• National Institute for Health and Clinical Excellence (NICE). Stapled haemorrhoidopexy for the treatment of haemorrhoids. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Sep. 25 p. (Technology appraisal guidance; no. 128).

This is the current release of the guideline.

Hemorrhoids

Assessment of Therapeutic Effectiveness
Management

Colon and Rectal Surgery
Internal Medicine

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

To evaluate the clinical effectiveness and cost-effectiveness of stapled hemorrhoidopexy for the treatment of hemorrhoids

Patients with hemorrhoids

Stapled hemorrhoidopexy using the HCS33 circular stapler

• Clinical effectiveness
  • Pain
  • Bleeding
  • Residual prolapse
  • Operating time
  • Duration of hospital stay
  • Wound healing
  • Time to first bowel movement
  • Complications
  • Need for further intervention
  • Incontinence
  • Quality of life
• Cost-effectiveness

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Clinical Effectiveness

The electronic and hand searches retrieved 653 references. Of these, 147 full papers considered potentially relevant to the review of clinical effectiveness were retrieved and screened for relevance. Twenty seven randomised controlled trials (RCTs) reported in 35 publications, met the inclusion criteria.

Cost-Effectiveness

No formal full economic evaluations assessing the cost-effectiveness of stapled hemorrhoidopexy (SH) for the treatment of haemorrhoids were found in the published literature. One study examined the costs associated with surgical procedures for haemorrhoids in some detail.

Endo Ethicon-Surgery (EE-S) submitted an economic model.

Expert Consensus

Not applicable

Meta-Analysis
Review of Published Meta-Analyses
Systematic Review with Evidence Tables

Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Clinical Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report. The assessment report for this technology appraisal was prepared by the Centre for Reviews and Dissemination (CRD) and the Centre for Health Economics (CHE) Technology Assessment Group, University of York (see the "Availability of Companion Documents" field).

Clinical Effectiveness

Data Extraction Strategy

All data relating to both study design and quality were extracted by one reviewer and independently checked for accuracy by a second. Disagreements were resolved through consensus, or where consensus could not be reached, a third reviewer was consulted. Foreign language studies were extracted by one reviewer along with a native speaker of that language. Where multiple publications of the same study were identified, data were extracted and reported as a single study. A list of the type of data extracted at each time point is provided in Appendix 10.2 of the Assessment Report (see the "Availability of Companion Documents" field).

Quality Assessment Strategy

The quality of the individual studies was assessed by one reviewer and independently checked by a second. Disagreements were resolved through consensus, or where consensus could not be reached, a third reviewer was consulted. The quality of randomised controlled trials (RCTs) was assessed using standard checklists adapted to incorporate topic-specific quality issues. The checklist is provided in Appendix 10.3 of the Assessment Report, together with the guidelines used to score each criterion.

Data Analysis

Odd ratios (OR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. Mean differences and 95% CI were calculated for continuous outcomes. Data are reported separately for each outcome measure. All meta-analyses were conducted in RevMan 4.2.9 (Cochrane Collaboration). Pooled OR and 95% confidence intervals (CI) were calculated for dichotomous outcomes, and weighted mean differences (WMD) and 95% CI for continuous outcomes.

Studies were pooled in primary analyses if there was no statistically significant heterogeneity between studies. A random effects model was used, unless there were three or less studies included in the analysis, in which case a fixed effect model was used. Sources of heterogeneity, such as patient population and quality criteria were investigated by visual inspection of the forest plots and explored further using sensitivity analyses. Possible effects of study quality on the effectiveness data and review findings are discussed. For the primary outcomes (pain, prolapse, bleeding) sensitivity analyses were conducted to explore the impact of the high losses to follow-up. For both primary and secondary outcomes, sensitivity analyses were conducted to explore the impact of outlying results.

The relationship between visual analogue scale (VAS) pain score, days from primary surgery and treatment was explored further using Bayesian meta-regression (refer to Appendix 10.4 of the Assessment Report).

Refer to Section 5.1.5 of the Assessment Report (see the "Availability of Companion Documents" field) for more information.

Cost-Effectiveness

A data extraction form for use in previous Technology Assessment Reviews was used to abstract data on all economic evaluations reviewed. The quality of the cost-effectiveness studies was assessed based on a checklist updated from that developed by Drummond et al, Drummond M, Sculpher M, Torrance G, O'Brien B, Stoddart G. Methods for the economic evaluation of health care programmes. 3rd ed. Oxford: Oxford University Press, 2005) and which reflects the criteria for economic evaluation detailed in the methodological guidance developed by NICE (Refer to Appendices 10.3 and 10.5.2 of the Assessment Report [see the "Availability of Companion Documents" field). In addition, Endo Ethicon-Surgery (EE-S) (Johnson and Johnson) submitted an economic model.

Expert Consensus

Considerations

Technology appraisal recommendations are based on a review of clinical and economic evidence.

Technology Appraisal Process

The National Institute for Health and Clinical Excellence (NICE) invites 'consultee' and 'commentator' organisations to take part in the appraisal process. Consultee organisations include national groups representing patients and carers, the bodies representing health professionals, and the manufacturers of the technology under review. Consultees are invited to submit evidence during the appraisal and to comment on the appraisal documents.

Commentator organisations include manufacturers of the products with which the technology is being compared, the National Health Service (NHS) Quality Improvement Scotland and research groups working in the area. They can comment on the evidence and other documents but are not asked to submit evidence themselves.

NICE then commissions an independent academic centre to review published evidence on the technology and prepare an 'assessment report'. Consultees and commentators are invited to comment on the report. The assessment report and the comments on it are then drawn together in a document called the evaluation report.

