Clinical trial NCT04621695: Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III
Official title: Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III: a Multicentre, Randomized Controlled Trial and Cost-utility Analysis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Hemorrhoids, Internal
PROM
Rectal Diseases
Keywords: Hemorrhoids
Hemorrhoidal disease
Rubber band ligation
Hemorrhoidectomy
PROM
Lead sponsor: Proctos Kliniek
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Health related quality of life
timeFrame: 24 months
measure: Recurrence
timeFrame: at 12 months
measure: In-hospital direct costs
timeFrame: this will be asked at 6 weeks, 6, 12 and 24 months
measure: In-hospital indirect costs
timeFrame: this will be asked at 6 weeks, 6, 12 and 24 months
measure: Out-of-hospital postoperative costs
timeFrame: this will be asked at 6 weeks, 6, 12 and 24 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: 12 months
measure: Patient reported outcome measures concerning symptoms in daily life; Vaizey score
timeFrame: 12 months
measure: Patient reported outcome measures concerning symptoms in daily life; proctoPROM
timeFrame: 12 months
measure: Patient reported outcome measures concerning symptoms in daily life; PROM-HISS
timeFrame: 12 months
measure: Patient reported outcome measures concerning symptoms in daily life; HHS
timeFrame: 12 months
measure: Patient reported outcome measures concerning symptoms in daily life, VAS pain score
timeFrame: this will be asked 1 day post procedure, 1 week and 6 weeks post procedure.
measure: Return to work
timeFrame: this will be asked at 1 week and 6 weeks post procedure.
measure: Need for further treatment
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander MC
city: Amsterdam
country: Netherlands
facility: OLVG
city: Amsterdam
country: Netherlands
facility: University Medical Center location AMC
city: Capelle Aan Den IJssel
country: Netherlands
facility: IJsselland ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart ziekenhuis
city: Maastricht
country: Netherlands
facility: MUMC+
city: Utrecht
country: Netherlands
facility: Centraal Militair Hospitaal
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Proctos Kliniek
name: Ingrid Han-Geurts, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center, location AMC
name: Willem Bemelman, Prof.
role: STUDY_CHAIR
References: