The use of Indocyanine green fluorescence with near-infrared imaging to intra-operatively assess tissue perfusion in gastrointestinal surgery.

Phase 4

• Conditions: gastro-intestinal cancer and obesity; 10017991; 10017998

• Registration Number: NL-OMON43568
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 740

Inclusion Criteria

* Patients that undergo elective gastrointestinal surgical resection with primary anastomosis or undergo a Roux-Y gastric bypass/gastric sleeve resection.
* Written informed consent
* Age >18 years

Exclusion Criteria

* Peritoneal metastases found during surgery
* Pre-existent or creation of a diverting colostomy/ileostomy
* Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The feasibility and utility of indocyanine green fluorescence imaging for<br /><br>intraoperative perfusion assessment in patients undergoing gastro-intestinal<br /><br>surgery, primarily measured by the number of intraoperative changes in the<br /><br>level of anastomosis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The effect of intraoperative indocyanine green fluorescence imaging in<br /><br>gastro-intestinal surgery on:<br /><br>- The occurrence of clinical/subclinical anastomotic leakage.<br /><br>- Need for a colostomy.<br /><br>- Adverse reactions on IV indocyanine green admission.<br /><br>- Operation time.<br /><br>- Need for additional surgical, radiological or endoscopic interventions.<br /><br>- Other complications requiring treatment (i.e. urinary tract infection).<br /><br>- Need for ICU admission and total length of ICU stay.<br /><br>- Hospital stay.</p><br>