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| Name | Class |
|---|---|
| Perfusion Tech Aps | UNKNOWN |
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Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.
While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).
The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.
This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal cancer patients | Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative Indocyanine Green Fluorescence Angiography | Other | Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative anastomotic complications | combined rate of all anastomotic complications | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with complications according to Clavien-Dindo Classification | 90 days | |
| Number of participants with anastomotic leakage rate, severity (grade A-C) | 90 days | |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include 115 participants undergoing elective resection with PME or TME for rectal or rectosigmoid cancer through a minimally invasive approach.
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| Name | Affiliation | Role |
|---|---|---|
| Ismail Gögenur, DMSc, MD | Department of Surgery, Zealand University Hospital | Principal Investigator |
| Niclas Dohrn, MD | Department of Surgery, Herlev Hospital | Principal Investigator |
| Mads Falk Klein, PhD, MD | Department of Surgery, Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Zealand University Hospital | Køge | Region Sjælland | 4200 | Denmark | ||
| Department of Surgery, Herlev Hospital |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D057868 | Anastomotic Leak |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Number of participants with postoperative bleeding |
| 10 days |
| Number of participants with postoperative paralytic ileus | obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal surgery | 90 days |
| Number of participants with wound dehiscence | surgical complication in which a wound ruptures along a surgical incision | 1 month |
| Comprehensive complications index | 90 days |
| Duration of surgery | 1 day |
| Reoperation rate | 1 month |
| Hospital readmission | Number of patients had have to be readmitted to the hospital due to postoperative complications | 1 month |
| Length of hospital stay | 1 month |
| QT interval variability | Continuous ECG-monitoring intraoperatively and postoperatively | 2 days |
| Herlev |
| 2730 |
| Denmark |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |