International Journal of Surgery Protocols最新文献

Background: Neurogenic thoracic outlet syndrome (NTOS), characterized by brachial plexus compression, causes chronic pain and numbness in the upper extremities. Recurrences are common after surgical treatment, which typically includes an anterior scalenectomy and rib resection. Brachial plexus neurolysis and flap coverage can reduce scar fibrosis and prevent further recurrence. The latissimus dorsi flap is a common choice for this purpose. However, perforator fat flaps minimize donor site complications by avoiding muscle harvesting. Furthermore, a free flap transfer prevents new scars from developing in an already painful anatomical region. Given the lack of literature on this subject, we plan to use validated and recommended questionnaires to investigate the impact on pain and quality of life of brachial plexus wrapping with a free fat flap following neurolysis in cases of recurrent NTOS.

Methods: FIRST is a single-center, prospective observational pilot study recruiting participants over 24 months. Eligible patients over the age of 18 are treated with brachial plexus neurolysis and a free perforator fat flap for recurrent NTOS. The study aims to enroll 20 patients and involves preoperative and postoperative assessments at a six-month follow-up. The primary outcome, measured using numerical scales, is pain reduction. Secondary outcomes include decreased painful body surface area, maximum and average pain levels, changes in quality of life, upper limb function, and anxiety-depressive symptoms, which are measured using various validated scales and questionnaires.

Discussion: This study will provide insight into the efficacy of free perforator fat flaps in recurrent NTOS using standardized, validated assessments for neuropathic pain, including psychosocial aspects. By providing vascularization around the brachial plexus, fat flaps may reduce inflammation, fibrosis, and perineural scar adhesions, thereby alleviating pain. This technique also avoids extensive local dissection required for regional flaps and reduces donor site morbidity. Potential limitations include the technical complexity of free flap surgery.

Background: Over the past decade, post-mastectomy radiotherapy (PMRT) is indicated more frequently in breast cancer treatment, especially in patients with involved axillary lymph nodes. However, PMRT is associated with high complication rates and less satisfactory cosmetic results when combined with immediate breast reconstructions. This has led to ongoing controversy regarding breast reconstruction and radiotherapy, often postponing the reconstruction until long after PMRT has been completed. Preoperative radiotherapy, also known as neoadjuvant radiotherapy (NART), is emerging as a safe and promising alternative with the potential to allow immediate reconstruction without the negative effects of radiotherapy on the reconstructed breast. However, data on the complication rates and patient-reported outcomes (PROs) after NART followed by mastectomy and breast reconstruction are still limited.

Methods: This is a multicenter, prospective, single-arm pilot study including breast cancer patients requiring mastectomy and PMRT, who desire immediate breast reconstruction, either implant-based or autologous. The primary objective is to assess complications three months after the last planned reconstructive surgery. The secondary objectives are to evaluate patient-reported health-related quality of life (HR-QoL), patient- and physician-reported cosmetic results, and pathological response.

Discussion: The primary outcome of this pilot study is to provide further evidence to determine whether NART is a viable alternative to PMRT in terms of complication rates when combined with immediate breast reconstruction. The secondary outcomes will enhance our understanding of patients' HR-QoL and cosmetic outcomes. If NART proves to be a safe alternative, this pilot study will lay the foundation for a national multicenter randomized controlled trial to evaluate long-term HR-QoL and oncological outcomes.

Background: Fat embolism (FE), traditionally associated with orthopedic trauma, is increasingly recognized in non-orthopedic procedures such as fat grafting, liposuction, and organ transplantation. The variability in clinical presentation and diagnostic challenges in these contexts highlights the need for a standardized reporting framework.

Methods: The protocol is based on findings from three systematic reviews and a comprehensive literature review, encompassing 187 cases of fat embolism in non-orthopedic settings. The proposed framework includes guidelines on patient demographics, procedural characteristics, symptom onset, clinical presentation, diagnostic methods, management strategies, and outcomes.

Results: The proposed protocol aims to standardize the documentation of key factors in non-orthopedic fat embolism cases, facilitating improved case reporting and research. Key components include patient details, procedural descriptions, symptom timing, clinical signs, diagnostic approaches, and treatment protocols.

Conclusion: A standardized reporting protocol for non-orthopedic fat embolism will enhance clinical recognition, improve management strategies, and contribute to better patient outcomes. Further validation through prospective studies is needed to refine and expand this framework.

Introduction: The advent of bariatric surgery as a widespread intervention is paralleled by comprehensive data capture in bariatric registries following elective surgery. However, significant challenges hinder tracking the incidence and nature of severe complications in the context of bariatric surgery. As the prevalence of bariatric procedures escalates, the establishment of a dedicated, prospective complication registry becomes imperative. Such an initiative would facilitate a nuanced understanding of bariatric surgical emergency (BSE) within the current healthcare milieu, enhance economic evaluations, elucidate long-term patient outcomes, and inform requisite adjustments in professional training. This study is designed to capture and assess the ramifications of emergency bariatric surgical practices within the United Kingdom.

