Validation of ICG to Identify the Urethra During Rectal Surgery

Phase 2TerminatedNCT03204201

Oxford University Hospitals NHS Trust5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Urethra Injury Rectal Cancer Surgery

Interventions

Indocyanine Green SolutionDRUG

Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Outcomes

Primary Outcomes

Number of urethras identified under white light and fluorescence

Time frame: 1 day

Secondary Outcomes

Signal to background ratios between cohorts of patients with varying doses of ICG

Time frame: 1 day

Subjective assessment of usefulness of technology during operative procedure

Time frame: 1 day

Length of time of interruption in operative procedure to perform trial intervention

Time frame: 1 day

Number of adverse events related to trial intervention

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.