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

• ClinicalTrials.gov Identifier: NCT04621695
• Recruitment Status: Unknown
• First Posted: November 9, 2020
• Last Update Posted: March 16, 2021
• Sponsor: Proctos Kliniek
• Information provided by (Responsible Party): dr. IJM Han-Geurts, Proctos Kliniek

Tracking Information

• First Submitted Date: October 23, 2020
• First Posted Date: November 9, 2020
• Last Update Posted Date: March 16, 2021
• Actual Study Start Date: November 25, 2019
• Estimated Primary Completion Date: November 25, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2020)

• Health related quality of life [ Time Frame: 24 months ]
  The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient's HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient's health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient's self-rated health with endpoints labelled 'the best health you can imagine' at the top and 'the worst health you can imagine' at the bottom.
• Recurrence [ Time Frame: at 12 months ]
  Patient self reported assessment with a dichotomous question: "At the moment, do you feel your symptoms from your haemorrhoids are: (1) cured or improved compared with before treatment; or (2) unchanged or worse compared with before treatment?" Any patient who answers '1' but has required further treatment since the initial procedure will be reclassified as '2', identified via hospital records, their consultant and patient questioning
• In-hospital direct costs [ Time Frame: this will be asked at 6 weeks, 6, 12 and 24 months ]
  with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
• In-hospital indirect costs [ Time Frame: this will be asked at 6 weeks, 6, 12 and 24 months ]
  with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.
• Out-of-hospital postoperative costs [ Time Frame: this will be asked at 6 weeks, 6, 12 and 24 months ]
  with EQ-5D-5L and cost incremental analysis (iMCQ and iPCQ): The impact of disease on the ability of a person to perform work should be part of an economic evaluation when a societal perspective is applied. iMTA is highly experienced in methods for measuring and valuing productivity losses.The Productivity Costs Questionnaire (iPCQ) may be combined with the iMTA Medical Consumption Questionnaire (iMCQ), a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 3, 2020)

• Health related quality of life [ Time Frame: 12 months ]
  The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient's HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient's health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient's self-rated health with endpoints labelled 'the best health you can imagine' at the top and 'the worst health you can imagine' at the bottom.
• Patient reported outcome measures concerning symptoms in daily life; Vaizey score [ Time Frame: 12 months ]
  Vaizey faecal continence score consists of 7 questions with a maximum of score of 24. The higher the score, the higher the worse the outcome.
• Patient reported outcome measures concerning symptoms in daily life; proctoPROM [ Time Frame: 12 months ]
  The proctoPROM is a validated questionnaire consisting of five questions concerning patients well-being, wich are each scored on a numeric rating scale from 0 to 10. Regarding impact of symptoms, 0 correlates with 'no impact at all' and 10 with 'highly impacted on daily life'. Than the mean of the 5 question is taken.
• Patient reported outcome measures concerning symptoms in daily life; PROM-HISS [ Time Frame: 12 months ]
  Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score which are each scored on a numeric rating scale from 0 to 10. Regarding impact of symptoms, 0 correlates with 'no impact at all' and 10 with 'highly impacted on daily life'. For patient satisfaction with treatment, this ranges between 0 'not satisfied' and 10 'very satisfied'.
• Patient reported outcome measures concerning symptoms in daily life; HHS [ Time Frame: 12 months ]
  Hemorrhoid severity score consists of five questions concerning the frequency of symptoms of hemorrhoids. The higher the score the more frequent the symptoms occur.
• Patient reported outcome measures concerning symptoms in daily life, VAS pain score [ Time Frame: this will be asked 1 day post procedure, 1 week and 6 weeks post procedure. ]
  The pain visual analogue scale has a numeric rating scale from 0 to 10 with 0 being 'no pain' and 10 'worse pain you ever felt'.
• Return to work [ Time Frame: this will be asked at 1 week and 6 weeks post procedure. ]
  Number of days patients are able to return to work
• Need for further treatment [ Time Frame: 12 months ]
• Complications [ Time Frame: 12 months ]
  Adverse events as: peroperative bleeding, postoperative bleeding, urinary retention requiring catheterisation, pelvic sepsis, anal fissure, anal fistula, wound discharge, residual anal skintages, anal stenosis, fecal incontinence, death

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hemorrhoids
• Hemorrhoids, Internal
• PROM
• Rectal Diseases

Intervention

• Procedure: RBL
  Both arms are standard care procedures in the Netherlands
• Procedure: Hemorrhoidectomy
  Both arms are standard care procedures in the Netherlands

Study Arms

• Rubber band ligation
  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.
  Intervention: Procedure: RBL
• Hemorrhoidectomy

  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.

  Intervention: Procedure: Hemorrhoidectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 3, 2020): 360
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 25, 2023
• Estimated Primary Completion Date: November 25, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT04621695
• Other Study ID Numbers: NL69227.018.19
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: (Several versions of) processed data, documentation of the research process, including deindentified participant data, raw data, syntaxes
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: 3 months embargo due to publishing.
• Access Criteria: There will be access restrictions to my data collection. A request must be made at Data Access Committee (DAC).

• Current Responsible Party: dr. IJM Han-Geurts, Proctos Kliniek
• Original Responsible Party: Same as current
• Current Study Sponsor: Proctos Kliniek
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ingrid Han-Geurts, MD PhD; Proctos Kliniek
• Study Chair: Willem Bemelman, Prof.; Amsterdam University Medical Center, location AMC

• PRS Account: Proctos Kliniek
• Verification Date: March 2021