A systematic review on the effectiveness of robot-assisted minimally invasive gastrectomy.

BACKGROUND: Robot-assisted minimally invasive gastrectomy (RAMIG) is increasingly used as a surgical approach for gastric cancer. This study assessed the effectiveness of RAMIG and studied which stages of the IDEAL-framework (1 = Idea, 2A = Development, 2B = Exploration, 3 = Assessment, 4 = Long-term follow-up) were followed. METHODS: The Cochrane Library, Embase, Pubmed, and Web of Science were searched for studies on RAMIG up to January 2023. Data collection included the IDEAL-stage, demographics, number of participants, and study design. For randomized controlled trials (RCTs) and long-term studies, data on intra-, postoperative, and oncologic outcomes, survival, and costs of RAMIG were collected and summarized. RESULTS: Of the 114 included studies, none reported the IDEAL-stage. After full-text reading, 18 (16%) studies were considered IDEAL-2A, 75 (66%) IDEAL-2B, 4 (4%) IDEAL-3, and 17 (15%) IDEAL-4. The IDEAL-stages were followed sequentially (2A-4), with IDEAL-2A studies still ongoing. IDEAL-3 RCTs showed lower overall complications (8.5-9.2% RAMIG versus 17.6-19.3% laparoscopic total/subtotal gastrectomy), equal 30-day mortality (0%), and equal length of hospital stay for RAMIG (mean 5.7-8.5 days RAMIG versus 6.4-8.2 days open/laparoscopic total/subtotal gastrectomy). Lymph node yield was similar across techniques, but RAMIG incurred significantly higher costs than laparoscopic total/subtotal gastrectomy ($13,423-15,262 versus $10,165-10,945). IDEAL-4 studies showed similar or improved overall/disease-free survival for RAMIG. CONCLUSION: During worldwide RAMIG implementation, the IDEAL-framework was followed in sequential order. IDEAL-3 and 4 long-term studies showed that RAMIG is similar or even better to conventional surgery in terms of hospital stay, lymph node yield, and overall/disease-free survival. In addition, RAMIG showed reduced postoperative complication rates, despite higher costs.

First experience with the Hugo™ robot-assisted surgery system for endometriosis: A descriptive study.

INTRODUCTION: The Medtronic Hugo™ Robot-assisted Surgery (RAS) system was recently approved for clinical use. We explored the safety and feasibility of this system for endometriosis surgery. The primary outcome was safe case completion without major surgical complications (Clavien-Dindo grade ≤2) and no conversion to open surgery or laparoscopy. MATERIAL AND METHODS: Surgeries for endometriosis performed at the Department of Gynecology, Rigshospitalet, on the Medtronic Hugo™ RAS system were included. Two experienced robotic surgeons performed all surgeries with their usual robotic team. The variables included were patient demographics, peri- and postoperative data, complications and 30-day readmission rate. We used the IDEAL framework 1/2a for surgical innovation in this descriptive study. RESULTS: The first 12 patients were included. All cases were completed without intraoperative complications or conversion. Four patients experienced Clavien-Dindo grade 1 postoperative complications. No patients were re-admitted within 30 days. Median docking time (17 minutes), console time (87.5 minutes), blood loss (40 mL) and length of hospital stay (1 day) were acceptable compared with previous literature. CONCLUSIONS: In this pilot study, we found the Medtronic Hugo™ RAS system safe and feasible for robot-assisted surgery for endometriosis. The advent of new robotic systems is welcomed to accelerate the development of technology that will advance surgical care for patients across the globe.

Safely Introducing New Surgical Devices in Minimally Invasive Gynecologic Surgery: An Argument for Use of the IDEAL Framework.

OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices. DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers. METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications. TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study. CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance.

Application of the IDEAL framework in hepatopancreatobiliary surgery: a review of the literature.

