Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

Not Applicable

Completed

• Conditions: Haemorrhoids
• Interventions: Procedure: Transanal haemorrhoidal dearterialisation; Procedure: Stapler haemorrhoidopexy

• Registration Number: NCT01615575
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-07
• Last Update Submitted: 2012-06-07
• Study First Posted: 2012-06-08
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haemorrhoidal dearterialisation	Transanal haemorrhoidal dearterialisation	Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.
Stapler haemorrhoidopexy	Stapler haemorrhoidopexy	Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)

Primary Outcome Measures

Name	Time	Method
Recurrence	42 months	A telephone interview with a structured questionnaire at a median follow-up of 42 months.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	24 hr	Pain score 24 hr after operation
Complications	One month	Intra and postoperative complication within 30 days.

Trial Locations

Locations (1)

The City Hospital; 🇦🇪 Dubai, United Arab Emirates