Hemorrhoid Artery LigatioN Without Doppler Trial
HAND
Hemorrhoidal Artery Ligation With Doppler Guidance vs Digital Guidance for Grade II-III Hemorrhoidal Disease Treatment: Randomized Controlled Trial
1 other identifier
interventional
200
1 country
1
Brief Summary
Hemorrhoidal artery ligation with Doppler guidance (HAL) and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment. The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection. In this ongoing randomized, controlled, single center clinical study 200 patients randomly divided into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity (VAS), treatment satisfaction (1 to 5 points) and need for the drug therapy in 30 days and 8 weeks after surgery. Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2019
CompletedFirst Submitted
Initial submission to the registry
October 6, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2021
CompletedMarch 25, 2020
March 1, 2020
1.8 years
October 6, 2019
March 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence
The rate of recurrence of any of initial symptoms or appearance of any new symptom of hemorrhoidal disease: anal bleeding during defecation, prolapse of hemorrhoidal piles or both.
2 weeks - 1 year
Secondary Outcomes (2)
Pain score
2 weeks
Patients satisfaction level
6 month and 1 year
Study Arms (2)
doppler-guided
ACTIVE COMPARATORligation of hemorrhoidal arteries with doppler guidance
finger-guided group
EXPERIMENTALligation of hemorrhoidal arteries without doppler guidance but with finger detection
Interventions
Ligation: a lubricating gel is applied to the tip of the Transanal Hemorrhoidal Dearterialization device and, with the patient in the lithotomy position, the proctoscope is introduced into the anal canal. The terminal branches of the superior rectal artery are detected by the doppler signal 2-3 cm above the dentate line. The tip of the instrument is gently tilted and the arteries are ligated with a Z-shaped stitch using 2:0 braided polyglycolic acid suture inserted using a special needle-holder through an aperture in the operating proctoscope. Mucopexy: after the haemorrhoid artery ligation, the suture is continued with three to five sutures applied 5 mm apart, making sure that the last is at least 5 mm above the dentate line. The suture is then tied to create a hemorrhoidopexy. The procedure is repeated after all detected artery ligations.
Ligation: the exact placement of all terminal branches of the superior rectal artery are found by intraoperative palpation at anal clock 2-3cm above the anorectal junction. Then arteries are ligated with Z-shaped suture using 2:0 braided polyglycolic suture. Mucopexy is then performed in the same technique as in comparative group
Eligibility Criteria
You may qualify if:
- Symptomatic grade II and III hemorrhoids according to Golligher.
- No other source of anal bleeding than hemorrhoids due to total colonoscopy
- Written voluntary informed consent
You may not qualify if:
- Any previous hemorrhoid surgery (including mini invasive procedures)
- Anal fistula
- Chronic anal fissure with severe spasm of anal sphincters
- Any stage colorectal cancer
- Oral anticoagulants for congenital disorders of the coagulation system
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic of Colorectal and Minimally invasive surgery
Moscow, 119435, Russia
Related Publications (5)
Aigner F, Bodner G, Conrad F, Mbaka G, Kreczy A, Fritsch H. The superior rectal artery and its branching pattern with regard to its clinical influence on ligation techniques for internal hemorrhoids. Am J Surg. 2004 Jan;187(1):102-8. doi: 10.1016/j.amjsurg.2002.11.003.
PMID: 14706597RESULTBrown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A, Hind D; HubBLe Study team. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids (HubBLe): a multicentre, open-label, randomised controlled trial. Lancet. 2016 Jul 23;388(10042):356-364. doi: 10.1016/S0140-6736(16)30584-0. Epub 2016 May 25.
PMID: 27236344RESULTHoyuela C, Carvajal F, Juvany M, Troyano D, Trias M, Martrat A, Ardid J, Obiols J. HAL-RAR (Doppler guided haemorrhoid artery ligation with recto-anal repair) is a safe and effective procedure for haemorrhoids. Results of a prospective study after two-years follow-up. Int J Surg. 2016 Apr;28:39-44. doi: 10.1016/j.ijsu.2016.02.030. Epub 2016 Feb 10.
PMID: 26876958RESULTMorinaga K, Hasuda K, Ikeda T. A novel therapy for internal hemorrhoids: ligation of the hemorrhoidal artery with a newly devised instrument (Moricorn) in conjunction with a Doppler flowmeter. Am J Gastroenterol. 1995 Apr;90(4):610-3.
PMID: 7717320RESULTRatto C, Campenni P, Papeo F, Donisi L, Litta F, Parello A. Transanal hemorrhoidal dearterialization (THD) for hemorrhoidal disease: a single-center study on 1000 consecutive cases and a review of the literature. Tech Coloproctol. 2017 Dec;21(12):953-962. doi: 10.1007/s10151-017-1726-5. Epub 2017 Nov 24.
PMID: 29170839RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Petr Tsarkov, Prof
Russian Society of Colorectal Surgeons
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2019
First Posted
October 8, 2019
Study Start
January 8, 2019
Primary Completion
October 10, 2020
Study Completion
January 11, 2021
Last Updated
March 25, 2020
Record last verified: 2020-03