Indocyanine green fluorescence angiography for anastomotic perfusion assessment in colorectal surgery: a systematic review with meta-analysis, meta-regression, and trial sequential analyses.

Indocyanine green fluorescence angiography (ICGFA) is an adjunctive digital method of assessing bowel perfusion intraoperatively.

吲哚菁绿荧光血管造影（ICGFA）是一种辅助的数字方法，用于术中评估肠道灌注。

We assessed whether ICGFA use during surgery reduces postoperative anastomotic leak exclusively using data from randomised controlled trials (RCTs).

我们评估了在手术中使用ICGFA是否能专门减少术后吻合口漏，仅使用随机对照试验（RCTs）的数据。

Methods

In this systematic reviewand meta-analysis, we searched PubMed, ScienceDirect, Scopus, Web of Science, Embase, and the Cochrane Collaboration databases from inception to July 19, 2025, for English-language RCTs comparing additive intraoperative ICGFA with standard surgeon perfusion assessment alone in patients undergoing colorectal resection with primary anastomosis according to prespecified criteria and PRISMA guidelines.

在这项系统评价和荟萃分析中，我们按照预先设定的标准和PRISMA指南，从建库到2025年7月19日，对PubMed、ScienceDirect、Scopus、Web of Science、Embase和Cochrane协作数据库进行了检索，以寻找比较添加性术中ICGFA与仅使用标准外科医生灌注评估的英语RCTs，这些RCTs涉及接受结直肠切除术并进行原位吻合的患者。

Summary-level data were extracted by two reviewers.

两位评审员提取了摘要层面的数据。

The primary outcome was overall anastomotic leak rate.

主要结果指标是总体吻合口漏率。

The Jadad scale (Oxford quality scoring system) was used to assess trial quality, the Cochrane Risk of Bias (RoB 2) tool for RCTs was used to assess risk of bias, and GRADE was used to assess strength of evidence.

使用了Jadad量表（牛津质量评分系统）来评估试验质量，使用了Cochrane偏倚风险（RoB 2）工具来评估随机对照试验的偏倚风险，并使用了GRADE来评估证据的强度。

Meta-regression and trial sequential analyses were performed.

进行了元回归分析和试验序贯分析。

This study is registered with PROSPERO, CRD420250652639.

本研究已在PROSPERO注册，注册号为CRD420250652639。

Results

719 records were initially identified, with 387 remaining after screening and 184 sought for full eligibility screening, of which nine were eligible RCTs (with 4754 patients) for analysis.

最初确定了719条记录，经过筛选后剩余387条，进一步对184条记录进行了全面资格审查，最终有九项符合条件的随机对照试验（共4754名患者）纳入分析。

ICGFA significantly reduced overall anastomotic leak (risk ratio 0·66 [95% CI 0·56-0·78], p<0·0001; number needed to treat [NNT]=24), with trial sequential analysis showing that the required information size (2183) was exceeded overall.

ICGFA显著降低了总体吻合口漏的发生率（风险比0·66 [95% 置信区间 0·56-0·78]，p<0·0001；需要治疗的患者数[NNT]=24），试验序贯分析显示所需信息量（2183）总体上已超过。

ICGFA reduced both anastomotic leak requiring intervention (risk ratio 0·73 [95% CI 0·60-0·89], p=0·0020; NNT=39) and anastomotic leak not requiring intervention (0·48 [0·31-0·72], p=0·0004, NNT=35).

ICGFA减少了需要干预的吻合口漏（风险比0·73 [95% 置信区间 0·60-0·89]，p=0·0020；NNT=39）以及不需要干预的吻合口漏（0·48 [0·31-0·72]，p=0·0004，NNT=35）。

Significant benefit was observed for left-sided resections (risk ratio 0·62 [95% CI 0·51-0·74], p<0·0001; NNT=19), rectal resections (0·62 [0·51-0·76], p<0·0001; NNT=19), and low anterior resections (0·62 [0·48-0·79], p<0·0001; NNT=13), in which the required information size was also exceeded, but not for right-sided resections.

对于左侧切除术，观察到显著的益处（风险比为0.62 [95% 置信区间 0.51-0.74]，p<0.0001；NNT=19），直肠切除术（0.62 [0.51-0.76]，p<0.0001；NNT=19）和低位前切除术（0.62 [0.48-0.79]，p<0.0001；NNT=13），在这些手术中，所需的信息量也已超过，但并未对右侧切除术产生显著益处。

In the meta-regression analysis, among all tested covariates, only patient BMI significantly modified the ICGFA treatment effect, with an increasing protective effect with increasing BMI (coefficient -0·0153 [95% CI -0·0251 to -0·0056], p=0·0020).

在元回归分析中，所有测试的协变量中，只有患者的体重指数（BMI）显著改变了ICGFA治疗效果，随着BMI的增加，保护效果也增加（系数-0.0153 [95% 置信区间 -0.0251 到 -0.0056]，p=0.0020）。

Evidence was graded as high certainty for overall, left-sided, rectal, asymptomatic, and 30-day anastomotic leaks, and moderate certainty for clinically significant anastomotic leak.

证据被评定为总生存、左半结肠、直肠、无症状和30天吻合口漏的高确定性，以及临床显著吻合口漏的中等确定性。

interpretation

Intraoperative use of ICGFA reduces anastomotic leak rates in left-sided and rectal colorectal resections.

术中使用ICGFA可以降低左半结肠和直肠结直肠切除术的吻合口漏率。

Given the evidence available now, further general efficacy trials are no longer required and research should shift to implementation and defined targeted subgroup ICGFA role definition (ie, in non-rectal left-sided resections).

鉴于目前可用的证据，不再需要进一步的通用有效性试验，研究应转向实施和定义特定目标亚组ICGFA角色定义（例如，在非直肠左侧切除术中）。

funding

None.

无。