informed by CAN-IMPLEMENT using the ADAPTE process: (1) formation of a multidisciplinary development team; (2) systematic search process identifying existing guidance for perioperative hypothermia prevention; (3) appraisal using the AGREE II Rigor of Development domain; (4) extraction of recommendations from guidelines meeting a quality threshold using the AGREE-REX tool; (5) review of draft principles and recommendations by multidisciplinary clinicians nationally and (6) subsequent round of discussion, drafting, reflection and revision by the original panel member team.

Australian perioperative departments.

Registered nurses, anaesthetists, surgeons and anaesthetic allied health practitioners.

A total of 23 papers (12 guidelines, 6 evidence summaries, 3 standards, 1 best practice sheet and 1 evidence-based bundle) formed the evidence base. After evidence synthesis and development of draft recommendations, 219 perioperative clinicians provided feedback. Following refinement, three simple principles for perioperative hypothermia prevention were developed with supporting practice recommendations: (1) actively monitor core temperature for all patients at all times; (2) warm actively to keep body temperature above 36°C and patients comfortable and (3) minimise exposure to cold at all stages of perioperative care.

This consensus process has generated principles and practice recommendations for hypothermia prevention that are ready for implementation with local adaptation. Further evaluation will be undertaken in a large-scale implementation trial across Australian hospitals.

Management of an endoscopically resected malignant colorectal polyps can be challenging due to the risk of residual tumour and lymphatic spread. International studies have shown, that of those choosing surgical management instead of surveillance strategy, there are between 54% and 82% of bowel resections without evidence of residual tumour or lymphatic spread. As surgical management entails risks of complications and surveillance strategy entails risks of residual tumour or recurrence, a clinical dilemma arises when choosing a management strategy. Shared decision-making is a concept that can be used in preference-sensitive decision-making to facilitate patient involvement and empowerment to facilitate active patient participation in the decision-making process.

This study protocol describes our clinical multi-institutional, non-randomised, interventional phase II study at Danish surgical departments planned to commence in the second quarter of 2024. The aim of this study is to examine whether shared decision-making and using a patient decision aid in consultations affect patients’ choice of management, comparing with retrospective data. The secondary aim is to investigate patients’ experiences, perceived involvement, satisfaction, decision conflict and other outcomes using questionnaire feedback directly from the patients.

There are no conflicts of interest for principal or local investigators in any of the study sites. All results will be published at Danish and international meetings, and in English language scientific peer-reviewed journals. Our study underwent evaluation by the Regional Committees on Health Research Ethics for Southern Denmark (file number 20232000-47), concluding that formal approval was not required for this kind of research.

NCT05776381.

Electrocautery is used widely in surgical procedures, but making skin incision has routinely been performed with scalpel rather than electrocautery, for fear that electrocautery may cause poor incision healing, excessive scarring and increased wound complication rates. More and more studies on general surgery support the use of electrocautery for skin incision, but research comparing the two modalities for scalp incision in neurosurgery remains inadequate. This trial aims to evaluate the safety and efficacy of needle-tip monopolar for scalp incision in supratentorial neurosurgery compared with steel scalpel.

In this prospective, randomised, double-blind trial, 120 eligible patients who are planned to undergo supratentorial neurosurgery will be enrolled. Patients will be randomly assigned to two groups. In controlled group scalp incision will be made with a scalpel from the epidermis to the galea aponeurotica, while in intervention group scalp will be first incised with a steel scalpel from the epidermis to the dermis, and then the subcutaneous tissue and galea aponeurotica will be incised with needle-tip monopolar on cutting mode. The primary outcomes are scar score (at 90 days). The secondary outcomes include incision pain (at 1 day, on discharge, at 90 days) and alopecia around the incision (at 90 days), incision blood loss and incision-related operation time (during operation), incision infection and incision healing (on discharge, at 2 weeks, 90 days).

This trial will be performed according to the principles of Declaration of Helsinki and good clinical practice guidelines. This study has been validated by the ethics committee of West China Hospital. Informed consent will be obtained from each included patient and/or their designated representative. Final results from this trial will be promulgated through publications.

ChiCTR2200063243.

Training programmes for obstetrics and gynaecology (O&G) and general surgery (GS) vary significantly, but both require proficiency in laparoscopic skills. We sought to determine performance in each specialty.

Prospective, observational study.

Health Education England North-West, UK.

47 surgical trainees (24 O&G and 23 GS) were subdivided into four groups: 11 junior O&G, 13 senior O&G, 11 junior GS and 12 senior GS trainees.

Trainees were tested on four simulated laparoscopic tasks: laparoscopic camera navigation (LCN), hand–eye coordination (HEC), bimanual coordination (BMC) and suturing with intracorporeal knot tying (suturing).

O&G trainees completed LCN (p

GS trainees performed better than O&G trainees in core laparoscopic skills, and the structure of O&G training may require modification.

ClinicalTrials.gov Registry (NCT05116332).