International Journal of Surgery Protocols最新文献

Purpose: Post-operative urinary retention (POUR) is a well-recognised complication of inguinal hernia repair (IHR). The magnitude of the problem is unclear, and contradictory evidence surrounds postulated risk factors. POUR risks patient distress, catheter-complications and a financial and logistical burden to services. Separately, in the field of IHR, there has been a lack of research into patients' perceptions of surgical 'success'. Our aim is to perform a two-phase, multi-centre prospective study to:Assess the rate, risk factors and impact related to POUR post IH repair.Develop and validate a patient reported outcome measure (PROM) for inguinal hernia repair.

Methods: RETAINER I: We propose a 24-week prospective study with voluntary international participation in 4 week blocks. All patients undergoing elective IH repair (minimally-invasive/open) will be eligible. Standardised data collection will include patient and perioperative factors. Primary outcome will be development of POUR, defined as the need for insertion of a urinary catheter as determined by the treating clinician. Secondary outcomes will be identification of factors predisposing to POUR and the impact of POUR.RETAINER II: A patient reported outcome measure will be developed using representative patient focus groups for item generation, from which an initial questionnaire will be developed and piloted. Validity, reliability, sensitivity and reproducibility will be assessed using the QQ-10 and standard psychometric methodology.

Conclusions: Using an international multicentre collaborative approach will produce the necessary volume of patients, whilst capturing inter-centre variability, to accurately reflect POUR rates and allow analysis of risk factors. This patient pool will provide an excellent opportunity to develop a PROM using appropriate qualitative methodology.

Highlights retainer i & ii protocols: RETAINER (RETention of urine After INguinal hernia Elective Repair) I is a prospective, multicentre, international observational study.RETAINER I aims to explore the incidence of and risk factors for urinary retention following elective inguinal hernia repair.Urinary retention following inguinal hernia repair has a marked impact on patients and creates a significant financial and logistical burden for hospital services.RETAINER II is a prospective, qualitative study, recruiting patients to guide the creation of a patient-reported outcome measure (PROM) for elective inguinal hernia repair.

Background: Total Knee Arthroplasty (TKA) is an intervention that can significantly improve the quality of life of patients with advanced knee osteoarthritis. Early start of rehabilitation and its continuation at home once the patient is discharged are key factors for the success of the process.This study aims to assess the effectiveness of a home-based telerehabilitation solution (ReHub) on improving functional capacity and clinical outcomes for patients who underwent TKA.

Methods/design: The study is a randomized, open-label with blinded outcome assessor, parallel assignment clinical trial with a sample size of 52 patients that is conducted according to the SPIRIT recommendations. After the TKA intervention, the patients are randomly allocated to the control group or the experimental group with a 1:1 ratio. Both groups follow a Fast Track recovery protocol which includes discharge after 2-3 days from surgery, a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after surgery. The experimental group uses the sensor-based telerehabilitation system ReHub to perform the exercises. The primary outcome measure is the range of motion of the knee. Secondary outcomes include physical performance, quality of life, pain intensity, muscle strength, treatment adherence and satisfaction with the ReHub system. The outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).The study conforms to the guidelines of the Declaration of Helsinki and was approved by the hospital's ethics committee.

Discussion: The study will address an important gap in the evidence base by reporting the effectiveness of an affordable and low-cost home-based telerehabilitation solution in patients who underwent TKA.

Ethics and dissemination: The study was approved by the hospital's ethics committee ("Comité Ético de Investigación Clínica del HCB", reg. HCB/2019/0571). The trial was registred at ClinicalTrials.gov (NCT04155957). The results of this study will be published in peer-reviewed journals as well as national and international conferences.

Trial registration: NCT04155957 (ClinicalTrials.gov).

Highlights: Assessing a home-based telerehabilitation solution effectiveness in knee surgery.In situations such as the CoVid-19 pandemic, it is a resolutive intervention method.Telerehabilitation is an alternative to conventional face-to-face physical therapy.This system is far less demanding in terms of human resources.Range of motion assessment is the primary outcome measure.

