HemorrhoidsNCT04101773
Napoleon Trial: Optimal Treatment for Recurrent Haemorrhoidal Disease
A study testing RBL versus sutured mucopexy versus haemorrhoidectomy. in people with Hemorrhoids, run by Maastricht University Medical Center at 16 sites in Netherlands.
Trial summary
Rationale: There is level I evidence in literature that the first management step of HD is basic treatment, including laxatives and high fibre dieti, ii. The next treatment modality after basic treatment in case of persistent symptoms is rubber band ligation (RBL), which can be repeated if necessary. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- RBL versus sutured mucopexy versus haemorrhoidectomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 16 sitesNetherlands
- Study dates
- 1 Mar 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or older
- Recurrent grade 2 or 3 HD
- Patients underwent at least 2 RBL treatments in the last 3 years based on hospital electronic patient file (EPD)
- Eligible for e-mail questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
- Obtained written informed consent
Who cannot join
- Previous rectal or anal surgery with the exception of rubber band ligation
- Patients that have had previous surgery treatment for HD (at any time)
- Previous rectal radiation
- Pre-existing sphincter injury
- Pathologies of the colon and rectum
- Medically unfit for surgery or for completion of the trial (ASA>III)
Show all 10Show fewer
- Pregnancy
- Patients with hypercoagulability disorders
- Patients using Warfarin or Clopidogrel or oral anticoagulance therapy
- Patients that are unable to give full informed consent
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Netherlands16 sites
Ziekenhuisgroep Twente
Almelo
Lutke Holzink
Meander Medisch Centrum
Amersfoort
Consten
Onze Lieve Vrouwe Gasthuis
Amsterdam
DeCastro
Gelre Ziekenhuizen
Apeldoorn
Duijvendijk
Rijnstate Ziekenhuis
Arnhem
Vening
IJsselland Ziekenhuis
Capelle aan den IJssel
Doornebosch
Reinier de Graaf Gasthuis
Delft
Dekker
Groene Hart Ziekenhuis
Gouda
Baeten
Elkerliek Ziekenhuis
Helmond
Schipper
Medisch Centrum Leeuwarden
Leeuwarden
Koopal
Maastricht University Medical Centre
Maastricht, Limburg, 6229HX
Sara Kuiper, MD, +31(0)626731279, s.kuiper@maastrichtuniversity.nl
Stephanie Breukink, MD PhD, +31(0)43-3872807, s.breukink@mumc.nl
Canisius Wilhelmina Ziekenhuis
Nijmegen
Hansson
Laurentius Ziekenhuis
Roermond
Heemskerk
Diakonessenhuis
Utrecht
Pronk
Máxima Medisch Centrum
Veldhoven
Dielen
VieCurie Medisch Centrum
Venlo
Vogelaar
About this study
Official title: Cost-effectiveness and Effectiveness of Rubber Band Ligation Versus Sutured Mucopexy Versus Haemorrhoidectomy in Patients With Recurrent Haemorrhoidal Disease: a Multicentre,Randomized Controlled Trial
Rationale: There is level I evidence in literature that the first management step of HD is basic treatment, including laxatives and high fibre dieti, ii. The next treatment modality after basic treatment in case of persistent symptoms is rubber band ligation (RBL), which can be repeated if necessary.
There is currently no consensus and a lack of evidence regarding the best treatment option for these patients having recurrent HD: continuing RBL or a surgical intervention. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group.
Read more
Objective: The primary objective of this RCT is to compare the effectiveness of RBL, sutured mucopexy and haemorrhoidectomy regarding recurrence and patient-reported symptoms for recurrent grade 2 and 3 HD after at least 2 previous RBL treatments. Secondary objectives are to compare RBL, sutured mucopexy and haemorrhoidectomy for recurrent grade 2 and 3 HD after previous RBL treatments in terms of early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs and cost-effectiveness, and budget impact.
Study design: Dutch prospective multicentre randomized controlled trial.
