Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

NCT ID: NCT01263431

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-04-30

Brief 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

Detailed 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

Conditions

Third Degree Hemorrhoids

Study Design

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

Study Groups

Hemorrhoidectomy

Excision of hemorrhoid cushions

Group Type: ACTIVE_COMPARATOR

Hemorrhoidectomy

Intervention Type: PROCEDURE

Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line

Hemorrhoidal dearterialization

Ligation of therminbal branches oh hemorrhoid arteries

Group Type: EXPERIMENTAL

Hemorrhoidal dearterialization

Intervention Type: PROCEDURE

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

Interventions

Hemorrhoidectomy

Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scientific Institute San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Paola De Nardi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paola De Nardi, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Scientific Institute

Locations

San Raffaele Scientific Institute

Milan, , Italy

Countries

Italy

References

De Nardi P, Capretti G, Corsaro A, Staudacher C. A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids. Dis Colon Rectum. 2014 Mar;57(3):348-53. doi: 10.1097/DCR.0000000000000085.

Reference Type: DERIVED

PMID: 24509458 (View on PubMed)

Other Identifiers

Emorroidi grado 3

Identifier Type: -

Identifier Source: org_study_id