Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone
Primary Purpose
Third Degree Hemorrhoids
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mucopexy +/- Doppler-guided haemorrhoidal artery ligation
Sponsored by
About this trial
This is an interventional treatment trial for Third Degree Hemorrhoids
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DG-HAL with mucopexy
mucopexy alone
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
pain assessment wit 1-month-pain diary
Secondary Outcome Measures
Full Information
NCT ID
NCT02372981
First Posted
February 6, 2015
Last Updated
February 20, 2015
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT02372981
Brief Title
Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Third Degree Hemorrhoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DG-HAL with mucopexy
Arm Type
Experimental
Arm Description
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.
Arm Title
mucopexy alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
mucopexy +/- Doppler-guided haemorrhoidal artery ligation
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain assessment wit 1-month-pain diary
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
26787597
Citation
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.
Results Reference
derived
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Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone
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