Hemorrhoids
Conditions
Keywords
Hemorrhoids grade III and IV, transanal hemorrhoidal dearterialization, hemorroidectomy, THD, LigaSure
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™.
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.
Interventions
DEVICETransanal 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.
PROCEDURELigasure™ hemorrhoidectomy
Excisional hemorroidectomy performed with Ligasure™
DEVICETHD 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
DEVICELigasure Vessel Sealing
A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy
Sponsors
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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) | 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 | within the first 30 days after surgery | Dindo classification of complicacions will be used |
| Hemorrhoid recurrence | 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 | 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. |
Countries
Spain
Outcome results
None listed