PURPOSE: To evaluate every stage of surgical innovation and generate high-quality research evidence, the IDEAL (Idea, Development, Exploration, Assessment, Long-term study) framework was developed. This study aimed to explore the application of the IDEAL framework in hepatopancreatobiliary surgery and identify factors limiting its dissemination. METHODS: We conducted a citation search of 8 core IDEAL framework articles in PubMed, Embase, Web of Science, and Scopus databases from 2009 to 2022. Two independent reviewers screened and selected articles related to hepatopancreatobiliary surgery. RESULTS: A total of 1621 articles were identified through citation search. Following screening, 132 articles were finally retained, including 75 original studies (57%) and 57 secondary studies (43%). Of the original studies, only 10 articles (13%) accurately applied the IDEAL framework in methodology, distributed as follows: 1 in pre-IDEAL stage (0), 2 in Idea stage (1), 7 in Development stage (2a), 1 in Exploration stage (2b), and no articles in Assessment and Long-term study stages (3, 4). In the secondary studies, 36 articles (63%) mentioned and discussed the IDEAL framework, and all supported its application. CONCLUSIONS: The application of the IDEAL framework in hepatopancreatobiliary surgery is increasingly widespread, as evidenced by its substantial citation in numerous articles. However, the utilization of the IDEAL framework remains predominantly confined to the early stages of innovation in hepatopancreatobiliary surgery, coupled with instances of misapplication stemming from insufficient comprehension of the framework. Further efforts are necessary to extend the impact of the IDEAL framework and provide surgeons with comprehensive guidance for its judicious implementation.

Implementation of the Versius robotic surgical system for colorectal cancer surgery: First clinical experience.

BACKGROUND: The Versius surgical system, from CMR Surgical, is the first UK-based robotic platform to become commercially available. This is a prospective series in accordance with the IDEAL development framework for surgical innovation reporting the clinical implementation and initial experience using this robotic platform. METHODS: Patients with colorectal cancer were included. Exclusion criteria included T4 tumours, ultra-low rectal cancer and severe comorbidity (American Society of Anesthesiologists grade ≥ 3). Institutional ethical approval was obtained, and patients were counselled preoperatively with informed consent. Patients underwent colorectal resection using the Versius surgical system. Procedures were anticipated as hybrid operations (laparoscopic/robotic) consistent with a proof of concept/technical feasibility study. RESULTS: Main outcome measures included operative time, complication rates and pathological results. Thirty-two patients (15 men) underwent colorectal cancer resections. The mean age was 68 years (27-85 years). Estimated blood loss was 150 ml; range <100 to <500 ml. For right hemicolectomy, the average operative time was 221 min (183-323 min). The average console time was 111 min (64-213 min). For robotic anterior resection, the total operative time was on average 319 min (222-408 min) with an average console time of 204 min (85-242 min). Eight patients experienced Grade II morbidities (22%) with no serious morbidities and no mortalities. Mean return to bowel function was 2.9 days (1-6 days). The average length of stay was 5.3 days with a median of 4 days (2-20 days). All resections were R0 with an average lymph node yield of 20 nodes (8-46 nodes). CONCLUSION: Our initial experience with Versius demonstrates its safe adoption and implementation for colorectal resections.

The IDEAL framework in neurosurgery: a bibliometric analysis.

BACKGROUND: The Idea, Development, Exploration, Assessment and Long-term study (IDEAL) framework was created to provide a structured way for assessing and evaluating novel surgical techniques and devices. OBJECTIVES: The aim of this paper was to investigate the utilization of the IDEAL framework within neurosurgery, and to identify factors influencing implementation. METHODS: A bibliometric analysis of the 7 key IDEAL papers on Scopus, PubMed, Embase, Web of Science, and Google Scholar databases (2009-2019) was performed. A second journal-specific search then identified additional papers citing the IDEAL framework. Publications identified were screened by two independent reviewers to select neurosurgery-specific articles. RESULTS: The citation search identified 1336 articles. The journal search identified another 16 articles. Following deduplication and review, 51 relevant articles remained; 14 primary papers (27%) and 37 secondary papers (73%). Of the primary papers, 5 (36%) papers applied the IDEAL framework to their research correctly; two were aligned to the pre-IDEAL stage, one to the Idea and Development stages, and two to the Exploration stage. Of the secondary papers, 21 (57%) explicitly discussed the IDEAL framework. Eighteen (86%) of these were supportive of implementing the framework, while one was not, and two were neutral. CONCLUSION: The adoption of the IDEAL framework in neurosurgery has been slow, particularly for early-stage neurosurgical techniques and inventions. However, the largely positive reviews in secondary literature suggest potential for increased use that may be achieved with education and publicity.

