Hemorrhoid Artery LigatioN Without Doppler Trial (HAND)
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|ClinicalTrials.gov Identifier: NCT04119401|
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : March 25, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Procedure: doppler-guided hemorrhoidal artery ligation Procedure: Finger-guided hemorrhoidal artery ligation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Hemorrhoidal Artery Ligation With Doppler Guidance vs Digital Guidance for Grade II-III Hemorrhoidal Disease Treatment: Randomized Controlled Trial|
|Actual Study Start Date :||January 8, 2019|
|Estimated Primary Completion Date :||October 10, 2020|
|Estimated Study Completion Date :||January 11, 2021|
Active Comparator: doppler-guided
ligation of hemorrhoidal arteries with doppler guidance
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.
Experimental: finger-guided group
ligation of hemorrhoidal arteries without doppler guidance but with finger detection
Procedure: 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
- recurrence [ Time Frame: 2 weeks - 1 year ]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.
- Pain score [ Time Frame: 2 weeks ]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.
- Patients satisfaction level [ Time Frame: 6 month and 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119401
|Contact: Daniil Markaryan, MDfirstname.lastname@example.org|
|Contact: Inna Tulina, MDemail@example.com|
|Clinic of Colorectal and Minimally invasive surgery||Recruiting|
|Moscow, Russian Federation, 119435|
|Contact: Inna Tulina, MD +79264086672 firstname.lastname@example.org|
|Principal Investigator: Petr Tsarkov, PhD|
|Sub-Investigator: Markaryan Daniil, MD|
|Sub-Investigator: Mikhail Bredikhin, MD|
|Sub-Investigator: Tatiana Garmanova, MD|
|Sub-Investigator: Aftandil Alikperzade, MD|
|Principal Investigator:||Petr Tsarkov, Prof||Russian Society of Colorectal Surgeons|