Validation of ICG to Identify the Urethra During Rectal Surgery

NHS Trust

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Surgery; Rectal Cancer; Urethra Injury

Treatments: Drug: Indocyanine Green Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03204201

12748

Details and patient eligibility

About

This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.

Enrollment: 5 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is willing and able to give informed consent for participation in the study.
• Male, aged 18 years or above.
• Undergoing low rectal surgery where the operating field will be close to the urethra

Exclusion criteria

• Participant has an allergy to iodine or ICG
• Known liver failure

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Urethral instillation of ICG

Experimental group

Description:

Urethral instillation of indocyanine green (ICG)

Treatment:

Drug: Indocyanine Green Solution