Conceptualising Surgical Innovation: An Eliminativist Proposal.

Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (surgical) innovation, that we categorised alliteratively under the themes of "purpose" (about drivers of innovation), "place" (about contexts of innovation), "process" (about differentiating innovation), "product" (about tangible and intangible results of innovation) and "person" (about personal factors and viewpoint). These conceptual areas are used in varying-sometimes contradictory-ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term "innovation" carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term "innovation" from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery.

Evolution of the surgical technique of minimally invasive Ivor-Lewis esophagectomy: description according to the IDEAL framework.

Totally minimally invasive Ivor-Lewis esophagectomy (Ivor Lewis TMIE) is a technically challenging procedure and is associated with a learning curve. Refinement of surgical technique is an important part of this learning curve. However, detailed descriptions of these refinements according to the idea, development, exploration, assessment, and long-term follow-up (IDEAL) framework are lacking and this study was undertaken to fill this knowledge gap. From 2010 until 2016, all consecutive patients (n = 164) were included from the first patient undergoing Ivor Lewis TMIE. Surgical reports were analyzed and surgeons were interviewed to determine surgical refinements. These data were used to describe the transition of the surgical technique from IDEAL stage IIB to stage III. The main findings were that four refinements were made to the surgical procedure in IDEAL stage IIB: (1) At case 9, the use of the 25 mm OrVil was abandoned, exchanged for a 28 mm EEA stapler and a large omental wrap around the anastomosis was introduced; (2) at case 27, the omental wrap was reduced in volume; (3) at case 60, the omental wrap was refined to cover the full 360° of the anastomosis and (4) at case 77, the fixation of the anvil with the Endostitch was replaced by fixation with two Endoloops®. During the transition from IDEAL stage IIB to stage III, the incidence of anastomotic leakage decreased from 26.0% to 4.6% (P < 0.001) and the incidence of textbook outcome increased from 31.2% to 47.1% (P = 0.039). In conclusion, this study describes the surgical refinements that were made during the progression of Ivor Lewis TMIE from IDEAL stage IIB to IDEAL stage III. During IDEAL stage IIB, postoperative outcome improved as surgical proficiency was gained and the technique was refined.

Innovation in neurosurgery: less than IDEAL? A systematic review.

BACKGROUND: Surgical innovation is different from the introduction of novel pharmaceuticals. To help address this, in 2009 the IDEAL Collaboration (Idea, Development, Exploration, Assessment, Long-term follow-up) introduced the five-stage framework for surgical innovation. To evaluate the framework feasibility for novel neurosurgical procedure introduction, two innovative surgical procedures were examined: the endoscopic endonasal approach for skull base meningiomas (EEMS) and the WovenEndobridge (WEB device) for endovascular treatment of intracranial aneurysms. METHODS: The published literature on EEMS and WEB devices was systematically reviewed. Identified studies were classified according to the IDEAL framework stage. Next, studies were evaluated for possible categorization according to the IDEAL framework. RESULTS: Five hundred seventy-six papers describing EEMS were identified of which 26 papers were included. No prospective studies were identified, and no studies reported on ethical approval or patient informed consent for the innovative procedure. Therefore, no clinical studies could be categorized according to the IDEAL Framework. For WEB devices, 6229 articles were screened of which 21 were included. In contrast to EEMS, two studies were categorized as 2a and two as 2b. CONCLUSION: The results of this systematic review demonstrate that both EEMS and WEB devices were not introduced according to the (later developed in the case of EEMS) IDEAL framework. Elements of the framework such as informed consent, ethical approval, and rigorous outcomes reporting are important and could serve to improve the quality of neurosurgical research. Alternative study designs and the use of big data could be useful modifications of the IDEAL framework for innovation in neurosurgery.

Expanding indications and regional diversity in laparoscopic liver resection unveiled by the International Survey on Technical Aspects of Laparoscopic Liver Resection (INSTALL) study.

