Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medical Center Haaglanden | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Haga Hospital | OTHER |
| Jeroen Bosch Ziekenhuis |
Not provided
Not provided
Not provided
Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image Guided Bowel Anastomosis group | Experimental | ICG-guided perfusion assessment |
|
| Conventional Bowel Anastomosis group | No Intervention | conventional perfusion assessment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG-guided bowel perfusion assessment | Drug | ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90-days Anastomotic Leakage (AL) rate | Anastomotic leakage rate | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 30-days Anastomotic Leakage ( AL) rate | Anastomotic leakage rate | 30 days |
| complication rate | 90 days | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Vahrmeijer, MD, PhD | Contact | 071 526 9111 | a.l.vahrmeijer@lumc.nl | |
| Ruben Meijer, MD | Contact | 071 526 9111 | r.p.j.meijer@lumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Vahrmeijer, MD, PhD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | South Holland | 2333 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39151436 | Derived | Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13. | |
| 35365509 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| OTHER |
| Amphia Hospital | OTHER |
| Alrijne Hospital | OTHER |
| IJsselland Hospital | OTHER |
National randomized controlled trial.
Not provided
Not provided
Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.
| mortality |
| 90 days |
| days in hospital stay | 90 days |
| Derived |
| Meijer RPJ, Faber RA, Bijlstra OD, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Mieog JSD, Burggraaf K, Vahrmeijer AL, Hilling DE; AVOID study group. AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery. BMJ Open. 2022 Apr 1;12(4):e051144. doi: 10.1136/bmjopen-2021-051144. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |