Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

Haemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615575
• Other study ID #: URomLS1
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: June 7, 2012
• Start date: October 2008
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Haemorrhoids
• Hemorrhoids

Intervention

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

Locations

Country	Name	City	State
United Arab Emirates	The City Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	A telephone interview with a structured questionnaire at a median follow-up of 42 months.	42 months
Secondary	Postoperative pain	Pain score 24 hr after operation	24 hr
Secondary	Complications	Intra and postoperative complication within 30 days.	One month