NCT02372981

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

Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone for the Treatment of Grade III Haemorrhoids: A Prospective-randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Third Degree Hemorrhoids

Interventions

Type	Name	Description
DEVICE	mucopexy +/- Doppler-guided haemorrhoidal artery ligation	Mucopexy with or without 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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-02-26
• Last updated: 2015-02-26