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

NCT ID: NCT02372981

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

Third Degree Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DG-HAL with mucopexy

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.

Group Type: EXPERIMENTAL

mucopexy +/- Doppler-guided haemorrhoidal artery ligation

Intervention Type: 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.

mucopexy alone

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.

Group Type: ACTIVE_COMPARATOR

mucopexy +/- Doppler-guided haemorrhoidal artery ligation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Felix Aigner

ao. Univ.-Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 26787597 (View on PubMed)

Other Identifiers

MUI

Identifier Type: -

Identifier Source: org_study_id