A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES

Phase 3

Recruiting

Conditions: Anastomotic leakage
intestinal connection leakage
10017998

Registration Number: NL-OMON52391

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 978

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 and kidney insufficiency;
3. Hyperthyroidism or a benign thyroid tumour;
4. Pregnant or breastfeeding women;
5. Scheduled for palliative surgery or terminal ill
6. 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;
7. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin,
haloperidol, nitrofurantoin, probenecid;
8. Emergency surgery

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the clinically relevant anastomosis leakage rate at 90<br /><br>days. AL will be defined according to the proposal of the International Study<br /><br>Group of Rectal Cancer; as a communication between the intra- and extraluminal<br /><br>compartments owing to a defect in of the integrity of the intestinal wall at<br /><br>the level of the anastomosis. According to our study clinical relevance depends<br /><br>on whether or not treatment is started. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Alteration of surgery<br /><br>2. Difference in 30 day clinically relevant leakage rate<br /><br>3. Difference in overall 30 and 90 day complication rate<br /><br>4. Difference in 30 and 90 day mortality<br /><br>5. Difference in 30 and 90 day reintervention rate<br /><br>6. Difference in surgical time<br /><br>7. Duration of in hospital treatment<br /><br><br /><br>Other study parameters<br /><br>Important baseline criteria will be documented. This includes age, gender,<br /><br>weight, height, BMI, general history, concomitant medication and substance<br /><br>abuse. Surgical information like type of surgery (hemicolectomy left/right,<br /><br>sigmoid resection, low anterior resection etc.), indication (malignancy,<br /><br>inflammatory bowel disease, diverticulitis etc. and distance of anastomosis<br /><br>from anal verge will be collected</p><br>