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Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.
An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results.
Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The ICG group | Active Comparator | The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green. |
|
| The control group | Placebo Comparator | The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG-guided bowel perfusion assessment | Drug | ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-days Anastomotic Leakage (AL) rate | Anastomotic leakage rate | 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate | 30-days | |
| mortality | 30-days | |
| days in hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vadim Kuznetsov | Contact | +79043302184 | vad33671477@yandex.ru | |
| Timur Lankov | Contact | +79046077444 | dr@timlankov.ru |
| Name | Affiliation | Role |
|---|---|---|
| Victor Kashchenko, Doctor of Medical Sciences | BELOOSTROV Clinic of High Technologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BELOOSTROV Clinic of High Technologies | Vsevolozhsk District | Leningradskaya Oblast' | 188640 | Russia |
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multicentre randomized controlled trial
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Intraoperative imaging cannot blind the surgeon. The patient is only blinded prior to surgery.
| Conventional Bowel Anastomosis group | Other | conventional perfusion assessment |
|
| 90-days |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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