BACKGROUND: Laparoscopic liver resection (LLR) has undergone widespread dissemination after the first international consensus conference in 2008, and specialized centers continue to report remarkable achievements. However, little is known about the global adoption of LLR. This study aimed to illuminate geographical variances in the indications and technical aspects of LLR and to delineate the evolution of this approach worldwide. METHODS: In advance of the Second International Consensus Conference in Morioka, Japan, a web-based, anonymous questionnaire comprising 46 questions, named the International Survey on Technical Aspects of Laparoscopic Liver Resection study, was sent via e-mail to the members of regional and International Hepato-Pancreato-Biliary Association offices. The results of the 13 questions concerning the global diffusion of LLR have been reported previously. Responses to the remaining 33 questions that corresponded to indications and surgical techniques used in LLR were collected and analyzed. RESULTS: Survey responses were received from 412 LLR surgeons in 42 countries on five continents. The majority of surgeons in North America had no restrictions on the maximum size or number of tumors to be resected laparoscopically. Likewise, >50 % of surgeons in East Asia and North America performed LLR for the postero-superior 'difficult' segments. Major resection was performed in 40 to >60 % of centers in North America, Europe, and East Asia. Donor hepatectomy was performed only in specialized centers. More than 75 % of respondents had adopted a pure laparoscopic approach. A flexible laparoscope was most commonly used in East Asia. Most surgeons used pneumoperitoneal pressure at around 9-16 mmHg. Other techniques and devices were used at the discretion of each surgeon. CONCLUSIONS: Indications for LLR continue to expand with some regional diversity. Surgical approaches and devices used in LLR are a matter of preference and availability, as in open liver resection.

IDEAL monitoring of musical skills during awake craniotomy: From step 1 to step 2.

The aim of awake brain surgery is to perform a maximum resection on the one hand, and to preserve cognitive functions, quality of life and personal autonomy on the other hand. Historically, language and sensorimotor functions were most frequently monitored. Over the years other cognitive functions, including music, have entered the operation theatre. Cases about monitoring musical abilities during awake brain surgery are emerging, and a systematic method how to monitor music would be the next step. According to the IDEAL framework for surgical innovations our study aims to present future recommendation based on a systematic literature search (PRISMA) in combination with lessons learned from three case reports from our own clinical practice with professional musicians (n = 3). We plead for structured procedures including individual tailored tasks. By embracing these recommendations, we can both improve clinical care and unravel music functions in the brain.

Skills transfer from the DaVinci® system to the Hugo™ RAS system.

PURPOSE: Recently, the robotic surgical system, Hugo™ was approved for clinical use. The transfer of skills is important for understanding the implementation of surgical innovation. We explored the transfer of skills from the DaVinci® to the Hugo™ by studying the learning curve and short-term patient outcomes during radical prostatectomy (RARP). METHODS: We examined the transfer of skills from one surgeon performing RARP from the first case with the Hugo™ system in April 2022. The surgeon had previously performed > 1000 RARPs using DaVinci®. Perioperative and clinical outcomes were collected for procedures on both Hugo™ and DaVinci®. Patient follow-up time was 3 months. RESULTS: Nineteen Hugo™ cases and 11 DaVinci® cases were recorded. No clinically relevant difference in procedure time was found when transferring to Hugo™. Patients operated using Hugo™ had more contacts postoperatively compared to the DaVinci®, all Clavien-Dindo (CD) grade 1 (53% vs 18%). Three patients from the Hugo™ group were re-admitted within 30 days with catheter malfunction (CD grade 1), infection without a focus (CD grade 2), and ileus due to a hernia in the port hole (CD grade 3b). The 3-month follow-up showed similar results in prostate-specific antigen levels (PSA) and erectile dysfunction between the two robotic systems, but a higher incidence of incontinence was found for the Hugo™. CONCLUSION: We observed that the skills of an experienced robotic surgeon are transferable from DaVinci® to Hugo™ when performing RARP. No obvious benefits were found for using Hugo™ compared to DaVinci® for RARP although this needs confirmatory studies.

