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

Phase 3

• Conditions: Hemorrhoids
• Interventions: Procedure: Transanal doppler hemorrhoidal ligation; Procedure: stapled hemorrhoidopexy

• Registration Number: NCT00823784
• Lead Sponsor: Societa Italiana di Chirurgia ColoRettale

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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Last Update Submitted: 2009-01-15
• Study First Posted: 2009-01-16
• Last Update Posted: 2009-01-16
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1THD group	Transanal doppler hemorrhoidal ligation	Series of 135 patients with 3rd degree Hemorrhoids treated by THD device under spinal anaesthesia
2 stapler group	stapled hemorrhoidopexy	135 patients with 3rd degree hemorrhoids will be treated by staple hemorrhoidopexy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction	early postoperative period

Trial Locations

Locations (1)

Santa Maria dei Battuti Hospital; 🇮🇹 S Vito al Tagliamento, PN, Italy