Study population: Patients ≥18 who have recurrent grade 2 or 3 haemorrhoidal disease and who had at least 2 rubber band ligation treatments. In total, 558 patients will be included.
Intervention: Rubber band ligation versus sutured mucopexy versus haemorrhoidectomy. All three interventions are part of Dutch usual care, and serve as each other's control.
Main study parameters/endpoints: Primary outcomes are (1) recurrence and (2) patient-reported symptoms assessed after 12 months. Secondary outcome variables are early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs, cost-effectiveness and budget-impact.
Read the detailed description
Haemorrhoidal disease (HD) is the most common type of anorectal complaint in the Netherlands, with an annual prevalence of 10% in general practice. There is level I evidence in literature that the first management step of HD is basic treatment,including laxatives and high fibre diet. The general practitioner usually offers basic treatment. If basic treatment fails patients are referred to the hospital. About 50.000 patients are referred to a hospital for HD in the Netherlands annually. The next treatment modality after basic treatment in case of persistent symptoms is rubber band ligation (RBL), which can be repeated if necessary. RBL is an easy, cheap and outpatient-based procedure. Thirty per cent of the patients, approximately 15.000 patients a year, develop recurrent symptoms after basic treatment and repeat RBL. There is currently no consensus and a lack of evidence regarding the best treatment option for these patients having recurrent HD: continuing RBL or a surgical intervention. Literature indicates that haemorrhoidectomy is the surgical treatment of choice based on outcomes like recurrencerate. The major drawback of this technique is that it is very painful and more costly compared to RBL. A relatively novel, but regular surgical alternative is the sutured mucopexy. Although hospital costs of sutured mucopexy are comparable to haemorrhoidectomy, the operation is less painful and requires less recuperation time. The recurrence rate of sutured mucopexy is ranked between that of RBL and haemorrhoidectomy.
A Dutch national survey conducted by our research group evaluating the management practices of HD demonstrated considerable variation in the best (surgical) treatment option regarding recurrent HD, resulting in potentially undesirable practice variation. The treatment of recurrent grade 2 or 3 HD currently depends on the preference and the experience of the surgeon and of the patient, without high level evidence substantiating this practice variation. This implies a need for a high quality study regarding the treatment of recurrent grade 2 or 3 HD. Diminishing this practice variation will endorse cost-effectiveness in healthcare settings.To our knowledge, this will be the first RCT worldwide comparing RBL, sutured mucopexy and haemorrhoidectomy in recurrent grade 2 or 3 HD and generating high-level evidence of the (cost-) effectiveness. The investigators consider combining 2 trials in one with a direct comparison between these three interventions to be an efficient research approach.
Up till now, trials were mostly powered on traditional outcomes like recurrence, a definition that differs widely between studies.To improve transparency between studies and facilitate the ability to compare and combine (future) studies, our research group developed a European Society of Coloproctology (ESCP) Core Outcome Set (COS) for HD. This international COS for HD selected 'patient-reported symptoms' as primary outcome. Additionally, the investigators recently developed a patient reported symptom score for HD: the PROM-HISS. This PROM is based on most cited symptoms in literature and patient interviews. The patient advisory board (PAB) of this project underlines the clinical relevance of this PROM. As the PROM-HISS has not yet been used in other studies and has to be validated, the investigators will additionally use patient-reported symptoms assessed by the PROM-HISS, next to recurrence, as primary outcome in this trial.
- Conditions
- Hemorrhoids
- Being tested
- RBL versus sutured mucopexy versus haemorrhoidectomy.