Methods and analysis: We propose a prospective, multi-center, audit of emergency bariatric surgical activity in all UK hospitals. Eligible participants are those who undergo any intervention or procedure (surgical or endoscopic) to diagnose or treat BSE. Primary outcome measures will include hospital length of stay, rates of complications (Clavien-Dindo), and 30-D mortality. Secondary outcomes will assess the broader impacts and patterns of care, including variations in practice and resource utilization across the nation, rates of outpatient follow-up, and the frequency of subsequent procedures (surgical or endoscopic) post-BSE. Additionally, the study will investigate potential predictors for patients' choice between state-funded and self-pay bariatric surgery options, considering factors such as ethnicity and previous engagement with NHS-specialized weight loss pathways.

Ethics and dissemination: This study will be registered as clinical audit at each participating hospital. The protocol will be disseminated through the British Obesity and Metabolic Surgery Society network and using a targeted social media-based strategy in the UK.

Background: Rheumatic heart disease (RHD) remains a major health challenge in Africa, where the prevalence is notably high. Valvular surgery is a crucial procedure for managing severe RHD. However, the current state and historical trend of research on this subject in African populations is not well understood. Understanding the scope, subject matter, and quality of the literature on this topic over time is essential to inform future research and clinical practice.

Objective: This paper aims to assess the current published literature to evaluate vital outcomes such as surgical outcomes, survival rates, postoperative complications, long-term quality of life, morbidities, mortalities, and barriers to valve surgery for patients with RHD in Africa.

Methods: This protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). An extensive search will be conducted across different databases, including PubMed, Scopus, Web of Science, Cochrane Library, African Index Medicus, and African Journals Online. Studies will be identified through keyword searches and will be reviewed against predefined inclusion and exclusion criteria by two reviewers, with a third reviewer resolving any discrepancies. A narrative synthesis will be conducted to describe the findings.

Conclusion: The findings from this scoping review will provide an understanding of the current literature on valvular surgery for RHD in African contexts. This will help guide future research directions in this field.

Background: Optimal extent of lymph node dissection for colon cancer is debatable. Extensive lymphadenectomy may increase complication rate, while limited lymph node dissection may compromise oncological outcome. One of promising ways to find balance is to tailor extent of lymph node dissection to patient's individual anatomy using ICG lymphatic mapping.

Methods: This is a single center interventional phase II trial with single group assignment aiming to determine if ICG lymphatic mapping sensitivity is sufficient to guide resection margins selection in colon cancer surgery. The trial's primary endpoint is proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG spread. Sample size of 101 patients was calculated using Buderer method ^[19] with a confidence level (1 - α) of 0.95 as a minimum of cases required to test accuracy of lCG lymphatic mapping for estimated sensitivity of 0.99 and precision of 0.03. The average of pN+ cases in our center (42%) was used as prevalence. Secondary endpoints are incidence of adverse events related to ICG lymphatic mapping, feasibility of ICG lymphatic mapping for colon cancer, incidence of lymph node metastases outside conventional resection margins (10 cm), colon cancer lymphatic spread patterns, proportion of operations which extent is affected by ICG lymphatic mapping. The trial is conducted among female or male patients, 18 years or older, with signed informed consent, and diagnosed primary colon cancer. Inclusion criteria include pathologically confirmed adenocarcinoma of the colon, T1-4aN0-2bM0-1b, clinical indications to colonic resection, ECOG - 0-2. Exclusion criteria consist of acute bowel obstruction, bleeding or perforation, adjacent organ invasion or peritoneal carcinomatosis, and contraindications to ICG administration. Eligible patients are allocated for colonic resection with intraoperative ICG mapping. During pathological examination, lymph nodes are assessed for presence of metastases and location in relation to tumor and fluorescence margins. The study began on 26 July 2022 and is conducted in and financed by N.N. Petrov NMRC of Oncology in Saint Petersburg, Russia, it is conducted in.

Results: If after 101 ICG lymphatic mapping procedures, sensitivity of >96% is observed, this will provide rationale behind tailoring resection margins to fit ICG spread.

Conclusions: ICG lymphangiography allows a surgeon to see locoregional lymphatics of a tumor site in real time and tailor colon and mesentery resection margins to meet oncological and functional needs. More data is needed to make this approach more widespread.

Purpose: This planned scoping review aims to map the current knowledge on preoperative risk factors associated with anastomotic leakage following colorectal cancer surgery.

