International Journal of Surgery Protocols最新文献

{"title":"Antiemetic Prophylaxis Practice and its Associated Factors Among Health Professionals in Referral Hospitals of North West Ethiopia: Multicenter Cross-Sectional Study.","authors":"Yewlsew Fentie,&nbsp;Abraham Tarekegn,&nbsp;Moges Gelaw,&nbsp;Efrem Fenta","doi":"10.29337/ijsp.135","DOIUrl":"https://doi.org/10.29337/ijsp.135","url":null,"abstract":"<p><strong>Background: </strong>The practice of antiemetic prophylaxis within the prevention and management of postoperative nausea and vomiting is important for optimal care of surgical patients. The poor practice of antiemetic prophylaxis on postoperative nausea and vomiting prevention come up with complications, reduce patient satisfaction, and increase overall costs. This study aims to assess practice and associated factors of antiemetic prophylaxis among health professionals in referral hospitals of Northwest Ethiopia.</p><p><strong>Method and materials: </strong>Institutional based cross-sectional study was conducted on 407 health professionals from February 27 to March 30, 2019, in referral Hospitals of Northwest Ethiopia. A stratified random sampling technique was used to select the study participants. A structured questionnaire was used to collect data. Bivariable and multivariable logistic regression was used to identify factors associated with the antiemetic prophylaxis practice level of health professionals on postoperative nausea and vomiting prevention and management. The p-values of < 0.05 were considered statistically significant.</p><p><strong>Results: </strong>In this study 153 (37.6%) of health professionals were practicing antiemetic prophylaxis. The multivariable logistic regression analysis showed that anesthetists were (AOR: 8.11; 95% CI: 3.27, 20.08) and physicians (AOR: 4.78; 95% CI: 2.46, 9.30) were more likely to give anti-emetic prophylaxis as compared with midwives. Learning in academic classes (AOR: 3.83; 95% CI: 1.46, 10.09), took training (AOR: 6.97; 95% CI: 2.208, 22.021), professionals who said that there are enough anti-emetic drugs available (AOR: 3.10; 95% CI: 1.67, 5.77), professionals, who respond that patients can afford to buy antiemetic's (AOR: 3.56; 95% CI: 1.23, 10.32) were more likely to give anti-emetic prophylaxis as compared to their counterparts.</p><p><strong>Conclusions: </strong>Less than fifty percent (37.6%) of health Professionals practice antiemetic prophylaxis. Type of Profession, learning, training, availability, and cost of antiemetic drugs were factors significantly affecting the practice of antiemetic prophylaxis.</p><p><strong>Highlights: </strong>Less than fifty percent of health Professionals practice antiemetic prophylaxis.The availability, drugs affects the practice of antiemetic prophylaxis.The cost of anti-emetics affects the practice of antiemetic prophylaxis.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"98-107"},"PeriodicalIF":0.9,"publicationDate":"2021-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176933/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39235293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Designing a Clinical Trial Protocol about the Impact of Family-Based Multimedia Education Based on Telephone Tracking (Tele Nursing) to Improve the Quality of Life and Self-Efficacy in Patients with Myocardial Infarction.","authors":"Shirin Madadkar Dehkordi,&nbsp;Forogh Okhovat,&nbsp;Zohreh Karimiankakolaki","doi":"10.29337/ijsp.146","DOIUrl":"https://doi.org/10.29337/ijsp.146","url":null,"abstract":"<p><strong>Background: </strong>Provision of education to a person with myocardial infarction and an active family member, who takes care of the patient can prevent or delay the onset of the disease. Telephone tracking is a very useful and inexpensive way to assess the patients' needs and help them with their care problems. This clinical trial (interventional) protocol was conducted over the impact of family-based multimedia education based on the telephone tracking (tele-nursing) to improve the quality of life and self-efficacy in patients with myocardial infarction.</p><p><strong>Methods: </strong>Two phases are identified to design this study; the first phase includes designing a curriculum by investigating various studies and the panel of experts' opinions. This phase will be conducted in the form of multimedia training and telephone contact. Multimedia training (including audio, video, image, and animation) over the patients' lifestyle, nutrition, and care will be conducted through a one-day workshop in 2-3 hours for patients and one of their active family members. The active family member is defined as the primary caregiver, who spends more time with the patient. The educational course will be conducted at a coordinated date and time in the ward where the patients are hospitalized. The researcher will make telephone calls as the educational intervention and continue the follow-ups once a week for one month. The second phase of the intervention will contain a pre/post-test design along with application of Minnesota quality of life and Scherer general self-efficacy standard questionnaires in the intervention (with training) and control (without training) groups. The target participants will include all patients (and their active family members) admitted to CCUs of hospitals affiliated to Shahrekord University of Medical Sciences.