Comparison of rubber band ligation and haemorrhoidectomy in patients with symptomatic haemorrhoids, a multicentre, randomized controlled trial and cost-utility analysis

Comparison of rubber band ligation and haemorrhoidectomy in patients with symptomatic haemorrhoids, a multicentre, randomized controlled trial and cost-utility analysis - HollAND trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55719

Enrollment

360

Registered

2019-08-01

Start date

2019-11-25

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haemorrhoids

Interventions

Rubber band ligation: Rubber band ligation, first described by Barron, is performed by a suction device that allows a rubber band to be applied at the base of the haemorrhoid via a proctoscope. Maxi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Haemorroids grade III (Golligher classification) 18 years of age and older sufficient knowledge of the Dutch language, spoken and written Obtained written informed consent

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Primary outcome measure is quality of life at 12 and 24 months measured with the EQ-5D-5L with Dutch rating; in-hospital direct and indirect costs (measured with EQ5D and cost incremental analysis) and out-of-hospital postoperative costs (measured with EQ5D and cost incremental analysis).	—

Secondary

Measure	Time frame
Patient-related outcome measures: complaint reduction (Haemorroid Symptom Score, HSS), proctology specific validated patient-related outcome measure (PROM) Vaizey faecal incontinence score visual analogue scale pain score (VAS) duration of absence from work analgesic requirement during the first three days Clinical outcomes: Complications Postoperative bleeding requiring re admittance and/or blood transfusion Urinary retention requiring catheterisation Anal fissure Emergency reoperation Anal stenosis Residual anal skintags Need for further treatment Duration of surgery Length of hospital stay recurrence within one and two years	—

Measure

Time frame

Patient-related outcome measures: complaint reduction (Haemorroid Symptom Score, HSS), proctology specific validated patient-related outcome measure (PROM) Vaizey faecal incontinence score visual analogue scale pain score (VAS) duration of absence from work analgesic requirement during the first three days Clinical outcomes: Complications Postoperative bleeding requiring re admittance and/or blood transfusion Urinary retention requiring catheterisation Anal fissure Emergency reoperation Anal stenosis Residual anal skintags Need for further treatment Duration of surgery Length of hospital stay recurrence within one and two years

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)