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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02372981
First Posted: February 26, 2015
Last Update Posted: February 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Felix Aigner, Medical University Innsbruck
  Purpose
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.

Condition Intervention
Third Degree Hemorrhoids Device: mucopexy +/- Doppler-guided haemorrhoidal artery ligation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Felix Aigner, Medical University Innsbruck:

Primary Outcome Measures:
  • pain assessment wit 1-month-pain diary [ Time Frame: 1 month ]

Enrollment: 40
Study Start Date: October 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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.
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felix Aigner, ao. Univ.-Prof. Dr. med., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02372981     History of Changes
Other Study ID Numbers: MUI
First Submitted: February 6, 2015
First Posted: February 26, 2015
Last Update Posted: February 26, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases