Dataset Information

Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leakage in Patients Undergoing Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials and Propensity-Score-Matched Studies.

ABSTRACT:

Background

Meta-analyses have demonstrated that indocyanine green (ICG) can effectively prevent anastomotic leakage (AL) after colorectal surgery. However, recent evidence from large randomized controlled trial (RCT) has suggested that ICG fluorescence angiography does not reduce the incidence of AL in colorectal surgery. This study was conducted to evaluate the value of ICG for the prevention of AL following colorectal surgery.

Methods

Up to September 16, 2021, PubMed, Embase, China National Knowledge Infrastructure, Web of Science, Scopus, Cochrane Library, and VIP databases were searched for RCTs and propensity-score matched (PSM) studies evaluating the use of ICG for prevention of AL after colorectal surgery. Mean differences (MDs) or odds ratios (ORs) and 95% confidence intervals (CI) were calculated.

Results

Twenty studies (5 RCTs and 15 PSM studies) with a total of 5,125 patients were included. ICG did not reduce the reoperation rate (OR, 0.71; 95% CI, 0.38, 1.30), conversion rates (OR, 1.34; 95% CI, 0.65, 2.78), or mortality (OR, 0.50; 95% CI, 0.13, 1.85), but ICG did reduce the incidence of AL (OR, 0.46; 95% CI, 0.36, 0.59) and symptomatic AL (OR, 0.48; 95% CI, 0.33, 0.71), and reduced the length of hospital stay (MD,-1.21; 95% CI,-2.06,-0.35) and intraoperative blood loss (MD,-9.13; 95% CI,-17.52,-0.74). In addition, ICG use did not increase the incidence of total postoperative complications (OR, 0.93; 95% CI, 0.64, 1.35), postoperative ileus (OR, 1.26; 95% CI, 0.53, 2.97), wound infection (OR, 0.76; 95% CI, 0.44, 1.32), urinary tract infection (OR, 0.87; 95% CI, 0.30, 2.59), pulmonary infection (OR, 0.23; 95% CI, 0.04, 1.45), urinary retention (OR, 1.08; 95% CI, 0.23, 5.04), anastomotic bleeding (OR, 1.53; 95% CI, 0.27, 8.60), anastomotic stricture (OR, 0.74; 95% CI, 0.24, 2.29), or operative time (MD,-9.64; 95% CI,-20.28, 1.01).

Conclusions

ICG can effectively reduce the incidence of AL, without prolonging the operation time or increasing postoperative complications in colorectal surgery.

Systematic review registration

www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42021279064.

SUBMITTER: Tang G

PROVIDER: S-EPMC8964518 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leakage in Patients Undergoing Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials and Propensity-Score-Matched Studies.

Tang Gang G Du Donglin D Tao Jie J Wei Zhengqiang Z

Frontiers in surgery 20220315

<h4>Background</h4>Meta-analyses have demonstrated that indocyanine green (ICG) can effectively prevent anastomotic leakage (AL) after colorectal surgery. However, recent evidence from large randomized controlled trial (RCT) has suggested that ICG fluorescence angiography does not reduce the incidence of AL in colorectal surgery. This study was conducted to evaluate the value of ICG for the prevention of AL following colorectal surgery.<h4>Methods</h4>Up to September 16, 2021, PubMed, Embase, Ch ...[more]

