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This is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.
The design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. After surgery on 7-8 POD patients are examined to two sides X-Ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a Foley catheter for diagnosis of anastomotic leakage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG group | Experimental | A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice with the addition of intraoperative imaging using fluorescence angiography with indocianyne green to assess colon and rectal tissue perfusion. |
|
| Standard | No Intervention | A sigmoid and rectum resection with colorectal anastomosis will be performed according to the surgeons standard practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence angiography with indocianyne green | Device | The fluorescence angiography was performed after mobilization of the bowel, transection of the rectum, division of the rectal and colon mesentery and central vessels, before specimen extraction or resection and creation of the anastomosis. This site was selected by the surgeon using his or her best judgment and typical standard of care assessment. After this selection, the anesthesiologist administered a bolus of 1 to 2 ml indocianyne green intravenously. Perfusion of the colon was visualized and assessed via fluorescence angiography and the line of demarcation between perfused and nonperfused tissue was noted and compared with the initial planned transection point. |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic Leak Rate | 0 to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
18 years and older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Scientific Centre of Coloproctology | Moscow | 123423 | Russia |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D012811 | Sigmoid Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D005451 | Fluorescein Angiography |
| ID | Term |
|---|---|
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003110 | Colonic Neoplasms |
| D003108 | Colonic Diseases |
| D012810 | Sigmoid Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003941 | Diagnostic Techniques, Ophthalmological |