haemorrhoids piles
Conditions
Interventions
open selective haemorrhoidopexy versus circular stapled haemorrhoidopexy
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age above 18 years;Symptoms of haemorrhoidal disease 2nd to 4th grade. In case of 2nd grade haemorrhoidal disease, at least two attempts of Barron ligation must have preceded;Primary or recurrent haemorrhoidal disease;Written informed consent
Exclusion criteria
Exclusion criteria: Acute presentation (not elective) Concurrent untreated or recurrent colorectal cancer Concomitant anorectal diseases (fistula, abscess, fissure, polyps) Prior endoscopic or surgical treatment of haemorrhoids within the past 6 months Active inflammatory bowel disease Previous major anorectal surgery A history of faecal incontinence Presence of severe rectal pain ASA >3 The patient is uncooperative or is not capable to return for routine outpatient follow-up On Coumarine derivate anticoagulation or history of coagulopathy On immunosuppressant medication Pregnancy Non-consenting patients Unwilling for randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is recurrence after two years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: - Postoperative pain (VAS Score) - Early complications within 6 weeks postoperative: urinary retention, obstipation, incontinence - Complaints of urgency, tenesmus, pruritus - Patient satisfaction (VAS Score) - Operating time - Time of hospitalization - Re-admission to hospital - Time to return to work - Late complications: anal stenosis, impaired continence (Wexner Continence Score), recurrence - Re-treatment rates - Need for additional skin tag excision - Quality of life (SF-36 Health Survey questionnaire) - Cost effectiveness | — |
Countries
Netherlands
Outcome results
None listed