Clinical trial NCT02654249: Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
Official title: Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Keywords: Hemorrhoids grade III and IV
transanal hemorrhoidal dearterialization
hemorroidectomy
THD
LigaSure
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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™.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative pain
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: Quality of life
timeFrame: At 1 month and at 1 and 2 years after surgery
measure: Specific disabilities (fecal incontinence and costipation)
timeFrame: At the day 15, 30 and at 1 and 2 years after surgery
measure: Post-operative morbidity
timeFrame: within the first 30 days after surgery
measure: Hemorrhoid recurrence
timeFrame: At 1 and 2 years after surgery
measure: Satisfaction after surgery
timeFrame: At the day 15, 30 and at 1 and 2 years after surgery
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Bellvitge University Hospital
state: Barcelona
city: Mostoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: O Barco de Valdeorras
country: Spain
facility: Hospital Comarcal de Valdeorras
state: Ourense
city: Bizkaia
country: Spain
facility: Galdakano Usansolo Hospital
state: Pais Vasco
city: Alzira
country: Spain
facility: Hospital Universitario de la Ribera
state: Valencia
city: Barcelona
country: Spain
facility: Valle d'Hebron University Hospital
city: Leon
country: Spain
facility: Complejo Asistencial Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
affiliation: Bellvitge University Hospital
name: Sebastiano Biondo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trenti L, Biondo S, Espin-Basany E, Barrios O, Sanchez-Garcia JL, Landaluce-Olavarria A, Bermejo-Marcos E, Garcia-Martinez MT, Alias Jimenez D, Jimenez F, Alonso A, Manso MB, Kreisler E; THDLIGA-RCT Study Group. Transanal Hemorrhoidal Dearterialization With Mucopexy Versus Vessel-Sealing Device Hemorrhoidectomy for Grade III to IV Hemorrhoids: Long-term Outcomes From the THDLIGA Randomized Controlled Trial. Dis Colon Rectum. 2023 Aug 1;66(8):e818-e825. doi: 10.1097/DCR.0000000000002272. Epub 2022 Mar 1.
citation: Trenti L, Biondo S, Kreisler Moreno E, Sanchez-Garcia JL, Espin-Basany E, Landaluce-Olavarria A, Bermejo-Marcos E, Garcia-Martinez MT, Alias Jimenez D, Jimenez F, Alonso A, Manso MB; THDLIGA-RCT Study Group. Short-term Outcomes of Transanal Hemorrhoidal Dearterialization With Mucopexy Versus Vessel-Sealing Device Hemorrhoidectomy for Grade III to IV Hemorrhoids: A Prospective Randomized Multicenter Trial. Dis Colon Rectum. 2019 Aug;62(8):988-996. doi: 10.1097/DCR.0000000000001362.