Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

NCT01615575 — Not applicable, Completed, 124 participants, University of Roma La Sapienza

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

Registry	NCT01615575
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	124 (Actual)
Sponsor	University of Roma La Sapienza (Other)
Conditions	Haemorrhoids
Interventions	Transanal haemorrhoidal dearterialisation, Stapler haemorrhoidopexy (Procedure)
Dates	start 2008-10-01, primary completion 2012-04-01, completion 2012-04-01, first posted 2012-06-08, last updated 2012-06-08
Locations	1 site in United Arab Emirates

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Haemorrhoidal dearterialisation	Active comparator	Procedure: Transanal haemorrhoidal dearterialisation	Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and addiction of rectal mucopexy.
Stapler haemorrhoidopexy	Active comparator	Procedure: Stapler haemorrhoidopexy	Haemorrhoidopexy was performed with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA.)

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).

+Outcome measures

Primary outcomes

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

Secondary outcomes

Postoperative pain [24 hr]: Pain score 24 hr after operation
Complications [One month]: Intra and postoperative complication within 30 days.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
The City Hospital	Dubai	United Arab Emirates

+Investigators

Pierino Lucarelli, MD, FRCS, Principal investigator