Hemorrhoids
Conditions
Keywords
hemorrhoids, stapler, Doppler, artery ligation, outcome, recurrence
Brief summary
Haemorrhoids have, in literature, extremely high ranges of prevalence, 4,4% to 36% and there is a debate on the best treatment for III degree hemorrhoids. The Stapled Hemorrhoidopexy is indicated in grade III haemorrhoids due to its advantages vs. other techniques in pain reduction and time before resume of normal activity. The new technique of Doppler guided trans-anal arterial ligation (THD) appear to be another important therapeutic tool thanks to its scarce complications, the minimally invasive procedure and efficacy of the short term results. The rationale of the two surgical techniques is different: in fact, the Stapled Hemorrhoidopexy is based on the hypothesis that the mucosal and sub/mucosal resection and stapling can cure the prolapse, etiologic factor of haemorrhoids; on the other hand, the interruption of the arterial inflow of hemorrhoids by THD reduces hemorrhoidal tissue. Aim of this study is to compare 2 techniques: The doppler guided transanal haemorrhoidal dearterialisation with the THD device and the stapled Haemorrhoidopexy (according to Longo) for III degree (Goligher) haemorrhoid, not regarding the number of prolapsed piles
Detailed description
After informed consent 284 patients with III degree hemorrhoids from 10 colorectal units will be randomized into two groups: stapler vs doppler guided transanal hemorrhoidal dearterialisation with the THD device.The early and long term outcome, as well as other secondary outcomes (costs, return to work and degree of satisfaction) will be recorded and compared.
Interventions
PROCEDURETransanal doppler hemorrhoidal ligation
THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy
PROCEDUREstapled hemorrhoidopexy
Staple hemorrhoidopexy involves resection of a ring of low rectal mucosa an lifting the hemorrhoids up in the anal canal with a stapled suture
Sponsors
Societa Italiana di Chirurgia ColoRettale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* III degree hemorrhoids * both sex * age between 18 and 70 years * ability to understand the procedure * written informed consent
Exclusion criteria
* previous surgery for hemorrhoids * fecal incontinence * obstructed defecation * other active anorectic diseases * irritable bowel syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| early complication rate (bleeding, pain) and long term outcome (symptomatic hemorrhoids recurrence) after stapled hemorrhoidopexy versus transanal hemorrhoid arteries ligation and mucopexy | early postoperative period (30 days) and after 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction | early postoperative period |
Countries
Italy
Contacts
Primary ContactAldo Infantino, MD
Outcome results
None listed