Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III (HollAND)

Proctos Kliniek

Status: Unknown

Conditions: Hemorrhoids, Internal; Rectal Diseases; PROM; Hemorrhoids

Treatments: Procedure: Hemorrhoidectomy; Procedure: RBL

Study type: Interventional

Funder types: Other

Identifiers

NCT04621695

NL69227.018.19

Details and patient eligibility

About

Rationale: Haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. Given the current numerous modalities the obvious question which needs to be answered is which treatment is the best. An interesting conclusion from a recent systematic review regarding operative procedures for haemorrhoidal disease is that all procedures have their own advantages and disadvantages. There is a need for evaluating treatment from the patient's point of view and transparency in surgical and non-surgical treatment outcome. So far there is no sufficiently large trial that meets that demand.

Objective: To establish the best treatment of patients with symptomatic haemorrhoids grade III: haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. The assumption is that treatment with rubber band ligation is equally effective in comparison with haemorrhoidectomy in terms of quality of life.

Study design:Multicentre randomized controlled non-inferiority trial with cost-utility analysis. Two treatment protocols are compared: haemorrhoidectomy and rubber band ligation.

Study population: Patients aged ≥ 18 years with symptomatic haemorrhoids gr III. Patients are recruited in multiple clinics during 18-24 months.

Intervention: Participants are allocated to either rubber band ligation or haemorrhoidectomy.

Main study parameters/endpoints: Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Haemorrhoids 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
• Patients previously randomised to this trial
• Not able or willing to provide written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Rubber band ligation

Other group

Description:

Rubber band ligation is performed by a suction device that allows a rubber band to be applied at the base of the haemorrhoid via a proctoscope. Maximal suction force used is 40 mmHg. A maximum of 3-4 bands are used per session. This rubber band constricts the blood supply causing it to become ischaemic before being sloughed approximately 1-2 weeks later. The resultant fibrosis reduces any element of haemorrhoidal prolapse that may have been present. No sedation is required for this day-care procedure. Patients are asked to administer an enema 2 hours prior to the procedure.

Treatment:

Procedure: RBL

Hemorrhoidectomy

Other group

Description:

There are two main excisional procedures currently carried out: open (Milligan and Morgan) and closed (Ferguson). Both have the intention of excising the haemorrhoidal cushions. The procedure is performed under either general or spinal anaesthesia in a day-care setting. Patients were asked to administer an enema 2 hours prior to the procedure.

Treatment:

Procedure: Hemorrhoidectomy