Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids (THD-LIGA)
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|ClinicalTrials.gov Identifier: NCT02654249|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Device: Transanal hemorrhoidal dearterialization + mucopexy (THD). Procedure: Ligasure™ hemorrhoidectomy Device: THD anoscope and doppler Device: Ligasure Vessel Sealing||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||December 2019|
THD and mucopexy
Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD) under generla anesthesia.
Device: 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 anoscope and doppler
An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure
Active Comparator: Ligasure hemorroidectomy
Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia.
Procedure: Ligasure™ hemorrhoidectomy
Excisional hemorroidectomy performed with Ligasure™
Device: Ligasure Vessel Sealing
A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy
- 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.
- Quality of life [ Time Frame: At 1 month and at 1 and 2 years after surgery ]Quality of life by Short Form 12 (SF-12) Questionnaire
- Specific disabilities (fecal incontinence and costipation) [ Time Frame: At the day 15, 30 and at 1 and 2 years after surgery ]Fecal incontinence by Vaizey Score and need of laxatives. Anorecatal manometry and endoanal ultrasonography will be performed two month after surgery.
- Post-operative morbidity [ Time Frame: within the first 30 days after surgery ]Dindo classification of complicacions will be used
- Hemorrhoid recurrence [ Time Frame: At 1 and 2 years after surgery ]rectal bleeding, anal pain, mucosal prolaps will be invastigated one year after hemorroidectomy. Needing of further surgery for hemorrhoids recurrence will be recorded
- Satisfaction after surgery [ Time Frame: At the day 15, 30 and at 1 and 2 years after surgery ]A scale of 0-3 (0, not satisfied; 1 few satisfied, 2 satisfied, 3, very satisfied) will be used.
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): NCT02654249
|Bellvitge University Hospital|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Hospital Universitario Rey Juan Carlos|
|Mostoles, Madrid, Spain, 28933|
|Hospital Comarcal de Valdeorras|
|O Barco de Valdeorras, Ourense, Spain, 32300|
|Galdakano Usansolo Hospital|
|Bizkaia, Pais Vasco, Spain, 48960|
|Hospital Universitario de la Ribera|
|Alzira, Valencia, Spain, 46600|
|Valle d'Hebron University Hospital|
|Barcelona, Spain, 08035|
|Complejo Asistencial Universitario de Leon|
|Leon, Spain, 24071|
|Hospital Universitario de La Princesa|
|Madrid, Spain, 28006|
|Fundación Jimenez Diaz|
|Madrid, Spain, 28040|
|Hospital La Paz|
|Madrid, Spain, 28046|
|Principal Investigator:||Sebastiano Biondo, MD, PhD||Bellvitge University Hospital|