International Journal of Surgery Protocols最新文献

Background: Myofascial trigger points (MTrPs) precipitate the shoulder pain severity and disability in patients with shoulder adhesive capsulitis (SAC). This study aims to compare the effectiveness of intramuscular electrical stimulation (IMES) combined with therapeutic exercises versus dry needling (DN) combined with therapeutic exercises in improving the clinical outcomes in patients with SAC.

Methods and materials: In this randomized controlled trial, IMES (n = 45) and DN (43) groups had received respectively IMES, and DN twice weekly for three consecutive weeks. Both groups received therapeutic exercises 1520 minutes, five days in a week during the second and third week. Pain, disability, kinesiophobia, number of active and latent MTrPs, shoulder abduction and external rotation range of motion were assessed at baseline, week-1, week-2, week-3 and follow-up at 3 months. A repeated measures ANOVA performed to find out the significant differences in the clinical outcomes between the groups.

Results: The results of repeated measures of ANOVA shows that the post intervention timelines assessment scores of VAS, DASH, shoulder abduction and external rotation ROM, number of active and latent MTrPs and kinesiophobia were significantly (p. < 0.05) improved in both groups. However, IMES group had achieved a greater improvement over DN group (p. < 0.05) on the shoulder pain severity and disability, shoulder range of motion, number of active and latent MTrPs and kinesiophobia. Despite the significant statistical differences between the groups, IMES group did not achieve the minimal clinically important differences of 1.5cm and 11-points respectively for the VAS and DASH scores. No serious adverse effects occurred during the three weeks of treatment.

Conclusion: IMES combined with therapeutic exercises is an effective treatment to reduce the shoulder pain severity and upper limb disability by deactivating the active and latent MTrPs and improving the shoulder abduction and external rotation range of motion in patients with SAC.

Introduction: This two-phase study seeks to contribute to research in the field of rural cancer health; specifically, the aim is to gain insight into the experiences of seeking, accessing and using information and health services throughout the cancer journey (diagnosis, treatment and follow-up care) for recently diagnosed (≤6 months) older patients (≥65 years) in rural areas.

Methods and analysis: Data will be collected through in-depth semi-structured interviews. In phase 1 (before 23^rd March 2020) interviews were conducted with healthcare professionals (HCP) to explore their experiences of delivering care to their elderly patients. In the second phase (starting January 2021) we will conduct interviews with cancer patients to understand the impact of COVID-19 and shielding on their experiences of being diagnosed, attending appointments and accessing and receiving support from community organisations and informal support from family and friends. Data gathered will be analysed using the Framework Method.

Ethics: The study has been approved by the Health Research Authority and the United Lincolnshire Hospitals NHS Trust. Initial favourable ethical opinion was granted on 1^st October 2019. Second favourable ethical opinion for amendments to reflect the impact of COVID-19 was received on 10^th August 2020. The study protocol has been registered on Research Registry.

Introduction: Gallstone disease is a disorder characterised by the formation of stones in the biliary tract. It is the most common biliary condition accounting for more than 98% of all gallbladder and biliary tract disorders. In Africa, previous studies have shown a relative rarity of this condition with a prevalence less than 5%; since it is between 2 and 5 times higher in other continents. A good knowledge of the profile of patient with gallstone disease in a surgical setting could allow to reduce gallstone disease complications and to tailor better the treatment. To our knowledge, there was no previous study about gallstone disease in this region even if there is a high prevalence of metabolic factors of gallstone disease.

Methods: This study objective is to describe the epidemiological, diagnostic and therapeutic profile of patients with gallstone disease at the Department of General Surgery of Saint-Louis Hospital (Senegal). It will be a single-centre retrospective cohort study in a period of 5 years (January 2015 - December 2020). The patients' record of the department of general surgery will be consulted and the patient contacted if there are missing data. Patients with gallstone disease diagnosed with imaging (ultrasonography and/or CT scan) regardless the presentation (asymptomatic, biliary colic, cholecystitis, common bile duct lithiasis, angio-cholitis, pancreatitis) will be included. Adults and paediatric patients will be enrolled. Patient records lacking sufficient data will be excluded. Studied parameters will be epidemiological, clinical, paraclinical and therapeutic aspects.

Ethics and dissemination: Anonymity and confidentiality of information collected in patients will be respected. This research protocol will be submitted to the Ethics Committee of our institution for approval. The knowledge of the profile of patients with gallstone disease in a surgical setting could allow to reduce gallstone disease complications and to tailor better the treatment. Finally, it will help to reduce the burden of gallstone disease.

Highlights: Gallstone disease is the most common biliary tract conditionTo our knowledge, there was no previous study about gallstone disease in this region even if there is a high prevalence of risk factors of gallstone disease (sickle cell disease, diabetes, obesity, hypercholesterolemia)Good knowledge of the profile of patients with gallstone disease in a surgical setting could allow to reduce gallstone disease complications and to tailor better the treatment.

Introduction: Although neoadjuvant treatment is recommended for patients with borderline resectable pancreatic cancer (BRPC), no standard neoadjuvant regimen has been established for BRPC with arterial involvement (BRPC-A), which is associated with a higher risk of margin-positive resection and poorer prognosis than BRPC with only venous involvement. Gemcitabine plus nab-paclitaxel (GnP) has been reported to significantly reduce tumor size in metastatic pancreatic cancer, and some retrospective studies suggested that neoadjuvant GnP for BRPC improved resectability and survival.

Methods and analysis: A prospective multicenter single-arm phase II study is conducted to evaluate the safety and efficacy of GnP as neoadjuvant chemotherapy for BRPC-A. The primary endpoint is the R0 resection rate. The secondary endpoints are the neoadjuvant chemotherapy response rate, resection rate, pathological response rate, incidence rate of adverse events, and quality of life.

Ethics and dissemination: This study protocol was approved by the institutional review board of Kyushu University (no. 181). The results will be published in a peer-reviewed journal and will be presented at medical meetings.

Highlights: Strategy for borderline resectable pancreatic cancer involving arteries (BRPC-A).There is no standard regimen for neoadjuvant chemotherapy for BRPC-A.Gemcitabine plus nab-paclitaxel (GnP) shows significant tumor shrinkage.Neoadjuvant GnP for BRPC-A increases resectability and margin-negative resection.

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: 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.