Introduction: New medical devices must have adequate research, such that outcomes are known, enabling patients to be consented with knowledge of the safety and efficacy of the device to be implanted. Device trials are challenging due to the learning curve and iterative assessment of best practice. This study is designed to pilot a national collaborative approach to medical device introduction by breast surgeons in the UK, using breast localisation devices as an exemplar. The aim is to develop an effective and transferable surgical device platform protocol design, with embedded shared learning.

Methods and analysis: The iBRA-net localisation study is a UK based prospective, multi-centre platform study, comparing the safety and efficacy of novel localisation devices with wire-guided breast lesion localisation for wide local excision, using Magseed® as the pilot intervention group. Centres performing breast lesion localisation for wide local excision or excision biopsy will be eligible to participate if using one of the included devices. Further intervention arms will be added as new devices are CE marked. Outcomes will be collected via an online database. The primary outcome measure will be identification of the index lesion. Participating surgeons will be asked to record shared learning events via online questionnaires and focus group interviews to inform future study arms.

Ethics and dissemination: The study will aim to collect data on 950 procedures for each intervention (Magseed® and wire localisation) from UK breast centres over an 18-month period. Shared learning will be prospectively evaluated via thematic analysis to refine breast localisation technique and to promote early identification of potential pitfalls and problems. Results will be presented at national and international conferences and published in peer reviewed journals.

Registration: This is a UK national audit registered with Manchester University NHS Foundation Trust.

Highlights: This protocol outlines a novel methodology for a collaborative national platform study to collate safety and efficacy data on new medical devices. Improved registration and audit of new medical devices is a major theme of the Cumberlege report of the Independent Medicines and Medical Devices Safety Review.We outline a protocol for a UK based multi-centre prospective audit to investigate the safety and efficacy of new surgical devices for breast lesion localisation. The study will run as a platform study using wire localisation as a control group and Magseed® as the first intervention arm.The protocol is designed for additional bolt-on intervention arms for other localisation devices, such as Hologic Localizer™ and Savi Scout®, when they become available to the European market. This will enable comparison of these devices to datasets already collected on wire and Magseed® localisation.The stud

Introduction: The long head of biceps tendon is a common source of anterior shoulder pain and impaired function. Multiple surgical procedures are available as treatment options, but the optimal procedure is not known. The aim of this systematic review and meta-analysis is to review the literature to assess the clinical effectiveness of various surgical procedures to treat pain arising from the long head of biceps.

Methods: The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Electronic databases used for the literature search will include MEDLINE, EMBASE, PsycINFO, and The Cochrane Library. Randomised controlled trials (RCTs) evaluating surgical procedures on the long head of biceps will be included. Our primary outcome is any functional patient-reported outcome measure related to the shoulder. Secondary outcomes will include the rate of 'Popeye' deformity, the rate of biceps cramping pain, the rate of complications, objective measurements of strength testing such as dynamometer, and other patient-reported outcome measures not specific to the shoulder such as the Visual-Analog Scale (VAS) for pain. Methodological quality of included studies will be assessed using The Cochrane Risk of Bias Tool 2.0 and the Jadad score. Inconsistency and bias across included studies will be assessed statistically. Comparable outcome data will be pooled and analysed quantitatively or qualitatively as appropriate.

Ethics and dissemination: No ethical clearances required for this study. We plan to publish this systematic review and meta-analysis in a peer-reviewed journal. It will also be presented at various national and international conferences.

Highlights: Evaluating the clinical effectiveness of surgical procedures for long head of biceps pathology.Randomised controlled trials.Biceps tenodesis and biceps tenotomy.Systematic review compliant with the PRISMA guideline.

Introduction: Diabetes prevalence has increased over the past years. In Senegal, this prevalence is 4% in the general population. However, the region of Saint-Louis (in the north of the country) has the highest rate with 10.4%. The main prognosis problem is the occurrence foot lesions that can lead to lower-limbs amputation. Diabetic foot is a real public health issue, due to its economic burden and its serious repercussions on patients, leading to poor quality of life. The objective of this case-control study is to identify factors associated with foot lesions in diabetic patients.

Methods and analysis: It will be a case-control study from January to December 2021. The patients will be recruited from the departments of general surgery, internal medicine, and emergency. An univariate then multivariate analysis (logistic regression) will allow us to select the variables associated with foot lesions in our study population. The parameters included in the logistic regression will be those with a p < 0.20 in the univariate analysis. Finally, a binary logistic regression analysis (with the calculation of Odds Ratios (OR) with confidence intervals (CI)) according to the backward stepwise method will identify the factors independently associated to foot lesions in diabetic patients.

