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Completed

NCT Number: NCT01615575

Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

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.

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Key information

Conditions

Haemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The City Hospital

Dubai, P O Box 505004, United Arab Emirates

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Transanal haemorrhoidal dearterialisation

Procedure

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

Stapler haemorrhoidopexy

Procedure

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

Primary outcomes

  1. Recurrence

    Time frame: 42 months

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

Secondary outcomes

  1. Postoperative pain

    Time frame: 24 hr

    Pain score 24 hr after operation

  2. Complications

    Time frame: One month

    Intra and postoperative complication within 30 days.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy. A Randomized Trial With Long-term Follow-up

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2012
Registry last updated
Jun 8, 2012

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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