NCT00823784

Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids

Prospective Randomized Trial Comparing Transanal Doppler de-Arterialization (THD) Versus Stapler Operation for 3rd Degree Hemorrhoids

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Societa Italiana di Chirurgia ColoRettale · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
PROCEDURE	Transanal doppler hemorrhoidal ligation	THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy
PROCEDURE	stapled 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

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-01-01
• Completion: 2009-07-01
• First posted: 2009-01-16
• Last updated: 2009-01-16

Locations

1 site across 1 country: Italy