A Systematic Review to Summarise and Appraise the Reporting of Surgical Innovation: a Case Study in Robotic Roux-en-Y Gastric Bypass.

Robotic Roux-en-Y gastric bypass (RRYGB) is an innovative alternative to traditional laparoscopic approaches. Literature has been published investigating its safety/efficacy; however, the quality of reporting is uncertain. This systematic review used the Idea, Development, Exploration, Assessment and Long-term follow-up (IDEAL) framework to assess the reporting quality of available literature. A narrative summary was formulated, assessing how comprehensively governance/ethics, patient selection, demographics, surgeon expertise/training, technique description and outcomes were reported. Forty-seven studies published between 2005 and 2024 were included. There was incomplete/inconsistent reporting of governance/ethics, patient selection, surgeon expertise/training and technique description, with heterogenous outcome reporting. RRYGB reporting was poor and did not align with IDEAL guidance. Robust prospective studies reporting findings using IDEAL/other guidance are required to facilitate safe widespread adoption of RRYGB and other surgical innovations.

A systematic review of robot-assisted anti-reflux surgery to examine reporting standards.

Robot-assisted anti-reflux surgery (RA-ARS) is increasingly being used to treat refractory gastro-oesophageal reflux disease. The IDEAL (Idea, Development, Exploration, Assessment, Long-term follow up) Collaboration's framework aims to improve the evaluation of surgical innovation, but the extent to which the evolution of RA-ARS has followed this model is unclear. This study aims to evaluate the standard to which RA-ARS has been reported during its evolution, in relation to the IDEAL framework. A systematic review from inception to June 2020 was undertaken to identify all primary English language studies pertaining to RA-ARS. Studies of paraoesophageal or giant hernias were excluded. Data extraction was informed by IDEAL guidelines and summarised by narrative synthesis. Twenty-three studies were included: two case reports, five case series, ten cohort studies and six randomised controlled trials. The majority were single-centre studies comparing RA-ARS and laparoscopic Nissen fundoplication. Eleven (48%) studies reported patient selection criteria, with high variability between studies. Few studies reported conflicts of interest (30%), funding arrangements (26%), or surgeons' prior robotic experience (13%). Outcome reporting was heterogeneous; 157 distinct outcomes were identified. No single outcome was reported in all studies.The under-reporting of important aspects of study design and high degree of outcome heterogeneity impedes the ability to draw meaningful conclusions from the body of evidence. There is a need for further well-designed prospective studies and randomised trials, alongside agreement about outcome selection, measurement and reporting for future RA-ARS studies.

Evaluating the Development Status of Fluorescence-Guided Surgery (FGS) in Pediatric Surgery Using the Idea, Development, Exploration, Assessment, and Long-Term Study (IDEAL) Framework.

Fluorescence-guided surgery (FGS) is used in many pediatric subspecialties but there are currently no standard guidelines or outcome data. We aimed to assess the current status of FGS in pediatrics using the Idea, Development, Exploration, Assessment, and Long-term study (IDEAL) framework. Clinical papers on FGS in children published from January 2000 to December 2022 were systematically reviewed. The stage of research development was measured considering seven fields of application: biliary tree imaging, vascular perfusion for gastrointestinal procedures, lymphatic flow imaging, tumor resection, urogenital surgery, plastic surgery, and miscellaneous procedures. Fifty-nine articles were selected. For each field of application, the overall IDEAL stage was determined to be 2a for biliary tree imaging (10 publications, 102 cases), 1 for vascular perfusion for gastrointestinal procedures (8 publications, 28 cases), 1 for lymphatic flow imaging (12 publications, 33 cases), 2a for tumor resection (20 publications, 238 cases), 2a for urogenital surgery (9 publications, 197 cases), and 1-2a for plastic surgery (4 publications, 26 cases). One report did not belong to any categories. FGS in children is still in an early phase of adoption and development. We recommend using the IDEAL framework as a guide and suggest developing multicenter studies to define the standard guidelines, effectiveness, and outcomes.

Treatment of Hidradenitis Suppurativa Evaluation Study: the THESEUS prospective cohort study.