</p><p><strong>Discussion: </strong>The present study provides useful data for designing a family-based multimedia educational intervention using the telephone-tracking method (tele-nursing) to improve the quality of life and self-efficacy in patients with myocardial infarction. It can also reduce their medical and treatment costs. The strategies of this program could be important and cost effective, and therefore we hope that the success of such a program is a step forward in improving cardiovascular patient's health status.</p><p><strong>Highlights: </strong>Family-based multimedia educational (tele-nursing) to improve the quality of life and self-efficacy in patients with myocardial infarction.Family-based multimedia educational (tele-nursing) can also reduce their medical and treatment costs.The program is a step forward in improving cardiovascular patient's health status.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"92-97"},"PeriodicalIF":0.9,"publicationDate":"2021-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162287/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39083099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying Patterns of Failure and Risk Factors for Recurrence in Patients of Paratesticular Sarcomas: Protocol of a Systematic Review and Meta-Analysis.","authors":"Anil Gupta,&nbsp;Rashi Kulshrestha,&nbsp;Kamal Kishore,&nbsp;Oliver Micke,&nbsp;Rishabh Kumar,&nbsp;Kanika Garg,&nbsp;Dayanand Sharma,&nbsp;Rambha Pandey","doi":"10.29337/ijsp.145","DOIUrl":"https://doi.org/10.29337/ijsp.145","url":null,"abstract":"<p><strong>Introduction: </strong>Para testicular sarcomas are rare mesenchymal tumors that affect patients of all ages. Unlike other sites of sarcoma, they tend to be of lower grade and have a higher propensity for lymphatic spread. Management is hampered by the small number of patients who differ in terms of tumor grade and histology. Current treatment approaches are based on case reports, small case series and literature reviews, resulting in a number of unresolved issues. The consensus on the type of surgery and adjuvant treatment is yet to be determined. The local relapse rates in the scrotum and groin after orchidectomy comes out to be 25%-37%, indicating the need for either aggressive surgery or adjuvant treatment. There is a paucity of data identifying the patterns of failure and risk factors for recurrence, which will help clinicians tailor appropriate treatment.</p><p><strong>Methods: </strong>We aim to perform a systematic review and meta-analysis of the available data in the last 50 years in a methodologically rigorous and transparent manner to identify patterns of failure and high-risk factors for recurrence. The protocol is prepared in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA-P) 2015 guidelines. The protocol is registered in the International Prospective Register of Systematic Reviews (CRD42021237134).</p><p><strong>Highlights: </strong>Para testicular sarcomas are rare mesenchymal tumors that affects patients of all ages. Current treatment approaches are based on case reports, small case series and literature reviews, resulting in a number of unresolved issues. A systemic review was performed in 2013 based on survival rates, prognostic factors, and relapse sites on paratesticular sarcomas. However, it lacks a comprehensive review that can guide radiation oncologists to select in which patient's postoperative radiotherapy is warranted and define the target volume based on histopathological type, stage, and grade of the tumor. After 2013, new case series with improved methodology and sample size are published, which adds new information to the literature. In one case series, 22 patients with spermatic cord sarcoma were discussed, while in another study, long-term outcome analysis of 51 patients was discussed, and another study discussed eight patients.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"84-91"},"PeriodicalIF":0.9,"publicationDate":"2021-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39083098","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intramuscular Electrical Stimulation Combined with Therapeutic Exercises in Patients with Shoulder Adhesive Capsulitis: A Randomised Controlled Trial.","authors":"Sukumar Shanmugam,&nbsp;Lawrence Mathias,&nbsp;Nagarajan Manickaraj,&nbsp;K U Dhanesh Kumar,&nbsp;Praveen Kumar Kandakurti,&nbsp;Sathees Kumar Dorairaj,&nbsp;Ramprasad Muthukrishnan","doi":"10.29337/ijsp.25","DOIUrl":"https://doi.org/10.29337/ijsp.25","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods and materials: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"71-83"},"PeriodicalIF":0.9,"publicationDate":"2021-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8139297/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38966372","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Study Protocol to Explore and Improve Access to Medical Services and Information for Recently Diagnosed Elderly Patients with Cancer in Rural Settings.","authors":"Gianina-Ioana Postavaru,&nbsp;Bethan Myers,&nbsp;Tanweer Ahmed,&nbsp;Douglas Lewins,&nbsp;Rosemary Brown,&nbsp;Helen Swaby","doi":"10.29337/ijsp.144","DOIUrl":"https://doi.org/10.29337/ijsp.144","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods and analysis: </strong>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.