Methods: The review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extensions for Scoping Reviews guidelines. The search will be conducted using MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases. Additionally, we will include grey literature sources. Only original studies examining a risk factor for anastomotic leakage will be included. Data will be charted based on trial characteristics, demographic data, population size, the investigated risk factors, and potential interventions.

Results: The structured overview will be presented as a narrative summary with supplementary statistics.

Conclusion: This protocol describes the methodology for a scoping review which aims to map primary research on preoperative risk factors for anastomotic leakage following colorectal surgery. By systematically collecting and presenting the existing evidence, this review seeks to identify key findings and highlight research gaps to guide clinicians and researchers.

Background: After robot-assisted laparoscopic radical prostatectomy (RARP) for localized prostate cancer, post-operative stress urinary incontinence (SUI) impacts patient quality-of-life (QOL). A simple and less invasive treatment for SUI in these patients is urgently needed. Deflux is a viscous gel that consists of a mixture of sodium hyaluronate and dextranomer beads. It is administered by transurethral approach for the treatment of vesicoureteral reflux. In this study, we aim to establish a minimally invasive treatment for post-prostatectomy SUI through transurethral Deflux injection.

Methods: We will perform a single-center, exploratory clinical trial to evaluate the safety and efficacy of transurethral injection of Deflux for SUI after RARP. Inclusion criteria are patients with SUI, a urine leakage volume between 15 and 500 g in a 24-h pad test, and those who use more than two pads per day. Five patients are scheduled to be enrolled in this pilot study. Deflux is injected endoscopically at the 3 o'clock and 9 o'clock positions in the submucosa until coaptation of submucosal bulking is achieved from both intraurethral sides. The primary endpoint is safety following Deflux injection. The secondary endpoint is efficacy on both SUI volume and patients' QOL.

Discussion: The importance of this clinical trial is to propose a new minimally invasive treatment option for male SUI patients after RARP.

Background: Understanding the metastatic risks and patterns of colon cancer is crucial for patient evaluation and decision-making. However, high-quality evidence on colon cancer metastases is lacking. This study aims to conduct a systematic review and meta-analysis to determine the risk of site-specific metastasis and provide a complete profiling of distant metastasis in colon cancer.

Methods: This review will include studies reporting the proportion of different-site metastases among colon cancer patients. Clinical trials, follow-up studies, and cross-sectional surveys with English publications are eligible for inclusion. We will search Medline, Embase, Web of Science, and the Cochrane Library from inception to June 2023. Two reviewers will independently screen the title/abstract and full texts of identified records according to the eligibility criteria. Data from eligible studies will be extracted and used for meta-analysis. Meta-analyses will be conducted to estimate the overall proportion of site-specific metastasis. During meta-analyses, two proportions will be analyzed, i.e., the incidence of metastasis and component proportion. We will select the appropriate tools to assess the risk of biases based on the study design of included studies.

Results: This study is still in preparation for launch. Once all analyses are complete, the results will be submitted for publication in a peer-reviewed journal.

Conclusion: This review will provide a clear and systematic metastatic pattern of colon cancer and evidence-based recommendations for the management of distant metastasis.

Introduction: Minimally invasive ventral hernia repair (MIVHR) is a frequently performed surgical procedure to address primary or incisional ventral hernias and is recommended by numerous societies. Various techniques are available for MIVHR, including the intraperitoneal onlay mesh (IPOM) procedure and the enhanced view totally extraperitoneal (eTEP) approach. While both techniques are increasingly applied, they continue to be subject of controversy in literature. Well-designed randomized controlled trials comparing both procedures are lacking. The objective of this study is to investigate whether eTEP is associated with a decreased level of postoperative pain compared to IPOM.

Methods: This is a prospective, multi-center, randomized, and blinded controlled trial. Patients presenting with primary or incisional epigastric, umbilical, or infraumbilical hernia with a transverse diameter >1 cm and ≤4 cm, or multiple hernias with a cumulative transverse diameter ≤4 cm, will be randomly assigned to undergo either IPOM or eTEP procedures. All patients and assessors of the study outcomes are blinded to the treatment allocation. The trial will be conducted at the St. Clara Hospital Basel, at the University Hospital Basel (Switzerland) and at the Innklinikum Altötting (Germany). It remains open for additional sites to be included. The multi-center design is chosen to minimize environmental bias related to perioperative anesthesiology and nursing care and to enhance participant recruitment. The primary outcome of this study is to evaluate postoperative pain (numeric rating scale and Patient-Reported Outcome Measurement Information System Pain Intensity Short Form 3a) 24 hours after the surgical procedure. Secondary outcomes include the assessment of pain at different times, length of hospital stay, operative time, readmission rate, intraoperative, and postoperative adverse events.