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

NCT02372981 | Completed DMC

• 1 other identifier: MUI
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Third Degree Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• pain assessment wit 1-month-pain diary

  1 month

Study Arms (2)

DG-HAL with mucopexy

EXPERIMENTAL

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.

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

mucopexy alone

ACTIVE COMPARATOR

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.

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

Interventions

mucopexy +/- Doppler-guided haemorrhoidal artery ligation DEVICE

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.

DG-HAL with mucopexy; mucopexy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• grade III haemorrhoids
• ≥18 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Related Publications (1)

• Aigner F, Kronberger I, Oberwalder M, Loizides A, Ulmer H, Gruber L, Pratschke J, Peer S, Gruber H. Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial. Colorectal Dis. 2016 Jul;18(7):710-6. doi: 10.1111/codi.13280.

  PMID: 26787597 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ao. Univ.-Prof. Dr. med.

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 26, 2015
• Study Start: October 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 26, 2015

Record last verified: 2015-02