Haemorrhoidectomy versus rubber bAND ligation in grade III haemorrhoids: HollAND trial

Not Applicable

Conditions: <p>Haemorrhoids graad III.</p>
10002112

Registration Number: NL-OMON24433

Lead Sponsor: Proctos Kliniek Bilthoven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

• Hemorrhoids grade III (Goligher classification) • Age 18 years and older • Sufficient understanding of the Dutch written language (reading and writing)

Exclusion Criteria

• Previous rectal or anal surgery with the exception of rubber band ligation • Previous surgery for haemorrhoids (at any time) • More than one injection treatment for haemorrhoids in the past 3 years • More than one rubber band ligation procedure in the past 3 years • Previous rectal radiation • Pre-existing sphincter injury • Inflammatory bowel disease • Medically unfit for surgery or for completion of the trial (ASA>III) • Pregnancy • Hyper-coagulability disorders • Therapy with Warfarin, Clopidogrel or oral anticoagulance • Patients previously randomised to this trial • Not able or willing to provide written informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br><tr><br><td>Primary outcomes are quality of life measured with the Eq-5d-5L with Dutch rating and recurrence rate measured at 12 months follow-up.</td><br></tr><br>

Secondary Outcome Measures

Name	Time	Method
<br><tr><br><td>Secondary outcomes are: complaint reduction with proctology specific patient-related outcome measure (HSS, PROM, PROMHISS), vaizey score, resumption of work, pain (VAS), complications and recurrence at two years. </td><br></tr><br><br>