PMID: 35372484

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Project description:Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer in the world and the third in France. Its incidence is steadily rising in developing nations. Anastomotic leak (AL) is a major problem in colorectal surgery affecting at least 7% of patients operated on for left colonic cancer. It is the most feared complication after colorectal anastomosis, associated with mortality, prolonged hospitalization, impaired health related quality of life (HRQoL) and increased health care costs. Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG) may help preventing AL. Available studies on the effects of IOFA with ICG are heterogeneous and randomized controlled trial are scarce. Our aim is to demonstrate that IOFA with ICG could lead to a reduction of AL rate after left-sided or low anterior resection with anastomosis for CRC. The FLUOCOL-1 study is the first national, multicenter, single blind, randomized, 2-arm, phase III superiority clinical trial. The primary endpoint is the occurrence of an AL 90 days post-operation. AL is defined as any anastomotic dehiscence with leakage into the pelvic cavity diagnosed upon imaging or at surgical exploration or any isolated pelvic organ-space infection with no evidence of fistula as defined by the International Study Group of Rectal Cancer. The study population will be made of adult patients with left-sided or high rectal cancer scheduled to undergo elective left colectomy or high rectal resection (by open, laparoscopy or robotic surgery) and with expected stapled or hand-sewn intraperitoneal anastomosis. The exclusion criteria are mainly an emergent surgery; rectal cancer requiring total mesorectal excision and anastomosis expected below the peritoneal reflection; CRC requiring total or subtotal colectomy; CRC requiring transverse colectomy; recurrent CRC and locally advanced colorectal cancer requiring multi-visceral excision. A total of 1010 patients will be necessary (39 patients in each centre during 36 months). An interim analysis for efficacy and futility is scheduled when half of the participants will have been recruited. In case of positive results favoring IOFA, this study would define the use of IOFA as a standard of care in colorectal surgery. At the patient level, a significantly lower rate of AL will reduce hospital stay and stoma rate, and will ensure improved postoperative recovery, faster return to normal activity and better long-term oncologic outcomes.

Project description:ImportancePerforming a bowel anastomosis is a critical step in colorectal resection. Assessing the risk of anastomotic leakage remains challenging, even for experienced surgeons.ObjectiveTo evaluate the use of indocyanine green (ICG) fluorescence imaging in assessing perfusion at the anastomotic site before and after anastomosis and determine whether it helps reduce anastomotic leakages.Design, setting, and participantsICG-COLORAL is a prospective, randomized, multicenter study conducted from September 1, 2018, to December 31, 2023. Participants were recruited during preoperative outpatient clinic visits by clinicians not involved in the study, as well as by researchers. Participants were elective patients scheduled for laparoscopic resections, excluding low anterior resections, with planned primary anastomosis in 5 Finnish public hospitals experienced in laparoscopic colorectal surgery.InterventionThe intervention group received 5 mg of ICG intravenously before and after anastomosis formation. The fluorescence signal was assessed with a near-infrared-capable camera. The control group did not receive ICG fluorescence imaging.Main outcome and measureThe primary outcome measure was the anastomotic leak rate as detected by computed tomography.ResultsAmong 1136 patients in the intention-to-treat population, 526 (46.3%) were female and 610 (53.7%) male; they had a mean (SD) age of 70 (11) years, body mass index of 28 (5), and age-adjusted Charlson Comorbidity Index of 5 (3). Overall, the anastomotic leak rate was 5.8% (33/567) in the ICG fluorescence imaging group vs 7.9% (45/569) in the control group (odds ratio [OR], 0.73; 95% CI, 0.48-1.13; P = .16). For right-sided operations, the anastomotic leak rate with ICG fluorescence imaging was 5.9% (16/273) vs 6.7% (20/298) in the control group (OR, 0.87; 95% CI, 0.46-1.65). For left-sided operations, the anastomotic leak rate was 5.2% (14/267) with ICG fluorescence imaging vs 9.5% (23/243) without (OR, 0.55; 95% CI, 0.29-1.05). No patients reported adverse events related to ICG.Conclusions and relevanceThis study found that routine use of ICG fluorescence imaging does not significantly reduce the overall anastomotic leak rate in laparoscopic colorectal surgery if low anterior resections are excluded but may be beneficial in left-sided operations.Trial registrationClinicalTrials.gov Identifier: NCT03602677.

