Comparison of rubber band ligation and haemorrhoidectomy in patients with symptomatic haemorrhoids, a multicentre, randomized controlled trial and cost-utility analysis
- Conditions
- haemorrhoids10002112
- Registration Number
- NL-OMON55719
- Lead Sponsor
- Proctos Kliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 360
Haemorroids grade III (Golligher classification)
18 years of age and older
sufficient knowledge of the Dutch language, spoken and written
Obtained written informed consent
Previous rectal or anal surgery with the exception of rubber band ligation
Patients that have had previous surgery for haemorrhoids (at any time);
patients that have had more than one injection treatment for haemorrhoids in
the past 3 years;
patients that have had more than one rubberband 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
patients with hyper-coagulability disorders
Patients that are unable to give full informed consent
Patients previously randomised to this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure is quality of life at 12 and 24 months measured with<br /><br>the EQ-5D-5L with Dutch rating; in-hospital direct and indirect costs (measured<br /><br>with EQ5D and cost incremental analysis) and out-of-hospital postoperative<br /><br>costs (measured with EQ5D and cost incremental analysis).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Patient-related outcome measures:<br /><br>complaint reduction (Haemorroid Symptom Score, HSS),<br /><br>proctology specific validated patient-related outcome measure (PROM)<br /><br>Vaizey faecal incontinence score<br /><br>visual analogue scale pain score (VAS)<br /><br>duration of absence from work<br /><br>analgesic requirement during the first three days<br /><br>Clinical outcomes:<br /><br>Complications<br /><br>Postoperative bleeding requiring re admittance and/or blood transfusion<br /><br>Urinary retention requiring catheterisation<br /><br>Anal fissure<br /><br>Emergency reoperation<br /><br>Anal stenosis<br /><br>Residual anal skintags<br /><br>Need for further treatment<br /><br>Duration of surgery<br /><br>Length of hospital stay<br /><br>recurrence within one and two years</p><br>