Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids (THD-LIGA)

Catalan Institute of Health

Status: Completed

Conditions: Hemorrhoids

Treatments: Device: THD anoscope and doppler; Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).; Device: Ligasure Vessel Sealing; Procedure: Ligasure™ hemorrhoidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02654249

THD_LIGA_RCT

Details and patient eligibility

About

The study evaluates postoperative pain, morbidity, recurrence and quality of life, comparing two different strategies in the treatment of grade III and IV hemorrhoids: transanal hemorrhoidal dearterialization with mucopexy (THD) versus hemorrhoidectomy by Ligasure™.

Full description

Transanal hemorrhoidal dearterialization (THD)‪ uses a specially developed anoscope combined with a Doppler transducer to identify the hemorrhoidal arteries. A suture ligation is performed to effectively decrease the blood flow to the hemorrhoidal plexus. In case of redundant prolapse, the prolapsed mucosa is lifted (mucopexy). THD procedure is performed without any incisions or removal of the hemorrhoidal tissue and moreover the suture line is above the dentate line, so post-operative pain and morbidities seem to be minimized in these patients. This technique differs from Ligasure hemorrhoidectomy, which focuses on excising the hemorrhoidal tissue.

This prospective, randomized, multicenter and controlled trial compares post-operative pain, morbidities, quality of life, fecal incontinence and recurrence rate in patients treated for grade III and IV hemorrhoids with THD with mucopexy versus Ligasure hemorrhoidectomy.

Enrollment: 80 patients

Sex: All

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with grade III and IV hemorrhoids according to Goligher classification
• Patients ASA I, II or III and adequate hematological, renal and hepatic function
• Patients who signed informed consent

Exclusion criteria

• Altered cognitive state that prevents collaboration in the study or patients who can neither read nor write
• Fecal incontinence
• Anal sphincter lesions
• Recurrent hemorrhoids after previous surgical tratment
• Previous anorectal surgery except banding, botulinum toxin injection and thrombectomy for hemorrhoid thrombosis
• Injection sclerotherapy during the last five years
• Concomitant anorectal disease (anal fistula, anal fissure, anal stenosis, rectocele, enterocele, anal condilomatosis).
• Concomitant diagnosis of functional pelvic floor disease, inflammatory bowel disease and previous pelvic radiotherapy
• Concomitant diagnosis of colorectal neoplasia or other neoplasia
• Patients ASA IV, V
• NSAIDs, Paracetamol, Tramadol, Metamizol and Petidine allergy
• Coagulation disorders
• Pregnancy and lactation
• Rejection of the patient to sign the consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

THD and mucopexy

Other group

Description:

Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD)‪ under generla anesthesia.

Treatment:

Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).

Device: THD anoscope and doppler

Ligasure hemorroidectomy

Active Comparator group

Description:

Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.

Treatment:

Device: Ligasure Vessel Sealing

Procedure: Ligasure™ hemorrhoidectomy