Validation of ICG to Identify the Urethra During Rectal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2018-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Urethra Injury Rectal Cancer Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Urethral instillation of ICG

Urethral instillation of indocyanine green (ICG)

Group Type EXPERIMENTAL

Indocyanine Green Solution

Intervention Type DRUG

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

Interventions

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Indocyanine Green Solution

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

Intervention Type DRUG

Eligibility Criteria

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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