Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemorrhoid Artery LigatioN Without Doppler Trial (HAND)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119401
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Russian Society of Colorectal Surgeons

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.


Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: doppler-guided hemorrhoidal artery ligation Procedure: Finger-guided hemorrhoidal artery ligation Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Daniil Markaryan, MD +79035329245 markaryan@kkmx.ru
Contact: Inna Tulina, MD +79264086672 tulina@kkmx.ru

Locations
Layout table for location information
Russian Federation
Clinic of Colorectal and Minimally invasive surgery Recruiting
Moscow, Russian Federation, 119435
Contact: Inna Tulina, MD    +79264086672    tulina@kkmx.ru   
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         
Sponsors and Collaborators
Russian Society of Colorectal Surgeons
Investigators
Layout table for investigator information
Principal Investigator: Petr Tsarkov, Prof Russian Society of Colorectal Surgeons

Publications of Results:

Layout table for additonal information
Responsible Party: Russian Society of Colorectal Surgeons
ClinicalTrials.gov Identifier: NCT04119401    
Other Study ID Numbers: 683473
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Russian Society of Colorectal Surgeons:
hemorrhoids
hemorrhoidal piles
prolapse
doppler guided ligation
finger-guided artery ligation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases