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The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Intraoperative verdye green iv administration to visualize blood supply to the anastomosis |
|
| Control | No Intervention | No administration of verdye green intraoperatively |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verdye Green | Drug | intraoperative iv application of indocyanic green for visualisation of blood supply to the anastomosis after rectal cancer recection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leak | Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line | Up to two weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postsurgical Ileus | Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery | Up to 10 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St John Grande Hospital | Recruiting | Krakow | Lesser Poland Voivodeship | 31-060 | Poland |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |