PDF(Pubmed)
Abstract：
BACKGROUND: Anastomotic leakage (AL) is defined as the failure of complete healing or disruption of the anastomosis subsequent to rectal cancer surgery, resulting in the extravasation of intestinal contents into the intra-abdominal or pelvic cavity. It is a serious complication of rectal cancer surgery, accounting for a considerable increase in morbidity and mortality. The use of fluorescence imaging technology in surgery allows surgeons to better evaluate blood perfusion. However, the conclusions of some existing studies are not consistent, so a consensus on whether the near-infrared indocyanine green (NIR-ICG) imaging system can reduce the incidence of AL is needed.
METHODS: This POSTER trial is designed as a multicentre, prospective, randomised controlled clinical study adhering to the \"population, interventions, comparisons, outcomes (PICO)\" principles. It is scheduled to take place from August 2019 to December 2024 across eight esteemed hospitals in China. The target population consists of patients diagnosed with rectal cancer through pathological confirmation, with tumours located≤10 cm from the anal verge, eligible for laparoscopic surgery. Enrolled patients will be randomly assigned to either the intervention group or the control group. The intervention group will receive intravenous injections of ICG twice, with intraoperative assessment of anastomotic blood flow using the near-infrared NIR-ICG system during total mesorectal excision (TME) surgery. Conversely, the control group will undergo conventional TME surgery without the use of the NIR-ICG system. A 30-day follow-up period postoperation will be conducted to monitor and evaluate occurrences of AL. The primary endpoint of this study is the incidence of AL within 30 days postsurgery in both groups. The primary outcome investigators will be blinded to the application of ICG angiography. Based on prior literature, we hypothesise an AL rate of 10.3% in the control group and 3% in the experimental group for this study. With a planned ratio of 2:1 between the number of cases in the experimental and control groups, and an expected 20% lost-to-follow-up rate, the initial estimated sample size for this study is 712, comprising 474 in the experimental group and 238 in the control group.
BACKGROUND: This study has been approved by Ethics committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2019-P2-055-02). The results will be disseminated in major international conferences and peer-reviewed journals.
BACKGROUND: NCT04012645.
METHODS: This POSTER trial is designed as a multicentre, prospective, randomised controlled clinical study adhering to the \"population, interventions, comparisons, outcomes (PICO)\" principles. It is scheduled to take place from August 2019 to December 2024 across eight esteemed hospitals in China. The target population consists of patients diagnosed with rectal cancer through pathological confirmation, with tumours located≤10 cm from the anal verge, eligible for laparoscopic surgery. Enrolled patients will be randomly assigned to either the intervention group or the control group. The intervention group will receive intravenous injections of ICG twice, with intraoperative assessment of anastomotic blood flow using the near-infrared NIR-ICG system during total mesorectal excision (TME) surgery. Conversely, the control group will undergo conventional TME surgery without the use of the NIR-ICG system. A 30-day follow-up period postoperation will be conducted to monitor and evaluate occurrences of AL. The primary endpoint of this study is the incidence of AL within 30 days postsurgery in both groups. The primary outcome investigators will be blinded to the application of ICG angiography. Based on prior literature, we hypothesise an AL rate of 10.3% in the control group and 3% in the experimental group for this study. With a planned ratio of 2:1 between the number of cases in the experimental and control groups, and an expected 20% lost-to-follow-up rate, the initial estimated sample size for this study is 712, comprising 474 in the experimental group and 238 in the control group.
BACKGROUND: This study has been approved by Ethics committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2019-P2-055-02). The results will be disseminated in major international conferences and peer-reviewed journals.
BACKGROUND: NCT04012645.
摘要：
背景：吻合口漏（AL）被定义为直肠癌手术后吻合口完全愈合或破裂的失败，导致肠内容物渗入腹腔或盆腔。它是直肠癌手术的严重并发症，导致发病率和死亡率大幅增加。在外科手术中使用荧光成像技术可以使外科医生更好地评估血液灌注。然而,一些现有研究的结论并不一致，因此，需要就近红外吲哚菁绿（NIR-ICG）成像系统是否可以降低AL的发生率达成共识。
方法：本POSTER试验设计为多中心，prospective,坚持“人群”的随机对照临床研究，干预措施，比较,结果(PICO)“原则。计划于2019年8月至2024年12月在中国八家受人尊敬的医院举行。目标人群包括通过病理证实诊断为直肠癌的患者，肿瘤距离肛门边缘≤10厘米，有资格进行腹腔镜手术。登记的患者将被随机分配到干预组或对照组。干预组将接受两次ICG静脉注射，在全直肠系膜切除术（TME）术中使用近红外NIR-ICG系统评估吻合口血流。相反，对照组将在不使用NIR-ICG系统的情况下接受常规TME手术.术后将进行30天的随访以监测和评估AL的发生。这项研究的主要终点是两组术后30天内AL的发生率。主要结果研究者将对ICG血管造影的应用视而不见。基于先前的文献，在本研究中,我们假设对照组的AL率为10.3%,实验组的AL率为3%.实验组和对照组的病例数之间的计划比例为2：1，以及预期的20%的失访率，本研究的初始估计样本量为712个,其中实验组为474个,对照组为238个.
背景：本研究已获得北京友谊医院伦理委员会的批准，首都医科大学（批准号：2019-P2-055-02）。结果将在主要国际会议和同行评审期刊上传播。
背景：NCT04012645。
方法：本POSTER试验设计为多中心，prospective,坚持“人群”的随机对照临床研究，干预措施，比较,结果(PICO)“原则。计划于2019年8月至2024年12月在中国八家受人尊敬的医院举行。目标人群包括通过病理证实诊断为直肠癌的患者，肿瘤距离肛门边缘≤10厘米，有资格进行腹腔镜手术。登记的患者将被随机分配到干预组或对照组。干预组将接受两次ICG静脉注射，在全直肠系膜切除术（TME）术中使用近红外NIR-ICG系统评估吻合口血流。相反，对照组将在不使用NIR-ICG系统的情况下接受常规TME手术.术后将进行30天的随访以监测和评估AL的发生。这项研究的主要终点是两组术后30天内AL的发生率。主要结果研究者将对ICG血管造影的应用视而不见。基于先前的文献，在本研究中,我们假设对照组的AL率为10.3%,实验组的AL率为3%.实验组和对照组的病例数之间的计划比例为2：1，以及预期的20%的失访率，本研究的初始估计样本量为712个,其中实验组为474个,对照组为238个.
背景：本研究已获得北京友谊医院伦理委员会的批准，首都医科大学（批准号：2019-P2-055-02）。结果将在主要国际会议和同行评审期刊上传播。
背景：NCT04012645。
