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

NCT ID: NCT00823784

Last Updated: 2009-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-07-31

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.

Conditions

Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1THD group

Series of 135 patients with 3rd degree Hemorrhoids treated by THD device under spinal anaesthesia

Group Type: EXPERIMENTAL

Transanal doppler hemorrhoidal ligation

Intervention Type: PROCEDURE

THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy

2 stapler group

135 patients with 3rd degree hemorrhoids will be treated by staple hemorrhoidopexy

Group Type: ACTIVE_COMPARATOR

stapled hemorrhoidopexy

Intervention Type: PROCEDURE

Staple hemorrhoidopexy involves resection of a ring of low rectal mucosa an lifting the hemorrhoids up in the anal canal with a stapled suture

Interventions

Transanal doppler hemorrhoidal ligation

THD technique involves identification and ligation of the terminal hemorrhoid arteries (about 6) followed by mucopexy

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

THD technique; Longo's technique

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societa Italiana di Chirurgia ColoRettale

NETWORK

Sponsor Role: lead

Responsible Party

Societa Italiana di Chirurgia ColoRettale

Principal Investigators

Donato F Altomare, MD

Role: STUDY_CHAIR

Societa Italiana di Chirurgia ColoRettale

Locations

Santa Maria dei Battuti Hospital

S Vito Al Tagliamento, PN, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Aldo Infantino, MD

Role: CONTACT

ainfantino@libero.it

++39 3356862961

Facility Contacts

Aldo Infantino, MD

Role: primary

ainfantino@libero.it

++39 3356862961

References

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.

Reference Type: BACKGROUND

PMID: 18060529 (View on PubMed)

Other Identifiers

Siccr trial THD/stapler

Identifier Type: -

Identifier Source: org_study_id