- Keywords
- hemorrhoids, haemorrhoidal disease, recurrence, rubber band ligation, haemorrhoidectomy
- Medical subject headings
- Hemorrhoids, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBL versus sutured mucopexy versus haemorrhoidectomy.Procedure or surgery
All 3 interventions are part of Dutch usual care, and serve as each other's control.
| Study group | Role | What they receive |
|---|---|---|
| Rubber Band Ligation (RBL) | Other | RBL is generallya simple, inexpensive procedure. It entails a ligation of haemorrhoids using rubber bands. In RBL, a disposable suction device applies a rubber band at least 2 cm proximal to the dentate line at the base of each haemorrhoidal cushion by using an anoscope. The banding process causes necrosis of the banded tissue and slough. The resultant inflammatory reaction causes refixation of the mucosa to the underlying tissue, helping to eliminate haemorrhoidal prolapse.The end result is a return of the haemorrhoidal cushions to a more normal size and configuration, with resolution of haemorrhoidal symptoms. Receives: Procedure: RBL versus sutured mucopexy versus haemorrhoidectomy. |
| Sutured mucopexy | Other | A sutured mucopexy is an operation performed under general anaesthesia. At 4 cm proximal of the dentate line, a Z- shaped stitch through the rectal wall is placed and then at the upper level of the haemorrhoidal tissue, pulling up the prolapsing haemorrhoid high into the anal canal. Receives: Procedure: RBL versus sutured mucopexy versus haemorrhoidectomy. |
| Haemorrhoidectomy | Other | Haemorrhoidectomy involves excision of the haemorrhoidal tissue. An elliptical incision is made in the external haemorrhoidal tissue extending proximally through the dentate line to the upper limit of the haemorrhoids. The base of the haemorrhoidal complex is ligated and the haemorrhoid is excised. Receives: Procedure: RBL versus sutured mucopexy versus haemorrhoidectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
The definition of recurrent HD is: "unchanged or worse symptoms of HD compared with before starting treatment".
Measured: Assessed after 12 months post-intervention.
Patient-reported symptoms measured with the PROM-HISS
The Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS) is a newly developed questionnaire assessing the symptoms of haemorrhoidal disease over time. These are blood loss, pain, prolapse, soiling and itching. These 5 items are graded using a 5-point Likert scale, ranging from (1) 'not at all', (2) 'a little', (3) 'reasonable', (4)'a lot' and (5) 'very much'. This results in a symptom score correlating with the severity of experienced HD symptoms. The PROM-HISS will be completed by e-mail. The PROM-HISS will assess a change of the symptoms over time. ThePROM-HISS is not validated yet, but an international validation study is being developed. Hence, the scale ranges are not clear yet.
Measured: The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Secondary outcomes (10)
Early complication(s) - Abscess
Abscess will be assessed 7 days post-procedure. Abscess will be assessed by physical examination.
Measured: This outcome measure will be assessed within 7 days post-procedure.
Impact of symptoms on daily life and patient satisfaction with treatment
Assessed with the second part of the Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS), 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'. The PROM-HISS is not validated yet, but an international validation study is being developed. Hence, the scale ranges are not clear yet.
Measured: The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Health Related Quality of Life
Measured by the EQ-5D-5L questionnaire and EQ-Visual Analogue Scale. These index scores are combined with length of life to calculate the QALY.
Measured: The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Early complication(s) - Urinary retention
Urinary retention will be assessed 7 days post-procedure. It will be assessed by ultrasonography.
Measured: This outcome measure will be assessed within 7 days post-procedure.
Late complication(s) - Incontinence
The Wexner Fecal Incontinence Score will be used to assess incontinence.
Measured: Incontinence will be assessed at 52 weeks (1 year) post-procedure.
Late complication(s) - Anal stenosis
Anal stenosis will be assessed by physical examination.
Measured: Anal stenosis will be assessed at 52 weeks (1 year) post-procedure.
Late complication(s) - Fistula
Fistula will be assessed by physical examination, in case this is inconclusive, MR imaging will be performed.
Measured: Fistula will be assessed at 52 weeks (1 year) post-procedure.
