Clinical trial NCT00823784: Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids
Official title: Prospective Randomized Trial Comparing Transanal Doppler de-Arterialization (THD) Versus Stapler Operation for 3rd Degree Hemorrhoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemorrhoids
Keywords: hemorrhoids
stapler
Doppler
artery ligation
outcome
recurrence
Lead sponsor: Societa Italiana di Chirurgia ColoRettale
Sponsor class: NETWORK
First posted: 2009-01-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: early complication rate (bleeding, pain) and long term outcome (symptomatic hemorrhoids recurrence) after stapled hemorrhoidopexy versus transanal hemorrhoid arteries ligation and mucopexy
timeFrame: early postoperative period (30 days) and after 1 year
Secondary outcomes:
measure: Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction
timeFrame: early postoperative period
Other outcomes:
Locations:
city: S Vito al Tagliamento
country: Italy
facility: Santa Maria dei Battuti Hospital
state: PN
Study officials:
affiliation: Societa Italiana di Chirurgia ColoRettale
name: Donato F Altomare, MD
role: STUDY_CHAIR
References:
citation: Dal Monte PP, Tagariello C, Sarago M, Giordano P, Shafi A, Cudazzo E, Franzini M. Transanal haemorrhoidal dearterialisation: nonexcisional surgery for the treatment of haemorrhoidal disease. Tech Coloproctol. 2007 Dec;11(4):333-8; discussion 338-9. doi: 10.1007/s10151-007-0376-4. Epub 2007 Dec 3.