Ethics and dissemination: This research protocol will be submitted to the Ethics Committee of our institution for approval. The knowledge of factors causing diabetic foot will help to communicate with policymakers to raise the awareness in our community. Finally, it will help to prevent lower limb amputations.

Highlights: Diabetes is the leading cause of non-traumatic lower-limb amputation in the world.The region of Saint-Louis (Senegal) has the highest prevalence of diabetes.Controlling factors associated with foot lesions in diabetic patients can prevent from amputation.

Introduction: Anastomotic leakage (AL) accounts for a significant proportion of morbidity following oesophagectomy. Endoluminal negative pressure (ENP) therapy via a specifically designed polyurethane foam (EsoSponge^®, B.Braun Medical, Melsungen, Germany) has become the standard of care for AL in many specialized centres. The prophylactic (pENP) application of this technique aims to reduce postoperative morbidity and is a novel approach which has not yet been investigated in a prospective study. The aim of this study is therefore to assess the effect of pENP at the anastomotic site in high-risk patients undergoing minimally invasive transthoracic Ivor Lewis oesophagectomy.

Methods and analysis: The study design is a prospective, multi-centre, two-arm, parallel-group, randomised controlled trial and will be conducted in two phases. Phase one is a randomised feasibility and safety pilot trial involving 40 consecutive patients. After definitive sample size calculation, additional patients will be included accordingly during phase two. The primary outcome of the study will be the postoperative length of hospitalization until reaching previously defined "fit for discharge criteria". Secondary outcomes will include postoperative morbidity, mortality and postoperative AL-rates based on 90-day follow-up. A confirmatory analysis based on intention-to-treat will be performed.

Ethics and dissemination: The ethics committee of the University of Zurich approved this study (2019-00562), which has been registered with ClinicalTrials.gov on 14.11.2019 (NCT04162860) and the Swiss National Clinical Trials Portal (SNCTP000003524). The results of the study will be published and presented at appropriate conferences.

Introduction: Outcomes of hip arthroscopy for femoroacetabular impingement and concomitant moderate- to advanced hip osteoarthritis (Tönnis Grade II or greater) is still a matter of debate as findings in the literature are controversial. This study aims to investigate whether hip arthroscopy is effective in treating patients with femoroacetabular impingement and Tönnis hip osteoarthritis Grade II or greater.

Methods and analysis: The protocol follows the PRISMA-P guidelines. The systematic review is registered in the International Prospective Register for Systematic Reviews and Meta-analysis (PROSPERO) under the registration number: CRD42020210936. The search will include multiple databases: MEDLINE, EMBASE, Web of Science Core Collection and Cochrane library. The screening and selection process will be performed by two independent researchers based on predefined criteria. All studies published in English or German from inception to 1^st of December 2020 that investigated outcomes of hip arthroscopy in patients with Tönnis grade II or greater of hip osteoarthritis will be considered eligible. The risk of bias and quality of articles will be assessed using the MINORS tool. Methodological inconsistency and heterogeneity will be explored using the I² test. This assessment will be used to provide recommendations using the GRADE system.

Ethics and dissemination: Separate ethical approval is not required. This study will be a comprehensive and rigorous systematic review on all published articles reporting on outcomes of hip arthroscopy for femoroacetabular impingement and concomitant hip osteoarthritis Tönnis Grade II or greater. It will explore patient reported outcomes as well as radiological outcomes, complications, rates of revision surgery and rates of conversion to total hip replacement (THR). Results of the current review will be published in a peer-reviewed scientific journal and disseminated on research platforms according to copyright rules and rights.

Highlights: Hip arthroscopy is used to treat femoroacetabular impingement and is effective in patients that have concomitant hip osteoarthritis Tönnis Grade 0 or 1.Outcomes of hip arthroscopy in patients with femoroacetabular impingement and in moderate to advanced osteoarthritis - Tönnis Grade 2 or greater, is a matter of debate.The purpose of the current systematic review is to elucidate, stratify and critical appraise the current evidence on outcomes in this patient subpopulation.