Project description:Background and objectiveQuantitative studies of indocyanine green (ICG) are needed to optimize its evaluative potential in anastomotic perfusion during colorectal surgery. However, some limitations still existed in current studies about qualitative evaluations such as small-scale studies, the inconsistent concentration of the drug, the method of injection, etc. Therefore, this review summarized the primary quantitative parameters, image, method, and so on, during ICG fluorescence angiography aiming to further provide a theoretical basis for the application of ICG in laparoscopic colorectal surgery.MethodsThe following keywords "indocyanine green or ICG", "anastomotic perfusion", and "colorectal surgery" were applied to search for literature published from 2002 to 2022 in the PubMed, Web of Science, and Medline databases. Then, the information about ICG fluorescence angiography in quantitative evaluation of anastomotic perfusion during colorectal surgery was summarized. Through integrating the experiences derived from the literature and our research center, the crucial quantitative parameters [such as T0, Tmax, Fmax, and S (Fmax/Tmax)], image characteristics, and standard operational process for ICG fluorescence angiography were summarized.Key content and findingsFirstly, quantitative parameters, including T0, Tmax, Fmax, and S (Fmax/Tmax) during the ICG fluorescence angiography could predict anastomotic leakage, and thus should be recorded. Secondly, the image curve generated by the software might differ among patients, which included a filling period, reducing period, and platform period; some patients even presented a second fluorescence intensity peak. Finally, present studies presented great heterogeneity regarding the injection dose of ICG, observation distance from the laparoscope to the anastomotic site, software, and so on, during ICG fluorescence angiography in quantitatively evaluating the intestinal blood perfusion.ConclusionsThis review points out the challenges of ICG fluorescence angiography in quantitative evaluation of anastomotic perfusion and gives some advice. However, some difficulties and issues are non-neglectable during the clinical implications of the quantitative evaluation of ICG, such as standardizing the specific cut-off value about the quantitative parameters, injection dose of ICG, observation distance from the laparoscope to the anastomotic site, software, and so on, during ICG fluorescence angiography in quantitatively evaluating the intestinal blood perfusion to eliminate heterogeneity.

Project description:BackgroundIndocyanine green fluorescence angiography (ICGFA) during colorectal surgery either reassures surgeons regarding intestinal perfusion sufficiency or prompts changed surgical strategy by indicating unsuspected insufficiency. This study describes existing evidence supporting ICGFA use in colorectal surgery, particularly regarding impact on intraoperative decisions.MethodsSearches were performed on PubMed, ScienceDirect, Scopus, Web of Science, Cochrane Collaboration databases on 5th December 2023, updated to 19th August 2024. Full English language publications of clinical studies in human patients undergoing colorectal resection with primary anastomosis with the use of ICGFA to assess bowel perfusion intraoperatively, with a control group, were included. Pooling of anastomotic leak (AL) rates was performed for primary outcome analysis with odds ratio (OR) and number-needed-to-treat (NNT) calculated regarding leak reduction.Results45 studies comprising 14,333 patients were included, with 7 randomised controlled trials (2911 patients). Overall, AL rate was 6.8%, 4.5% with ICGFA and 8.5% without (OR:0.47, p < 0.001, NNT 23), increasing to 9.5%, 7.5% and 11.6%, respectively, in randomised controlled trials (OR:0.62, p < 0.01, NNT 25). In rectal resections, AL rate was 4.7% with ICGFA vs 11.5% without (OR: 0.38, p < 0.0001). 26 studies performed ICGFA before and after anastomosis formation and 19 used ICGFA only prior to bowel transection, with no significant difference of AL rate reduction on subgroup testing. ICGFA prompted a change in surgical plan in 8.4% of thirty-four studies reporting this. Interestingly, in these studies, leak rates overall were 3.7% when ICGFA matched surgeon judgement versus 5.7% when it prompted change (OR 0.51, p < 0.0025), versus 7.7% without (OR 0.45, p < 0.0001). In rectal resections, these figures were 5%, 8.8% (OR 0.42, p = 0.01) and 12.0% (OR0.39, p < 0.0001), respectively.ConclusionsICGFA colorectal perfusion assessment is associated with lower anastomotic leak rates, especially when confirming surgeons' judgement, and may so stratify patients post-operatively regarding subsequent anastomotic leak rate.

Dataset Information

Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leakage in Patients Undergoing Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials and Propensity-Score-Matched Studies.

Background

Methods

Results

Conclusions

Systematic review registration

Publications

Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leakage in Patients Undergoing Colorectal Surgery: A Meta-Analysis of Randomized Controlled Trials and Propensity-Score-Matched Studies.

Similar Datasets

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