Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
THD-LIGA
Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
1 other identifier
interventional
80
1 country
10
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™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedApril 19, 2021
April 1, 2021
2.1 years
December 13, 2015
April 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative pain
Post-operative pain by simple verbal numerical scale (0-10), the Andersen scale (0-5) and the taken pain medicacions will be recorded by the patients on a specific book during the first thirty days after surgery.
within the first 30 days after surgery
Secondary Outcomes (5)
Quality of life
At 1 month and at 1 and 2 years after surgery
Specific disabilities (fecal incontinence and costipation)
At the day 15, 30 and at 1 and 2 years after surgery
Post-operative morbidity
within the first 30 days after surgery
Hemorrhoid recurrence
At 1 and 2 years after surgery
Satisfaction after surgery
At the day 15, 30 and at 1 and 2 years after surgery
Study Arms (2)
THD and mucopexy
OTHERPatients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD) under generla anesthesia.
Ligasure hemorroidectomy
ACTIVE COMPARATORPatients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.
Interventions
Using an anoscope combined with a Doppler transducer the hemorrhoidal arteries are identified and ligated to decrease the blood flow to the hemorrhoidal plexus. In order to reduce hemorroidal prolapse a mucopexy is performed.
Excisional hemorroidectomy performed with Ligasure™
An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure
A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Galdakano Usansolo Hospital
Bizkaia, Basque Country, 48960, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933, Spain
Hospital Comarcal de Valdeorras
O Barco de Valdeorras, Ourense, 32300, Spain
Hospital Universitario de la Ribera
Alzira, Valencia, 46600, Spain
Valle d'Hebron University Hospital
Barcelona, 08035, Spain
Complejo Asistencial Universitario de Leon
León, 24071, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Fundación Jimenez Diaz
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
Related Publications (2)
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.
PMID: 35239526DERIVEDTrenti 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.
PMID: 30807456DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastiano Biondo, MD, PhD
Bellvitge University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 13, 2015
First Posted
January 13, 2016
Study Start
December 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2020
Last Updated
April 19, 2021
Record last verified: 2021-04