Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

Third Degree Hemorrhoids Clinical Trial

Official title:

Prospective Randomized Trial on Surgical Treatment of Grade 3 Hemorrhoids: Hemorrhoidectomy Versus Doppler-guided Transanal Haemorrhoidal Dearterialisation and Anopexy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263431
• Other study ID #: Emorroidi grado 3
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2010
• Last updated: January 21, 2015
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: January 2015
• Source: Scientific Institute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

Aim of the study is to compare short term results of 2 surgical treatment for grade 3 hemorrhoidal disease, namely: pain and postoperative morbidity,complications and effectiveness within 30 days, re-starting daily and working activity, patients' satisfaction

Description:

Excisional haemorrhoidectomy is burdened by severe postoperative pain. For this reason less painful treatments have been developed, such as Doppler-guided haemorrhoidal artery ligation and stapled anopexy. Both techniques seem to be safe, causing little postoperative pain. A combination of the two techniques could possibly treat both bleeding and prolapse with minimal discomfort

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-80, candidate to surgery for 3rd degree hemorrhoids

Exclusion Criteria:

• Previous anal surgery or pelvic radiotherapy

• Fecal incontinence or obstructed defecation

• IBD, IBS

Study Design

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

Related Conditions & MeSH terms

• Hemorrhoids
• Third Degree Hemorrhoids

Intervention

Procedure:
• Hemorrhoidectomy
Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line
• Hemorrhoidal dearterialization
A special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy

Locations

Country	Name	City	State
Italy	San Raffaele Scientific Institute	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain		1 week	No
Secondary	postoperative morbidity		30 days	Yes
Secondary	resumption of working activity		30 days	No
Secondary	patient's satisfaction		30 days	No
Secondary	Relapse		24 months	No