Quality of reporting of robot-assisted cholecystectomy in relation to the IDEAL recommendations: systematic review

Author:

Kirkham Emily N12,Jones Conor S13,Higginbotham George3,Biggs Sarah4,Dewi Ffion4,Dixon Lauren14,Huttman Marc15,Main Barry G1467,Ramirez Jozel14,Robertson Harry18,Scroggie Darren L14,Zucker Benjamin14,Blazeby Jane M17ORCID,Blencowe Natalie S147,Pathak Samir9,Vallance A,Wilkinson A,Smith A,Torkington A,Jones A,Abbas A,Main B G,Zucker B,Turner B,Jones C S,Thomas C,Hoffmann C,Scroggie D L,Henshall D,Kirkham E N,Boden E,Gull E,Sewart E,Dewi F,Wood F,Loro F,Hollowood F,Fowler G,Higginbotham G,Sellers G,Robertson H,Richards H,Hughes I,Handa I,Blazeby J M,Olivier J,Ramirez J,Rees J,Chalmers K,Lee K Siang,Dixon L,Leandro L,Paynter L,Huppler L,Gourbault L,Huttman M,Wijeyaratne M,Dewhurst M,Shah M,Kiandee M,Dada M,Blencowe N S,Brewster O,Lok P,Winayak R,Ranat R,Macefield R,Purves R,Lawrence R,Millar R,Biggs S,Lawday S,Dalmia S,Cousins S,Pathak S,Rozwadowski S,Robinson T,Perra T,Leow T Wei,Brankin-Frisby T,Baker W,Hurst W,Young Y Embury,

Affiliation:

1. Bristol Centre for Surgical Research, Population Health Sciences, University of Bristol , Bristol , UK

2. Musgrove Park Hospital , Taunton , UK

3. North Bristol NHS Foundation Trust , Bristol , UK

4. University Hospitals Bristol and Weston NHS Foundation Trust , Bristol , UK

5. University College Hospital, University College London Hospitals NHS Foundation Trust , London , UK

6. Bristol Dental School, University of Bristol , Bristol , UK

7. NIHR Bristol Biomedical research centre , Bristol , UK

8. Imperial College Healthcare NHS Trust , London

9. St James’s University Hospital, Leeds Teaching Hospitals NHS Trust , Leeds , UK

Abstract

Abstract Introduction Robotic cholecystectomy (RC) is a recent innovation in minimally invasive gallbladder surgery. The IDEAL (idea, development, exploration, assessment, long-term study) framework aims to provide a safe method for evaluating innovative procedures. This study aimed to understand how RC was introduced, in accordance with IDEAL guidelines. Methods Systematic searches were used to identify studies reporting RC. Eligible studies were classified according to IDEAL stage and data were collected on general study characteristics, patient selection, governance procedures, surgeon/centre expertise, and outcome reporting. Results Of 1425 abstracts screened, 90 studies were included (5 case reports, 38 case series, 44 non-randomized comparative studies, and 3 randomized clinical trials). Sixty-four were single-centre and 15 were prospective. No authors described their work in the context of IDEAL. One study was classified as IDEAL stage 1, 43 as IDEAL 2a, 43 as IDEAL 2b, and three as IDEAL 3. Sixty-four and 51 provided inclusion and exclusion criteria respectively. Ethical approval was reported in 51 and conflicts of interest in 34. Only 21 reported provision of training for surgeons in RC. A total of 864 outcomes were reported; 198 were used in only one study. Only 30 reported a follow-up interval which, in 13, was 1 month or less. Conclusion The IDEAL framework was not followed during the adoption of RC. Few studies were conducted within a research setting, many were retrospective, and outcomes were heterogeneous. There is a need to implement appropriate tools to facilitate the incremental evaluation and reporting of surgical innovation.

Funder

National Institute for Health Research

University Hospitals Bristol and Weston NHS Foundation Trust

Publisher

Oxford University Press (OUP)

Subject

General Medicine

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