Background: Hidradenitis suppurativa is a chronic inflammatory skin disease characterised by recurrent inflammatory lesions and skin tunnels in flexural sites such as the axilla. Deroofing of skin tunnels and laser treatment are standard hidradenitis suppurativa interventions in some countries but not yet introduced in the United Kingdom. Objective: To understand current hidradenitis suppurativa management pathways and what influences treatment choices to inform the design of future randomised controlled trials. Design: Prospective 12-month observational cohort study, including five treatment options, with nested qualitative interviews and an end-of-study consensus workshop. Setting: Ten United Kingdom hospitals with recruitment led by dermatology and plastic surgery departments. Participants: Adults with active hidradenitis suppurativa of any severity not adequately controlled by current treatment. Interventions: Oral doxycycline 200 mg once daily; oral clindamycin and rifampicin, both 300 mg twice daily for 10 weeks initially; laser treatment targeting the hair follicle (neodymium-doped yttrium aluminium garnet or alexandrite); deroofing; and conventional surgery. Main outcome measures: Primary outcome was the proportion of participants who are eligible, and hypothetically willing, to use the different treatment options. Secondary outcomes included proportion of participants choosing each of the study interventions, with reasons for their choices; proportion of participants who switched treatments; treatment fidelity; loss to follow-up rates over 12 months; and efficacy outcome estimates to inform outcome measure instrument responsiveness. Results: Between February 2020 and July 2021, 151 participants were recruited, with two pauses due to the COVID-19 pandemic. Follow-up rates were 89% and 83% after 3 and 6 months, decreasing to 70% and 44% at 9 and 12 months, respectively, because pandemic recruitment delays prevented all participants reaching their final review. Baseline demographics included an average age of 36 years, 81% female, 20% black, Asian or Caribbean, 64% current or ex-smokers and 86% with a raised body mass index. Some 69% had moderate disease, 19% severe disease and 13% mild disease. Regarding the study's primary outcome, laser treatment was the intervention with the highest proportion (69%) of participants who were eligible and hypothetically willing to receive treatment, followed by deroofing (58%), conventional surgery (54%), the combination of oral clindamycin and rifampicin (44%) and doxycycline (37%). Considering participant willingness in isolation, laser was ranked first choice by the greatest proportion (41%) of participants. The cohort study and qualitative study demonstrated that participant willingness to receive treatment was strongly influenced by their clinician. Fidelity to oral doxycycline was only 52% after 3 months due to lack of effectiveness, participant preference and adverse effects. Delays receiving procedural interventions were common, with only 43% and 26% of participants commencing laser therapy and deroofing, respectively, after 3 months. Treatment switching was uncommon and there were no serious adverse events. Daily pain score text messages were initiated in 110 participants. Daily responses reduced over time with greatest concordance during the first 14 days. Limitations: It was not possible to characterise conventional surgery due to a low number of participants. Conclusion: The Treatment of Hidradenitis Suppurativa Evaluation Study established deroofing and laser treatment for hidradenitis suppurativa in the United Kingdom and developed a network of 10 sites for subsequent hidradenitis suppurativa randomised controlled trials. Future work: The consensus workshop prioritised laser treatment and deroofing as interventions for future randomised controlled trials, in some cases combined with drug treatment. Trial registration: This trial is registered as ISRCTN69985145. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/35/64) and is published in full in Health Technology Assessment; Vol. 27, No. 30. See the NIHR Funding and Awards website for further award information.

The Treatment of Hidradenitis Suppurativa Evaluation Study introduced deroofing of skin tunnels and laser treatment for hidradenitis suppurativa and found that these are preferred interventions for future trials compared with oral antibiotics or conventional surgery.

[Dissection borders of laparoscopic lower mediastinal lymphadenectomy for adenocarcinoma of esophagogastric junction and the quality control].

The lower mediastinal lymphadenectomy is indicated for adenocarcinoma of esophagogastric junction (AEG), while the laparoscopic procedure shows some advantages. According to previous studies and results of IDEAL phase 2a study in our institute, the following structures are recommended as the dissection borders: the upper (cranial) is inferior wall of pericardium and pulmonary ligament; the lower (caudal) is diaphragm hiatus (esophagogastric junction); the front (ventral) is anterior inferior wall of pericardium and diaphragm; the back (dorsal) is anterior wall of aorta; the lateral is mediastinal pleura. The standard of quality control is still under investigation.

