Laparoscopic pancreatoduodenectomy combined with a novel self-assessment system and feedback discussion: a phase 1 surgical trial following the IDEAL guidelines

Inoue, Yosuke; Saiura, Akio; Sato, Takafumi; Ishizawa, Takeaki; Arita, Junichi; Takahashi, Yu; Hiki, Naoki; Sano, Takeshi; Yamaguchi, Toshiharu

doi:10.1007/s00423-016-1466-4

Cited by 6 publications

(6 citation statements)

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“…Although there is a lack of randomized trials in the field of minimally invasive pancreatic head resections, a growing number of case series and cohort studies have been published comparing the safety and efficacy of minimally invasive and open pancreatic head resection [4]. In many centers performing laparoscopic or robotic pancreatic head resections, these procedures are in fact not minimally invasive pancreatoduodenectomies (MIPD) but rather cases in which the dissection is being performed in a minimally invasive manner, while anastomoses are performed manually [5–9]. This could potentially create a bias in the analysis of outcomes.…”

Section: Introductionmentioning

confidence: 99%

Minimally invasive versus open pancreatoduodenectomy—systematic review and meta-analysis

Pędziwiatr

Małczak

Pisarska

et al. 2017

Langenbecks Arch Surg

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PurposeThe purpose of this systematic review was to compare minimally invasive pancreatoduodenectomy (MIPD) versus open pancreatoduodenectomy (OPD) by using meta-analytical techniques.MethodologyMedline, Embase, and Cochrane Library were searched for eligible studies. Data from included studies were extracted for the following outcomes: operative time, overall morbidity, pancreatic fistula, delayed gastric emptying, blood loss, postoperative hemorrhage, yield of harvested lymph nodes, R1 rate, length of hospital stay, and readmissions. Random and fix effect meta-analyses were undertaken.ResultsInitial reference search yielded 747 articles. Thorough evaluation resulted in 12 papers, which were analyzed. The total number of patients was 2186 (705 in MIPD group and 1481 in OPD). Although there were no differences in overall morbidity between groups, we noticed reduced blood loss, delayed gastric emptying, and length of hospital stay in favor of MIPD. In contrary, meta-analysis of operative time revealed significant differences in favor of open procedures. Remaining parameters did not differ among groups.ConclusionOur review suggests that although MIPD takes longer, it may be associated with reduced blood loss, shortened LOS, and comparable rate of perioperative complications. Due to heterogeneity of included studies and differences in baseline characteristics between analyzed groups, the analysis of short-term oncological outcomes does not allow drawing unequivocal conclusions.Electronic supplementary materialThe online version of this article (doi:10.1007/s00423-017-1583-8) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Minimally invasive versus open pancreatoduodenectomy—systematic review and meta-analysis

Pędziwiatr

Małczak

Pisarska

et al. 2017

Langenbecks Arch Surg

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“…This included the ‘evolution of the new method’, 68 describing the procedure as ‘still under development’. 69 10 (21%) papers described changes based on their experience, for example, ‘from case 35 onward’, 61 ‘based on the results of patient 1’ 54 and ‘thereafter we noticed’. 58 These tended to appear in stage 2a (n=4) and stage 1 (n=3) studies.…”

Section: Resultsmentioning

confidence: 99%

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

Richards,

Cousins,

Scroggie

et al. 2024

BMJ Open

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ObjectivesThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.DesignSecondary qualitative analysis of a systematic review.Data sourcesCitation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.Eligibility criteriaStudies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.Data extraction and synthesisAll relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.Results48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.ConclusionIdentifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors’ rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making.

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Section: Resultsmentioning

confidence: 99%

“…Initial screening identified 62 of 136 records (45·6 per cent) for full‐text eligibility assessment. Finally, 48 relevant publications (42 study reports, 6 protocols) were included in the analysis 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 ( Fig . 1 ).…”

Section: Resultsmentioning

confidence: 99%

“…Further outcomes categorized under this domain included descriptions of problematic points in undertaking the procedure and impressions of the learning experience. Although 23 studies included outcomes relating to surgeon or operator experiences, only three 33 , 45 , 58 reported that experiences were assessed using a formal process (including a rating scale/score, questionnaire and discussion in review meetings between cases). There was a slight trend for surgeon/operator experiences to be measured/reported in studies in the earlier stages of the innovation lifecycle (IDEAL stage 1 and 2a).…”

Section: Resultsmentioning

confidence: 99%

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Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

et al. 2020

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Background: Outcome selection, measurement and reporting for the evaluation of new surgical procedures and devices is inconsistent and lacks standardization. A core outcome set may promote the safe and transparent evaluation of surgical innovations. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) framework to examine current practice and inform the development of a core outcome set for early-phase studies of surgical procedures/devices. Methods: Web of Science and Scopus citation searches were performed to identify author-reported IDEAL/IDEAL-D studies for any surgical procedure/device. Outcomes were extracted verbatim, including contextual information regarding outcome selection and measurement. Outcomes were categorized to inform a conceptual framework of outcome domains relevant to evaluating innovation. Results: Some 48 studies were identified. Outcome selection, measurement and reporting varied widely across studies in different IDEAL stages. From 1737 outcomes extracted, 22 domains specific to evaluating innovation were conceptualized under seven broad categories: procedure completion success/failure; modifications; unanticipated events; surgeons' experiences; patients' experiences; resource use specific to the innovative procedure/device; and other innovation-specific outcomes. Most innovation-specific outcomes were measured and reported in only a small number of studies. Conclusion: This review highlighted the need for guidance and standardization in outcome selection and reporting in the evaluation of new surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations.

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Laparoscopic pancreatoduodenectomy combined with a novel self-assessment system and feedback discussion: a phase 1 surgical trial following the IDEAL guidelines

Abstract: Our triad system for evaluating Lap-PD could be a useful tool for the safe introduction and maintenance of Lap-PD.

Cited by 6 publications

References 37 publications

Minimally invasive versus open pancreatoduodenectomy—systematic review and meta-analysis

Minimally invasive versus open pancreatoduodenectomy—systematic review and meta-analysis

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

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