Hemorrhoid Artery LigatioN Without Doppler Trial

Hemorrhoids Clinical Trial

— HAND  

Official title:

Hemorrhoidal Artery Ligation With Doppler Guidance vs Digital Guidance for Grade II-III Hemorrhoidal Disease Treatment: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04119401
• Other study ID #: 683473
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: January 11, 2021

Study information

• Verified date: March 2020
• Source: Russian Society of Colorectal Surgeons
• Contact: Daniil Markaryan, MD
• Phone: +79035329245
• Email: markaryan[@]kkmx.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hemorrhoidal disease (HD), in its different manifestations, is not only the most frequented grounds of referring for medical attention, but also one of the reasons for the modest deterioration in the quality of life that can possibly result in temporary or permanent reduction of work capacities. Today, the doppler-guided dearterialization of hemorrhoidal arteries and the following suture-fixation mucopexy in the anal canal (synonyms: mucopexy, hemorrhoids lifting, HAL-RAR) is one of the most popular and actively studied methods of the stage II - III hemorrhoidal disease surgical treatment. A number of publications raise an issue whether it is really necessary to use a doppler while the localization of the hemorrhoidal arteries is typical in the vast majority of the observations and can be easily determined on palpation.

The aim of the study is to compare the direct and long-term results of the II - III grade HD surgical treatment with the use of two techniques of the suture ligation of the hemorrhoidal arteries with mucopexy. One of these methods is classic and widely known HAL-RAR, the other one has a principal differ in no-using the doppler to find the arteries, the surgeon defines them on palpation.

The hypothesis of the study is that the digital detection of hemorrhoidal arteries pulsation followed by suture ligation and mucopexy may be no less effective in the treatment of grade II - III hemorrhoids than the use of a doppler guide.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 11, 2021
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• doppler-guided hemorrhoidal artery ligation
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.
• Finger-guided hemorrhoidal artery ligation
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

Locations

Country	Name	City	State
Russian Federation	Clinic of Colorectal and Minimally invasive surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Society of Colorectal Surgeons

Country where clinical trial is conducted

Russian Federation, 

References & 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. — View Citation

Brown 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 (H — View Citation

Hoyuela 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-yea — View Citation

Morinaga 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. — View Citation

Ratto C, Campennì 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score	pain score after surgery will be measured by patient-reported pain level using visual scale ranging from 1 to 10 where 1 is "no pain" and 10 - is the the worst pain imaginable.	2 weeks
Secondary	Patients satisfaction level	Patients will be asked to rate their own satisfaction of the procedure on a scale from 1 to 10 (with 10 being the best) and were asked whether the procedure helped their symptoms.	6 month and 1 year