Costs
Total costs over the course of 12 months will be calculated by multiplying resource use with the costs per unit. Resource use(e.g. treatment, control visits, visits to the GP, other diagnostic/medical procedures, medication) will be obtained from the CRFand from recall cost-questionnaires (e.g. over the-counter medication, and lost work days). Sources for valuation of the costs will be cost prices of the Dutch costing manual and cost prices from thePharmaco therapeutic compass. If necessary, local hospital cost prices or otherwise NZa tariffs will be used, which are largely based on integral cost prices from the Dutch hospitals. Absence of work will be calculated by using the friction cost method,which is recommended by the Dutch manual for costing (Zorginstituut Nederland, 2015).
Measured: The questionnaires will be filled out at baseline, 6 weeks and 12 months follow-up.
Cost-effectiveness
The cost-effectiveness analysis from the healthcare perspective will be based on the cumulative proportion of patients whopresent with a recurrence up to 12 months follow-up. The cost-effectiveness analysis from the societal perspective (QALYs as outcome) will be based on the EQ-5D-5L.
Measured: The EQ-5D-5L will be administered at baseline, 1 week, 6 weeks and at 12 months follow-up.
Budget Impact Analysis
A budget impact analysis (BIA) will be performed in accordance with the Dutch guidelines for economic evaluations and the ISPOR guidelines. The BIA will be performed from different perspectives (e.g. societal, healthcare) with a time horizon of 5 years. As input for the BIA, we will use the results that will become available from the clinical and cost-effectiveness study.The BIA will be performed using a simple decision analytic model. Different scenarios will be compared to investigate various levels of implementation or full substitution of any of the 3 interventions, as well as the swiftness of implementation (1-5 years). In order to test the robustness of the results, sensitivity analyses will be performed on data input and assumptions. No discounting will be performed. The target population in the BIA will be similar to the study population.
Measured: Time horizon of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective multicentre randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Stephanie Breukink, MD PhD, Study chair, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101773
- Sponsor's protocol ID
- 852002023
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet discussed with research group.
Publications
Kuiper SZ, Dirksen CD, Kimman ML, Van Kuijk SMJ, Van Tol RR, Muris JWM, Watson AJM, Maessen JMC, Melenhorst J, Breukink SO; Napoleon Trial Study Group. Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial. Contemp Clin Trials. 2020 Dec;99:106177. doi: 10.1016/j.cct.2020.106177. Epub 2020 Oct 17.
PubMed 33080380
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness and Effectiveness of Rubber Band Ligation Versus Sutured Mucopexy Versus Haemorrhoidectomy in Patients With Recurrent Haemorrhoidal Disease: a Multicentre,Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04101773
- Acronym / sponsor ID
- 852002023
- Conditions
- Hemorrhoids
- Keywords
- hemorrhoids, haemorrhoidal disease, recurrence, rubber band ligation, haemorrhoidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: There is level I evidence in literature that the first management step of HD is basic treatment, including laxatives and high fibre dieti, ii. The next treatment modality after basic treatment in case of persistent symptoms is rubber band ligation (RBL), which can be repeated if necessary.
There is currently no consensus and a lack of evidence regarding the best treatment option for these patients having recurrent HD: continuing RBL or a surgical intervention. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group.
Objective: The primary objective of this RCT is to compare the effectiveness of RBL, sutured mucopexy and haemorrhoidectomy regarding recurrence and patient-reported symptoms for recurrent grade 2 and 3 HD after at least 2 previous RBL treatments. Secondary objectives are to compare RBL, sutured mucopexy and haemorrhoidectomy for recurrent grade 2 and 3 HD after previous RBL treatments in terms of early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs and cost-effectiveness, and budget impact.
Study design: Dutch prospective multicentre randomized controlled trial.
Study population: Patients ≥18 who have recurrent grade 2 or 3 haemorrhoidal disease and who had at least 2 rubber band ligation treatments. In total, 558 patients will be included.
Intervention: Rubber band ligation versus sutured mucopexy versus haemorrhoidectomy. All three interventions are part of Dutch usual care, and serve as each other's control.
Main study parameters/endpoints: Primary outcomes are (1) recurrence and (2) patient-reported symptoms assessed after 12 months. Secondary outcome variables are early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs, cost-effectiveness and budget-impact.
