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

Not Applicable

Completed

• Conditions: Third Degree Hemorrhoids
• Interventions: Device: mucopexy +/- Doppler-guided haemorrhoidal artery ligation

• Registration Number: NCT02372981
• Lead Sponsor: Medical University Innsbruck

Brief 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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-02
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-20
• Last Update Submitted: 2015-02-20
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mucopexy alone	mucopexy +/- Doppler-guided haemorrhoidal artery ligation	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.
DG-HAL with mucopexy	mucopexy +/- Doppler-guided haemorrhoidal artery ligation	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.

Primary Outcome Measures

Name	Time	Method
pain assessment wit 1-month-pain diary	1 month