Haemorrhoids
Conditions
Brief 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.
Interventions
PROCEDURETransanal haemorrhoidal dearterialisation
Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and a rectal mucopexy
PROCEDUREStapler haemorrhoidopexy
Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 42 months | A telephone interview with a structured questionnaire at a median follow-up of 42 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24 hr | Pain score 24 hr after operation |
| Complications | One month | Intra and postoperative complication within 30 days. |
Countries
United Arab Emirates
Outcome results
None listed