An interventional study of mucopexy +/- Doppler-guided haemorrhoidal artery ligation in Third Degree Hemorrhoids, sponsored by Medical University Innsbruck. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by Medical University Innsbruck · Not applicable, Interventional, and Treatment
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.
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.
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's enrollment of 40 is below the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
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 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
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.
pain assessment wit 1-month-pain diary
Time frame: 1 month
No study locations are listed for this record.
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Medical University Innsbruck