A prospective single-blinded randomized multi-center clinical trial comparing the clinical efficacy and patient acceptability of open selective haemorrhoidopexy with stapled haemorrhoidopexy

Withdrawn

• Conditions: haemorrhoids; piles; 10002112; 10043413

• Registration Number: NL-OMON39498
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 186

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is recurrence after two years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives:<br /><br>- Postoperative pain (VAS Score)<br /><br>- Early complications within 6 weeks postoperative: urinary retention,<br /><br>obstipation, incontinence<br /><br>- Complaints of urgency, tenesmus, pruritus<br /><br>- Patient satisfaction (VAS Score)<br /><br>- Operating time<br /><br>- Time of hospitalization<br /><br>- Re-admission to hospital<br /><br>- Time to return to work<br /><br>- Late complications: anal stenosis, impaired continence (Wexner Continence<br /><br>Score), recurrence<br /><br>- Re-treatment rates<br /><br>- Need for additional skin tag excision<br /><br>- Quality of life (SF-36 Health Survey questionnaire)<br /><br>- Cost effectiveness</p><br>