Detailed description
Haemorrhoidal disease (HD) is the most common type of anorectal complaint in the Netherlands, with an annual prevalence of 10% in general practice. There is level I evidence in literature that the first management step of HD is basic treatment,including laxatives and high fibre diet. The general practitioner usually offers basic treatment. If basic treatment fails patients are referred to the hospital. About 50.000 patients are referred to a hospital for HD in the Netherlands annually. The next treatment modality after basic treatment in case of persistent symptoms is rubber band ligation (RBL), which can be repeated if necessary. RBL is an easy, cheap and outpatient-based procedure. Thirty per cent of the patients, approximately 15.000 patients a year, develop recurrent symptoms after basic treatment and repeat RBL. There is currently no consensus and a lack of evidence regarding the best treatment option for these patients having recurrent HD: continuing RBL or a surgical intervention. Literature indicates that haemorrhoidectomy is the surgical treatment of choice based on outcomes like recurrencerate. The major drawback of this technique is that it is very painful and more costly compared to RBL. A relatively novel, but regular surgical alternative is the sutured mucopexy. Although hospital costs of sutured mucopexy are comparable to haemorrhoidectomy, the operation is less painful and requires less recuperation time. The recurrence rate of sutured mucopexy is ranked between that of RBL and haemorrhoidectomy.
A Dutch national survey conducted by our research group evaluating the management practices of HD demonstrated considerable variation in the best (surgical) treatment option regarding recurrent HD, resulting in potentially undesirable practice variation. The treatment of recurrent grade 2 or 3 HD currently depends on the preference and the experience of the surgeon and of the patient, without high level evidence substantiating this practice variation. This implies a need for a high quality study regarding the treatment of recurrent grade 2 or 3 HD. Diminishing this practice variation will endorse cost-effectiveness in healthcare settings.To our knowledge, this will be the first RCT worldwide comparing RBL, sutured mucopexy and haemorrhoidectomy in recurrent grade 2 or 3 HD and generating high-level evidence of the (cost-) effectiveness. The investigators consider combining 2 trials in one with a direct comparison between these three interventions to be an efficient research approach.
Up till now, trials were mostly powered on traditional outcomes like recurrence, a definition that differs widely between studies.To improve transparency between studies and facilitate the ability to compare and combine (future) studies, our research group developed a European Society of Coloproctology (ESCP) Core Outcome Set (COS) for HD. This international COS for HD selected 'patient-reported symptoms' as primary outcome. Additionally, the investigators recently developed a patient reported symptom score for HD: the PROM-HISS. This PROM is based on most cited symptoms in literature and patient interviews. The patient advisory board (PAB) of this project underlines the clinical relevance of this PROM. As the PROM-HISS has not yet been used in other studies and has to be validated, the investigators will additionally use patient-reported symptoms assessed by the PROM-HISS, next to recurrence, as primary outcome in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective multicentre randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Rubber Band Ligation (RBL) | Other | Procedure: RBL versus sutured mucopexy versus haemorrhoidectomy.RBL is generallya simple, inexpensive procedure. It entails a ligation of haemorrhoids using rubber bands. In RBL, a disposable suction device applies a rubber band at least 2 cm proximal to the dentate line at the base of each haemorrhoidal cushion by using an anoscope. The banding process causes necrosis of the banded tissue and slough. The resultant inflammatory reaction causes refixation of the mucosa to the underlying tissue, helping to eliminate haemorrhoidal prolapse.The end result is a return of the haemorrhoidal cushions to a more normal size and configuration, with resolution of haemorrhoidal symptoms. |
| Sutured mucopexy | Other | Procedure: RBL versus sutured mucopexy versus haemorrhoidectomy.A sutured mucopexy is an operation performed under general anaesthesia. At 4 cm proximal of the dentate line, a Z- shaped stitch through the rectal wall is placed and then at the upper level of the haemorrhoidal tissue, pulling up the prolapsing haemorrhoid high into the anal canal. |
