NCT03177070

Fluorescent Imaging & Methylene Blue: Ureter Study

Investigating the Use of Fluorescent Imaging and Methylene Blue to Identify and Prevent Ureteric Injuries During Laparoscopic and Open Colorectal Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The main aim of this project is to assess whether intravenous methylene blue can help identify the ureters during open and laparoscopic (keyhole) surgery. The ureters are small tubes that link the kidney to the bladder and, if not properly identified during surgery, may be damaged. Methylene blue has been safely given to patients for many years and it is fluorescent. It is removed by the kidney and will therefore travel through the ureters. Methylene blue shines brightly (becomes fluorescent) when viewed under red light. This study aims to compare the ability of methylene blue with white light to identify the location of the ureters during colorectal surgery. Recruitment will include 50 patients undergoing colorectal surgery (25 for keyhole/laparoscopic, 25 for open procedures). Each patient will act as their own control. To detect the fluorescence, a special fluorescent laparoscope for keyhole surgery will be utilised, and a wide-field camera will be used for open surgery. The potential benefits of this procedure are to identify the ureters during surgery and therefore prevent inadvertent damage to them It is hoped that near infra-red light emitting from the ureters will be detected. This will allow the surgeon to determine the anatomy of the ureters during the operation and avoid inadvertent injury. Funding source: Nuffield Department of Surgical Sciences, University of Oxford Recruitment sites: Oxford University Hospitals NHS Trust.

Conditions

• Ureteric Injury
• Surgery
• Surgery--Complications

Interventions

Type	Name	Description
DRUG	Methylene Blue	As described above. Intravenous injection with visualisation via fluorescence enabled laparoscope.

Timeline

• Start date: 2016-05-09
• Primary completion: 2017-05-02
• Completion: 2017-05-02
• First posted: 2017-06-06
• Last updated: 2017-06-06

Locations

1 site across 1 country: United Kingdom