</p><p><strong>Ethics: </strong>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.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"66-70"},"PeriodicalIF":0.9,"publicationDate":"2021-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38930292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Profile of Patients with Gallstone Disease in a Sub-Saharan African General Surgery Department: A Retrospective Cohort Study Protocol.","authors":"A Ndong,&nbsp;N F Gaye,&nbsp;J N Tendeng,&nbsp;M L Diao,&nbsp;A C Diallo,&nbsp;F G Niang,&nbsp;S Diop,&nbsp;D A Dia,&nbsp;M Diedhiou,&nbsp;M Dieng,&nbsp;M L Fall,&nbsp;P M Ma Nyemb,&nbsp;I Konaté","doi":"10.29337/ijsp.143","DOIUrl":"https://doi.org/10.29337/ijsp.143","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Ethics and dissemination: </strong>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.</p><p><strong>Highlights: </strong>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.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"61-65"},"PeriodicalIF":0.9,"publicationDate":"2021-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38930291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel Regimen for Borderline Resectable Pancreatic Cancer with Arterial Involvement: A Prospective Multicenter Single-Arm Phase II Study Protocol.","authors":"Yoshihiro Miyasaka,&nbsp;Takao Ohtsuka,&nbsp;Susumu Eguchi,&nbsp;Masafumi Inomata,&nbsp;Kazuyoshi Nishihara,&nbsp;Hiroyuki Shinchi,&nbsp;Koji Okuda,&nbsp;Hideo Baba,&nbsp;Hiroaki Nagano,&nbsp;Toshiharu Ueki,&nbsp;Hirokazu Noshiro,&nbsp;Masafumi Nakamura","doi":"10.29337/ijsp.142","DOIUrl":"https://doi.org/10.29337/ijsp.142","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods and analysis: </strong>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.</p><p><strong>Ethics and dissemination: </strong>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.</p><p><strong>Highlights: </strong>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.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"55-60"},"PeriodicalIF":0.9,"publicationDate":"2021-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38930290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RETention of urine After INguinal hernia Elective Repair (RETAINER study I and II).","authors":"Stefanie M Croghan,&nbsp;Christina A Fleming,&nbsp;Helen M Mohan,&nbsp;Deena Harji,&nbsp;Jarlath C Bolger,&nbsp;Jessie A Elliott,&nbsp;Michael Boland,&nbsp;Peter E Lonergan,&nbsp;Patrick Dillon,&nbsp;David M Quinlan,&nbsp;Des C Winter","doi":"10.29337/ijsp.137","DOIUrl":"https://doi.org/10.29337/ijsp.137","url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Highlights retainer i & ii protocols: </strong>RETAINER (RETention of urine After INguinal hernia Elective Repair) I is a prospective, multicentre, international observational study.RETAINER I aims to explore the <i>incidence of</i> and <i>risk factors for</i> 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.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"42-54"},"PeriodicalIF":0.9,"publicationDate":"2021-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38930289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial.","authors":"Montse Nuevo,&nbsp;Hadis Mahdavi,&nbsp;Daniel Rodríguez,&nbsp;Teresa Faura,&nbsp;Núria Fabrellas,&nbsp;Simone Balocco,&nbsp;Marco Conti,&nbsp;Alessandro Castagna,&nbsp;Salvi Prat","doi":"10.29337/ijsp.138","DOIUrl":"https://doi.org/10.29337/ijsp.138","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods/design: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Ethics and dissemination: </strong>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.</p><p><strong>Trial registration: </strong>NCT04155957 (ClinicalTrials.gov).</p><p><strong>Highlights: </strong>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.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"34-41"},"PeriodicalIF":0.9,"publicationDate":"2021-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38930288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Novel Mixed-Methods Platform Study Protocol for Investigating New Surgical Devices, with Embedded Shared Learning: Ibra-net Breast Lesion Localisation Study.","authors":"Hannah L Bromley,&nbsp;Rajiv Dave,&nbsp;Chris Holcombe,&nbsp;Shelley Potter,&nbsp;Anthony J Maxwell,&nbsp;Cliona Kirwan,&nbsp;Senthurun Mylvaganam,&nbsp;Suzanne Elgammal,&nbsp;Jenna Morgan,&nbsp;Sue Down,&nbsp;Tahir Masudi,&nbsp;Amtul Sami,&nbsp;Nicola Barnes,&nbsp;James Harvey","doi":"10.29337/ijsp.136","DOIUrl":"https://doi.org/10.29337/ijsp.136","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and analysis: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Registration: &lt;/strong&gt;This is a UK national audit registered with Manchester University NHS Foundation Trust.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Highlights: &lt;/strong&gt;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","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"26-33"},"PeriodicalIF":0.9,"publicationDate":"2021-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114848/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38930287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}