Prospective Randomized Trial Comparing THD Versus Stapler Operation for 3rd Degree Hemorrhoids (THD/stapler)

Societa Italiana di Chirurgia ColoRettale

Status and phase: Unknown; Phase 3

Conditions: Hemorrhoids

Treatments: Procedure: Transanal doppler hemorrhoidal ligation; Procedure: stapled hemorrhoidopexy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00823784

Siccr trial THD/stapler

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

1THD group

Experimental group

Description:

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

Treatment:

Procedure: Transanal doppler hemorrhoidal ligation

2 stapler group

Active Comparator group

Description:

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

Treatment:

Procedure: stapled hemorrhoidopexy