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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43568

Enrollment

740

Registered

2015-08-11

Start date

2015-06-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastro-intestinal cancer and obesity

Interventions

Intra-operative intravenous injection of indocyanine green that can be visualized with a near-infrared camera to assess the blood perfusion of the organ. In case of a less perfused initial anastomos

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The feasibility and utility of indocyanine green fluorescence imaging for intraoperative perfusion assessment in patients undergoing gastro-intestinal surgery, primarily measured by the number of intraoperative changes in the level of anastomosis.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)