HemorrhoidsTHD-LIGANCT02654249
Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
A study testing Transanal hemorrhoidal dearterialization + mucopexy (THD)., Ligasure™ hemorrhoidectomy and THD anoscope and doppler in people with Hemorrhoids, run by Hospital Universitari de Bellvitge at 10 sites in Spain.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Transanal hemorrhoidal dearterialization + mucopexy (THD)., Ligasure™ hemorrhoidectomy and THD anoscope and doppler
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesSpain
- Study dates
- Dec 2015to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitario de la Ribera
Alzira, Valencia, 46600
Valle d'Hebron University Hospital
Barcelona, 08035
Galdakano Usansolo Hospital
Bizkaia, Basque Country, 48960
Bellvitge University Hospital
L'Hospitalet de Llobregat, Barcelona, 08907
Complejo Asistencial Universitario de Leon
León, 24071
Hospital Universitario de La Princesa
Madrid, 28006
Fundación Jimenez Diaz
Madrid, 28040
Hospital La Paz
Madrid, 28046
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28933
Hospital Comarcal de Valdeorras
O Barco de Valdeorras, Ourense, 32300
About this study
Official title: Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
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™.
Read the 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.
- Conditions
- Hemorrhoids
- Being tested
- Transanal hemorrhoidal dearterialization + mucopexy (THD)., Ligasure™ hemorrhoidectomy, THD anoscope and doppler, Ligasure Vessel Sealing
- Keywords
- Hemorrhoids grade III and IV, transanal hemorrhoidal dearterialization, hemorroidectomy, THD, LigaSure
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal hemorrhoidal dearterialization + mucopexy (THD).Device
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.
Ligasure™ hemorrhoidectomyProcedure or surgery
Excisional hemorroidectomy performed with Ligasure™
THD anoscope and dopplerDevice
An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure
Ligasure Vessel SealingDevice
A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy
| Study group | Role | What they receive |
|---|---|---|
| THD and mucopexy | Other | Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD) under generla anesthesia. Receives: Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).; Device: THD anoscope and doppler |
| Ligasure hemorroidectomy | Active comparator | Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia. Receives: Procedure: Ligasure™ hemorrhoidectomy; Device: Ligasure Vessel Sealing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 30 days after surgery
Secondary outcomes (5)
Quality of life
Quality of life by Short Form 12 (SF-12) Questionnaire
Measured: At 1 month and at 1 and 2 years after surgery
Specific disabilities (fecal incontinence and costipation)
Fecal incontinence by Vaizey Score and need of laxatives. Anorecatal manometry and endoanal ultrasonography will be performed two month after surgery.
Measured: At the day 15, 30 and at 1 and 2 years after surgery
Post-operative morbidity
Dindo classification of complicacions will be used
Measured: within the first 30 days after surgery
Hemorrhoid recurrence
rectal bleeding, anal pain, mucosal prolaps will be invastigated one year after hemorroidectomy. Needing of further surgery for hemorrhoids recurrence will be recorded
Measured: At 1 and 2 years after surgery
Satisfaction after surgery
A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.
Measured: At the day 15, 30 and at 1 and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2018
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastiano Biondo, Hospital Universitari de Bellvitge
- Investigators
- Sebastiano Biondo, MD, PhD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654249
- Sponsor's protocol ID
- THD_LIGA_RCT
- Acronym
- THD-LIGA
- Status last verified
- Apr 2021
- First submitted
- 13 Dec 2015
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35239526Trenti 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.
PubMed 30807456
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
- ClinicalTrials.gov ID
- NCT02654249
- Acronym / sponsor ID
- THD-LIGA / THD_LIGA_RCT
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids grade III and IV, transanal hemorrhoidal dearterialization, hemorroidectomy, THD, LigaSure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THD and mucopexy | Other | Device: Transanal hemorrhoidal dearterialization + mucopexy (THD)., Device: THD anoscope and dopplerPatients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD) under generla anesthesia. |
| Ligasure hemorroidectomy | Active comparator | Procedure: Ligasure™ hemorrhoidectomy, Device: Ligasure Vessel SealingPatients will undergo to Ligasure™ hemorroidectomy under generla anesthesia. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transanal hemorrhoidal dearterialization + mucopexy (THD).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. | Device | THD and mucopexy |
| Ligasure™ hemorrhoidectomyExcisional hemorroidectomy performed with Ligasure™ | Procedure or surgery | Ligasure hemorroidectomy |
| THD anoscope and dopplerAn dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure | Device | THD and mucopexy |
| Ligasure Vessel SealingA curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy | Device | Ligasure hemorroidectomy |
Primary outcome
Post-operative pain
Time frame: within the first 30 days after surgery
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.
5 secondary outcomes
Quality of life
Time frame: At 1 month and at 1 and 2 years after surgery
Specific disabilities (fecal incontinence and costipation)
Time frame: At the day 15, 30 and at 1 and 2 years after surgery
Post-operative morbidity
Time frame: within the first 30 days after surgery
Hemorrhoid recurrence
Time frame: At 1 and 2 years after surgery
Satisfaction after surgery
Time frame: At the day 15, 30 and at 1 and 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 35239526Trenti 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.
- Derived from this study: PubMed 30807456Trenti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastiano Biondo, MD, PhD principal investigator
Hospital Universitari de Bellvitge
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal hemorrhoidal dearterialization + mucopexy (THD)., Ligasure™ hemorrhoidectomy and THD anoscope and doppler in people with Hemorrhoids, run by Hospital Universitari de Bellvitge at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654249, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.