| Haemorrhoidectomy | Other | Procedure: RBL versus sutured mucopexy versus haemorrhoidectomy.Haemorrhoidectomy involves excision of the haemorrhoidal tissue. An elliptical incision is made in the external haemorrhoidal tissue extending proximally through the dentate line to the upper limit of the haemorrhoids. The base of the haemorrhoidal complex is ligated and the haemorrhoid is excised. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 years or older
- Recurrent grade 2 or 3 HD
- Patients underwent at least 2 RBL treatments in the last 3 years based on hospital electronic patient file (EPD)
- Eligible for e-mail questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
Key exclusion criteria (10 listed)
- Previous rectal or anal surgery with the exception of rubber band ligation
- Patients that have had previous surgery treatment for HD (at any time)
- Previous rectal radiation
- Pre-existing sphincter injury
- Pathologies of the colon and rectum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBL versus sutured mucopexy versus haemorrhoidectomy.All 3 interventions are part of Dutch usual care, and serve as each other's control. | Procedure or surgery | Haemorrhoidectomy, Rubber Band Ligation (RBL), Sutured mucopexy |
Primary outcome
Recurrence
Time frame: Assessed after 12 months post-intervention.
The definition of recurrent HD is: "unchanged or worse symptoms of HD compared with before starting treatment".
Patient-reported symptoms measured with the PROM-HISS
Time frame: The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
The Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS) is a newly developed questionnaire assessing the symptoms of haemorrhoidal disease over time. These are blood loss, pain, prolapse, soiling and itching. These 5 items are graded using a 5-point Likert scale, ranging from (1) 'not at all', (2) 'a little', (3) 'reasonable', (4)'a lot' and (5) 'very much'. This results in a symptom score correlating with the severity of experienced HD symptoms. The PROM-HISS will be completed by e-mail. The PROM-HISS will assess a change of the symptoms over time. ThePROM-HISS is not validated yet, but an international validation study is being developed. Hence, the scale ranges are not clear yet.
10 secondary outcomes
Early complication(s) - Abscess
Time frame: This outcome measure will be assessed within 7 days post-procedure.
Impact of symptoms on daily life and patient satisfaction with treatment
Time frame: The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Health Related Quality of Life
Time frame: The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Early complication(s) - Urinary retention
Time frame: This outcome measure will be assessed within 7 days post-procedure.
Late complication(s) - Incontinence
Time frame: Incontinence will be assessed at 52 weeks (1 year) post-procedure.
Late complication(s) - Anal stenosis
Time frame: Anal stenosis will be assessed at 52 weeks (1 year) post-procedure.
Late complication(s) - Fistula
Time frame: Fistula will be assessed at 52 weeks (1 year) post-procedure.
Costs
Time frame: The questionnaires will be filled out at baseline, 6 weeks and 12 months follow-up.
Cost-effectiveness
Time frame: The EQ-5D-5L will be administered at baseline, 1 week, 6 weeks and at 12 months follow-up.
Budget Impact Analysis
Time frame: Time horizon of 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Derived from this study: PubMed 33080380Kuiper SZ, Dirksen CD, Kimman ML, Van Kuijk SMJ, Van Tol RR, Muris JWM, Watson AJM, Maessen JMC, Melenhorst J, Breukink SO; Napoleon Trial Study Group. Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial. Contemp Clin Trials. 2020 Dec;99:106177. doi: 10.1016/j.cct.2020.106177. Epub 2020 Oct 17.
- ESCP Core Outcome Set for Haemorroidal DiseaseLink provided by the sponsor.
- ESCP Guideline for Haemorroidal DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Not yet discussed with research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Breukink, MD PhD study chair
Maastricht University Medical Centre
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RBL versus sutured mucopexy versus haemorrhoidectomy. in people with Hemorrhoids, run by Maastricht University Medical Center at 16 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Kuiper, MD (+31(0)626731279, s.kuiper@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: Assessed after 12 months post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.