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A randomized controlled multicenter trial on the usefulness of intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic rectal resection or left colectomy.
Anastomotic leakage after colorectal surgery is a severe complication. One possible cause of anastomotic leakage is insufficient vascular supply. The aim of this study is to evaluate the usefulness of intraoperative assessment of vascular anastomotic perfusion in laparoscopic colorectal surgery using indocyanine green (ICG)-enhanced fluorescence, in order to assess if the information of the ICG angiography could lead to change the site of resection and improving the anastomotic leak rate. Two-hundred and eight patients, undergoing rectal resection or left colectomy, for benign or malignant disease, with high vessels ligation, will be randomized intro 2 arms: ICH angiography (colonic perfusion is intraoperatively assed with ICG angiography and level of resection is selected based on the fluorescence) and Control (resection is performed with subjective judgment). The rate of postoperative leak in the two groups will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG- angiography | Experimental | Colonic resection margins and colo-rectal anastomosis are intraoperatively assessed using fluorescence angiography to evaluate colonic perfusion. If perfusion at the resection margin is judged "insufficient" the colon is re-resected to obtain a satisfactory perfusion |
|
| No angiography | Active Comparator | Subjective measures are employed to determine anastomotic perfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG- angiography | Procedure | Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic leak rate | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paola De Nardi, MD | San Raffaele Scientific Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Scientific Institute | Milan | 20129 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30903276 | Derived | De Nardi P, Elmore U, Maggi G, Maggiore R, Boni L, Cassinotti E, Fumagalli U, Gardani M, De Pascale S, Parise P, Vignali A, Rosati R. Intraoperative angiography with indocyanine green to assess anastomosis perfusion in patients undergoing laparoscopic colorectal resection: results of a multicenter randomized controlled trial. Surg Endosc. 2020 Jan;34(1):53-60. doi: 10.1007/s00464-019-06730-0. Epub 2019 Mar 21. |
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| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D012810 | Sigmoid Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
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| No angiography | Procedure | Extension of resection based on subjective measures |
|