BRIGHT

Bleeding Reduction in Grade II-III Haemorrhoids through Embolisation Treatment

Status: in design

Study summary | Objective and outcome measures | Steering Committee

Study summary

BRIGHT is a Europe-wide, prospective, observational cohort study with the aim to collect real-world data on the treatment of bleeding grade II-III haemorrhoids in adult patients using haemorrhoid artery embolization (HAE) though coil embolisation only. Any coil from Medtronic or Cook Medical will be utilised in this study.

The principle of HAE is to cut off blood supply to the haemorrhoids, which involves the insertion of a catheter via the groin or wrist to permit the delivery of coils to preclude blood flow to the haemorrhoidal arteries. This minimally invasive approach offers the benefits of reduced surgical trauma, a shorter postoperative recovery time, and the requirement of only local anaesthesia.

BRIGHT plans to recruit a maximum of 250 patients during the 2-year enrolment phase which is planned to start in 2026.

The project is funded by Medtronic (External Research Program) and Cook Medical (Investigator-sponsored Research Program).

Objective and outcome measures

The primary objective of BRIGHT is to understand the clinical effectiveness of HAE in reducing bleeding of grade II-III haemorrhoids at 12 months using the French Bleeding Score.

As secondary objectives, BRIGHT aims to evaluate the effectiveness of HAE in reducing pain and symptoms, preventing recurrence, and improving continence. Additionally, the study will assess procedural safety and postoperative recovery time. Lastly, the impact of HAE on health-related quality of life will be examined as well as the cost-effectiveness of this treatment approach.

Some secondary outcome measures to be evaluated include the patient-reported assessment of recurrence as described in the HubBle trial (ISRCTN41394716), the Haemorrhoids Severity Score, the Vaizey Incontinence Score and the EuroQol EQ-5D-5L quality of life score.

Steering Committee