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

Hemorrhoids Clinical Trial

— THD/stapler  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00823784
• Other study ID #: Siccr trial THD/stapler
• Status: Recruiting
• Phase: Phase 3
• First received: January 15, 2009
• Last updated: January 15, 2009
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2009
• Source: Societa Italiana di Chirurgia ColoRettale
• Contact: Aldo Infantino, MD
• Phone: ++39 3356862961
• Email: ainfantino[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: July 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• Transanal doppler hemorrhoidal ligation
THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy
• 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

Locations

Country	Name	City	State
Italy	Santa Maria dei Battuti Hospital	S Vito al Tagliamento	PN

Sponsors (1)

Lead Sponsor	Collaborator
Societa Italiana di Chirurgia ColoRettale

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Epub 2007 Dec 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time to return to the working activities, costs for the public health system and the degree of patients' satisfaction		early postoperative period	No