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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™.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THD and mucopexy | Other | Patients will undergo to transanal hemorrhoidal dearterialization with mucopexy (THD) under generla anesthesia. |
|
| Ligasure hemorroidectomy | Active Comparator | Patients will undergo to Ligasure™ hemorroidectomy under generla anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life by Short Form 12 (SF-12) Questionnaire | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastiano Biondo, MD, PhD | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellvitge University Hospital | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | ||
| Galdakano Usansolo Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35239526 | Derived | 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. | |
| 30807456 |
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|
| Ligasure™ hemorrhoidectomy | Procedure | Excisional hemorroidectomy performed with Ligasure™ |
|
| THD anoscope and doppler | Device | An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure |
|
| Ligasure Vessel Sealing | Device | A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy |
|
| At the day 15, 30 and at 1 and 2 years after surgery |
| Post-operative morbidity | Dindo classification of complicacions will be used | 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 | 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. | At the day 15, 30 and at 1 and 2 years after surgery |
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015150 | Echocardiography, Doppler |
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
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