Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

University of Roma La Sapienza

Status: Completed

Conditions: Haemorrhoids

Treatments: Procedure: Stapler haemorrhoidopexy; Procedure: Transanal haemorrhoidal dearterialisation

Study type: Interventional

Funder types: Other

Identifiers

NCT01615575

URomLS1

Details and patient eligibility

About

The aim of the present study was to compare the results of transanal haemorrhoidal dearterialisation and stapler haemorrhopidopexy in the treatment of grade III and IV haemorrhoids with a long-term follow-up.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• grade III and IV hemorrhoids requiring hemorrhoidectomy.

Exclusion criteria

• first and second degree hemorrhoids
• patients with firm and fibrotic external irreducible haemorrhoids
• thrombosed hemorrhoids; recurrent hemorrhoids after previous surgical treatment
• history of inflammatory bowel disease; history of colon, rectal or anal cancer
• inability to give informed consent
• age < 18 years
• pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Haemorrhoidal dearterialisation

Active Comparator group

Description:

Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.

Treatment:

Procedure: Transanal haemorrhoidal dearterialisation

Stapler haemorrhoidopexy

Active Comparator group

Description:

Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)

Treatment:

Procedure: Stapler haemorrhoidopexy