[Standards of surgical clinical researches: Introduction of IDEAL framework].

Many breakthroughs in the field of surgical clinical researches have been achieved in China, but the overall quality is relatively limited, largely because of the insufficiency in standardization, rationality and scientificity of methodology. In consideration of the nature of surgical procedures and equipments, it is necessary to establish a set of methodological system, suitable for the high-quality clinical research in the surgical field. IDEAL collaboration has put forward a systematic methodological framework for innovation in surgical procedure and equipment. For the clinical research on surgical innovation, the IDEAL framework can be divided into five sequential stages, namely, Idea, Development, Exploration, Assessment and Long-term follow-up. In different stages, the difficulties to be faced, the problems to be solved, and the research design to be adopted are diverse and progressive. Although the IDEAL framework is not perfect, it is currently the best framework for surgical clinical research. While performing surgical clinical research, we should continue to think about how to improve the surgical clinical research methodology.

Development of sentinel lymph node biopsy technique in patients with salivary gland cancer using the IDEAL framework.

BACKGROUND: Salivary cancer is rare and comprises a variety of histological subtypes and clinical behaviors. There is no agreed method of estimating the risk of occult metastasis or managing the clinically N0 neck.Sentinel node biopsy (SNB) may offer a solution but previous studies have not produced a reliable imaging protocol. This study uses novel technology and trial methodology to develop a reliable SNB technique, with primary aim to identify peri-and intraglandular sentinel nodes. METHODS: IDEAL framework was used to undertake SNB in clinically node negative salivary gland cancer. Patients with cT1-2 N0 salivary cancer were eligible. Lymphoscintigraphy was undertaken using Tc-99 m labelled nanocoll. Injection technique as well as adjunctive use of freehand SPECT (fhSPECT), near-infrared (NIR) fluorescence imaging, and navigation-guided surgery were used and optimisied during the study protocol. RESULTS: 10 patients were recruited. Initial protocol of peritumoural injection of Tc99 m nanocoll showed poor image resolution. Subsequent adjustment to single intratumoural injection allowed identification of intraglandular sentinel nodes. Fh/SPECT and NIR fluorescence imaging found intraglandular lymph nodes otherwise not recognizable to the naked eye. In two cases occult lymph node metastasis were identified. CONCLUSION: This study has shown the IDEAL framework is vital in allowing iterative changes in surgical protocol in the light of experience. This study has produced a reliable method for detection of sentinel nodes, in particular the ability to identify intra- and periglandular nodes with diagnosis of occult metastatic deposits and no false negative results. Our protocol can be readily transferred in to larger scale studies.

IDEAL framework in surgical innovation applied on laparoscopic niche repair.

The research objective of the current systematic literature review is to classify the laparoscopic niche repair according to the IDEAL framework of 'innovation stages' and to recommend the required research setting to facilitate safe and properly timed implementation of the technique. In doing so, we are also able to evaluate the practical applicability of the IDEAL framework. A systematic search of the available literature on laparoscopic niche repair was performed in PubMed, Embase, and the Wiley/Cochrane library. Articles were classified according to the IDEAL framework and recommendations were given on additional required research before the technique can be safely implemented. Practical applicability of the IDEAL framework was also evaluated. Introduction of laparoscopic niche repair matches Idea (1) and Development (2a), according to the stages of IDEAL framework, although most studies are retrospective and complications have not been registered structurally in a considerable number of the articles. As feasibility and safety have been more or less established and surgery has been further developed we enter stage 2b (Exploration) and need prospective trials preferably comparing the effectiveness of laparoscopic niche repair to expectant management, the current standard care. Available studies were classified with the use of the IDEAL framework, achieving an overall IDEAL stage to be 2a Development. As clinical outcomes, though poorly registered, have been substantially improved, laparoscopic niche repair needs to be carried forward by more advanced study designs.