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

Third Degree Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372981
• Other study ID #: MUI
• Status: Completed
• Phase: N/A
• First received: February 6, 2015
• Last updated: February 20, 2015
• Start date: October 2010
• Est. completion date: July 2014

Study information

• Verified date: February 2015
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Third Degree Hemorrhoids

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain assessment wit 1-month-pain diary		1 month	Yes