Intraoperative use of fluorescence with indocyanine green reduces anastomotic leak rates in rectal cancer surgery: an in
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and Other Interventional Techniques
REVIEW ARTICLE
Intraoperative use of fluorescence with indocyanine green reduces anastomotic leak rates in rectal cancer surgery: an individual participant data analysis Alberto Arezzo1 · Marco Augusto Bonino2 · Frédéric Ris2 · Luigi Boni3 · Elisa Cassinotti3 · Dominic Chi Chung Foo4 · Nga Fan Shum4 · Alberto Brolese5 · Francesco Ciarleglio5 · Deborah S. Keller6 · Riccardo Rosati7 · Paola De Nardi7 · Ugo Elmore7 · Uberto Fumagalli Romario8 · Mehraneh Dorna Jafari9 · Alessio Pigazzi9 · Evgeny Rybakov10 · Mikhail Alekseev10 · Jun Watanabe11 · Nereo Vettoretto12 · Roberto Cirocchi13 · Roberto Passera14 · Edoardo Forcignanò1 · Mario Morino1 Received: 9 April 2020 / Accepted: 9 June 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Background Fluorescence imaging by means of Indocyanine green (ICG) has been applied to intraoperatively determine the perfusion of the anastomosis. The purpose of this Individual Participant Database meta-analysis was to assess the effectiveness in decreasing the incidence of anastomotic leak (AL) after rectal cancer surgery. Methods We searched PubMed, Embase, Cochrane Library and ClinicalTrial.gov, EU Clinical Trials and ISRCTN registries on September 1st, 2019. We considered eligible those studies comparing the assessment of anastomotic perfusion during rectal cancer surgery by intraoperative use of ICG fluorescence compared with standard practice. We defined as primary outcome the incidence of AL at 30 days after surgery. The studies were assessed for quality by means of the ROBINS-I and the Cochrane risk tools. We calculated odds ratios (ORs) using the Individual patient data analysis, restricted to rectal lesions, according to original treatment allocation. Results The review of the literature and international registries produced 15 published studies and 5 ongoing trials, for 9 of which the authors accepted to share individual participant data. 314 patients from two randomized trials, 452 from three prospective series and 564 from 4 non-randomized studies were included. Fluorescence imaging significantly reduced the incidence of AL (OR 0.341; 95% CI 0.220–0.530; p 65 years, body mass index (BMI) ≥ 25 kg/m2, tumour distance ≤ 6 cm from anal verge, anastomotic distance ≤ 6 cm from anal verge and preoperative radiotherapy (RT) and/or chemotherapy (CT). We also collected data for preoperative characteristics of patients such as cardiovascular diseases, steroid therapy, tobacco use and intraoperative characteristics of patients such as operative time, type of anastomosis, protective stoma, pT, pN, pM and stage, in order to verify symmetry.
Quality assessment All studies fulfilling the selection criteria for this review were assessed for methodological quality and risk of bias. Table 1 shows individual scores of quality assessment items per study, assessed using ROBINS-I tool [18] and Cochrane
risk tool [19]. As most of the series included data of colonic and rectal lesions in a way that could not be distinguish
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