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Completed

NCT Number: NCT01263431

Comparison Between Excisional Hemorrhoidectomy and Haemorrhoidal Dearterialisation With Anopexy

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

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Key information

Conditions

Third Degree Hemorrhoids

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Raffaele Scientific Institute

Milan, 20132, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemorrhoidectomy

Procedure

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

Hemorrhoidal dearterialization

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

Primary outcomes

  1. postoperative pain

    Time frame: 1 week

Secondary outcomes

  1. postoperative morbidity

    Time frame: 30 days

  2. resumption of working activity

    Time frame: 30 days

  3. patient's satisfaction

    Time frame: 30 days

  4. Relapse

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 20, 2010
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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