Doppler-guided or Non Doppler-guided Arterial Ligation and Mucopexy for Third Degree Hemorrhoids: That is the Question (HAMLeT)
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|ClinicalTrials.gov Identifier: NCT03729414|
Recruitment Status : Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Hemorrhoidal disease is one of the most common proctological disease affecting the general population from the mid-teens onward with considerable implications for the National Health Service (NHS) both from an economic point of view and from surgeon's workload.Improved understanding of the pathogenesis of hemorrhoids and of the complications associated with excisional hemorrhoidectomy led to the invention of newer surgical procedures, including Doppler guided hemorrhoidal artery ligation (DGHAL).
This technique was introduced in 1995 by Morinaga et al. and consists in the use of a proctoscope with a Doppler transducer that detect the arterial structures.
Since DGHAL does not involve tissue excision, it is expected to be associated with reduced postoperative pain if compared with hemorrhoidectomy.
In the last decade several devices (THD and AMI/ HAL-RAR - Hemorrhoidal Artery Ligation and Recto Anal Repair) have been developed in order to improve and facilitate the execution of the technique, making easier the procedure.
The hypothesis of the study is that a simple mucopexy procedure by suture-fixation of anal cushion without the aim of a Doppler device, could be as effective as DGHAL and mucopexy to manage prolapsing grade III hemorrhoids.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids Prolapse||Procedure: mucopexy with Doppler artery ligation Procedure: mucopexy without Doppler artery ligation||Not Applicable|
Prospective, multi-centre, parallel-arm randomized controlled equivalence trial. Eligible patients will be randomized to either mucopexy without Doppler guided artery ligation or mucopexy with doppler guided hemorroidal artery ligation.
Primary aim of the Hamlet trial is to demonstrate that mucopexy without DGHAL for grade III haemorrhoids have equivalent recurrence rate at 1 year follow up of DGHAL with mucopexy procedure
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, multi-centre, parallel-arm randomized controlled equivalence trial. Eligible patients will be randomized to either mucopexy without Doppler guided artery ligation or mucopexy with doppler guided hemorroidal artery ligation.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||long term outcome will be evaluated by a third observer unaware of the type of surgery performed|
|Official Title:||Multicenter Randomized Controlled Trial of Doppler Guided Hemorrhoid Artery Ligation (DGHAL) and Mucopexy Versus Mucopexy Alone in the Treatment of Grade III Hemorrhoids|
|Estimated Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Active Comparator: mucopexy with Doppler artery ligation
Doppler guided hemorrhoidal artery ligation and mucopexy: Group of patients with III degree hemorrhoids treated by THD or AMI device is introduced into the anal canal. The terminal branches of the rectal artery are detected by the Doppler 2-3 cm above the dentate line. The tip of the instrument is tilted and arteries ligated with a figure-of-eight suture inserted using a special needle-holder. After the haemorrhoid artery ligation, the suture is continued with 3/5 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 artery ligations (6 ligations
Procedure: mucopexy with Doppler artery ligation
Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants
Other Name: DGHAL
Experimental: mucopexy without Doppler artery ligation
Non Doppler guided hemorrhoidal artery ligation and mucopexy: A lubricating gel is applied to the tip of the THD or the AMI device and, with the patient in the lithotomy position, the proctoscope is introduced into the anal canal. the mucopexy will start at two o'clock and repeated at 4, 6 8, 10, 12, in clockwise direction
Procedure: mucopexy without Doppler artery ligation
Hemorrhoids will be treated by mucopexy alone performed in all quadrants
Other Name: NON-DGHAL
- percentage of recurrences of hemorrhoidal prolapse [ Time Frame: 1 year follow up ]Recurrence is defined as persistent or recurrent hemorrhoidal prolapse and graded according to Goligher in 4 degrees
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): NCT03729414
|Contact: Angela Accettura, md||+39.0805592107 ext +39||Angela.email@example.com|
|Contact: Donato F Altomare, MD||+39.0805592107 ext +firstname.lastname@example.org|
|Dept of Emergency and Organ transplantation - University of Bari|
|Bari, Italy, 70124|
|Contact: Donato F Altomare, MD email@example.com|
|Principal Investigator: Donato F Altomare, MD|
|Principal Investigator:||Donato F Altomare||University of Bari, Italy|