Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone

Medical University Innsbruck

Status: Completed

Conditions: Third Degree Hemorrhoids

Treatments: Device: mucopexy +/- Doppler-guided haemorrhoidal artery ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT02372981

MUI

Details and patient eligibility

About

Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise the drawbacks of the golden standard of haemorrhoidal treatment, conventional haemorrhoidectomy techniques. Ligation techniques, such as Doppler-guided haemorrhoidal artery ligation (DG-HAL), were introduced to reduce the arterial inflow of the AVP and thus prevent the haemorrhoidal zone from being part of the continence system. Apart from inappropriate application of this surgical alternative for higher grade haemorrhoids, high recurrence rates of up to 38% after DG-HAL are due to technical failure of the ligation technique itself. This is a prospective randomised controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with symptomatic grade III haemorrhoids.

Full description

All consecutive patients with symptomatic grade III haemorrhoids are randomly allocated to one of the two study arms: (A) DG-HAL with mucopexy or (B) mucopexy alone. Endpoints are pain, faecal incontinence, bleeding, residual prolapse and vascularisation of the anorectal vascular plexus. Vascularisation of the anorectal vascular plexus is assessed by transperineal contrast enhanced ultrasound.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• grade III haemorrhoids
• ≥18 years of age

Exclusion criteria

• malignant gastrointestinal disease
• inflammatory bowel disease
• any type of proctological intervention (i.e., fistula surgery)
• recurrent haemorrhoidal disease
• anorectal trauma in the history

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

DG-HAL with mucopexy

Experimental group

Description:

Mucopexy with DG-HAL is performed using a specific device consisting of a proctoscope equipped with a Doppler probe and a light source. The proctoscope model in our study has a sliding part comprising the operating window and Doppler probe for better proximal and distal movement without repositioning the proctoscope during mucopexy.

Treatment:

Device: mucopexy +/- Doppler-guided haemorrhoidal artery ligation

mucopexy alone

Active Comparator group

Description:

Mucopexy without DG-HAL is performed using the same specific device consisting of a proctoscope equipped with a Doppler probe and a light source as described above.

Treatment:

Device: mucopexy +/- Doppler-guided haemorrhoidal artery ligation