Hemorrhoids Clinical Trial
— THD-LIGAOfficial title:
Prospective Multicenter Randomized Trial About Transanal Hemorrhoidal Dearterialization With Mucopexy (THD) Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids
NCT number | NCT02654249 |
Other study ID # | THD_LIGA_RCT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | January 2020 |
Verified date | April 2021 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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™.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 2020 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 76 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de la Ribera | Alzira | Valencia |
Spain | Valle d'Hebron University Hospital | Barcelona | |
Spain | Galdakano Usansolo Hospital | Bizkaia | Pais Vasco |
Spain | Bellvitge University Hospital | L'Hospitalet de Llobregat | Barcelona |
Spain | Complejo Asistencial Universitario de Leon | Leon | |
Spain | Fundación Jimenez Diaz | Madrid | |
Spain | Hospital La Paz | Madrid | |
Spain | Hospital Universitario de La Princesa | Madrid | |
Spain | Hospital Universitario Rey Juan Carlos | Mostoles | Madrid |
Spain | Hospital Comarcal de Valdeorras | O Barco de Valdeorras | Ourense |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Quality of life | Quality of life by Short Form 12 (SF-12) Questionnaire | At 1 month and at 1 and 2 years after surgery | |
Secondary | 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. | At the day 15, 30 and at 1 and 2 years after surgery | |
Secondary | Post-operative morbidity | Dindo classification of complicacions will be used | within the first 30 days after surgery | |
Secondary | 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 | |
Secondary | 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 |
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