Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

978 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Colo-rectal Cancer Crohn Disease Resectable Colorectal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

National randomized controlled trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.

Study Groups

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Image Guided Bowel Anastomosis group

ICG-guided perfusion assessment

Group Type EXPERIMENTAL

ICG-guided bowel perfusion assessment

Intervention Type DRUG

ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

Conventional Bowel Anastomosis group

conventional perfusion assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ICG-guided bowel perfusion assessment

ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
2. Patients aged over 18 years old;
3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
4. Signed informed consent prior to any study-mandated procedure;

Exclusion Criteria

1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
2. Severe liver or kidney insufficiency;
3. Hyperthyroidism or a benign thyroid tumour;
4. Pregnant or breastfeeding women;
5. Scheduled for palliative surgery or terminal ill
6. Scheduled for a diverting stoma
7. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;
8. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
9. Emergency surgery

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No