An independent Appraisal Committee then considers the evaluation report. It holds a meeting where it hears direct, spoken evidence from nominated clinical experts, patients and carers. The Committee uses all the evidence to make its first recommendations, in a document called the 'appraisal consultation document' (ACD). NICE sends all the consultees and commentators a copy of this document and posts it on the NICE website. Further comments are invited from everyone taking part.

When the Committee meets again it considers any comments submitted on the ACD; then it prepares its final recommendations in a document called the 'final appraisal determination' (FAD). This is submitted to NICE for approval.

Consultees have a chance to appeal against the final recommendations in the FAD. If there are no appeals, the final recommendations become the basis of the guidance that NICE issues.

Who is on the Appraisal Committee?

NICE technology appraisal recommendations are prepared by an independent committee. This includes health professionals working in the NHS and people who are familiar with the issues affecting patients and carers. Although the Appraisal Committee seeks the views of organisations representing health professionals, patients, carers, manufacturers and government, its advice is independent of any vested interests.

Not applicable

No published economic evaluations were identified by Ethicon Endo-Surgery or the Assessment Group.

Ethicon Endo-Surgery submitted a cost–utility analysis comparing stapled haemorrhoidopexy with Milligan-Morgan haemorrhoidectomy, using a cohort-based probabilistic model. This model included people with third- and fourth-degree haemorrhoids, and the analysis was based on the following health states: full recovery without recurrent prolapse, recurrent prolapse that can be self-treated and recurrent prolapse requiring re-surgery (the latter of which may be followed by no further prolapse or a second recurrent prolapse). Complications or symptoms other than prolapse were not included. The average time from initial surgery to recurrence of prolapse was assumed to be 120 days and the waiting time from recurrence with severe symptoms to re-intervention was assumed to be 10 days. The model followed a 1-year time horizon and it was assumed that there was no difference in treatment effect beyond 12 months. The economic evaluation was undertaken from a UK National Health Service (NHS) perspective. Because there were no randomised controlled trials (RCTs) that recorded utility in the crucial early postoperative period, utility weights were estimated indirectly by converting Visual Analogue Scale (VAS) pain scores from one RCT and matching short form (SF)-36 health survey dimensions to utility using a cross-sectional dataset of people aged 39 to 67 who were registered with a general practitioner in Sheffield. The SF-36 data were then converted into utility values.

The Ethicon Endo-Surgery base-case resulted in an incremental cost of 191 pounds sterling and 0.009 incremental quality adjusted life years (QALY) for stapled haemorrhoidopexy compared with conventional haemorrhoidectomy, with an incremental cost-effectiveness ratio (ICER) of 22,416 pounds sterling per QALY. At a willingness to pay of 30,000 pounds sterling per QALY there was a greater than 70% probability that stapled haemorrhoidopexy was cost effective.

The Assessment Group undertook a cost–utility analysis comparing stapled haemorrhoidopexy with conventional haemorrhoidectomy. The structure of the Assessment Group's model was broadly similar to the Ethicon Endo-Surgery model, but it included a wider definition of symptoms, complications of surgery and both surgical and non-surgical re-interventions, and it considered a 3-year time horizon. As in the Ethicon Endo-Surgery model, utility weights were estimated indirectly. This was done by converting VAS pain scores from ten RCTs to SF-36 data. The SF-36 data were then converted into utility values, but using a different methodology from that used by the manufacturer. The Assessment Group used the pain dimension of the SF-36 to calculate utility values, but the manufacturer included pain and physical functioning SF-36 dimensions. The difference between the utility with stapled haemorrhoidopexy and conventional haemorrhoidectomy was smaller in the Assessment Group's model than in the Ethicon Endo-Surgery model.

The Assessment Group's base-case resulted in an incremental cost of 19 pounds sterling and 0.001 fewer QALYs for stapled haemorrhoidopexy compared with conventional haemorrhoidectomy over 3 years. Stapled haemorrhoidopexy was therefore dominated by conventional haemorrhoidectomy. In the range of willingness to pay of 20,000 pounds sterling to 30,000 pounds sterling per QALY there was a 45% probability that stapled haemorrhoidopexy was cost effective.

The Assessment Group carried out a number of one-way sensitivity analyses using both its own model and the Ethicon Endo-Surgery model, and found that the ICER was extremely sensitive to the assumptions used, with very small differences in the benefits resulting in large differences in the ICERs. Only when the Assessment Group's model was run with the Ethicon Endo-Surgery utility values was an ICER of less than 30,000 pounds sterling per QALY produced. Alternatively, when the Ethicon Endo-Surgery model was run with the Assessment Group's utility values, this gave an ICER of 383,985 pounds sterling. When the price of the device was set at the 2006 price of 420 pounds sterling rather than the estimated 2007 price of 437 pounds sterling, the total cost difference in the Assessment Group's model decreased to approximately 2 pounds sterling.

External Peer Review

Consultee organizations from the following groups were invited to comment on the draft scope, Assessment Report and the Appraisal Consultation Document (ACD) and were provided with the opportunity to appeal against the Final Appraisal Determination.

• Manufacturer/sponsors
• Professional/specialist and patient/carer groups
• Commentator organisations (without the right of appeal)

In addition, individuals selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups were also invited to comment on the ACD.

This technology appraisal examined the currently available devices for stapled haemorrhoidopexy. The evidence considered refers to the HCS33 circular stapler (models PPH01 and PPH03, Ethicon Endo-Surgery). At the time of the technology appraisal, there was no evidence to make recommendations for the Autosuture stapler with the STRAM kit adaptor.

• Stapled haemorrhoidopexy, using a circular stapler specifically developed for haemorrhoidopexy, is recommended as an option for people in whom surgical intervention is considered appropriate for the treatment of prolapsed internal haemorrhoids.

None provided

The type of evidence supporting the recommendations is not specifically stated.

Appropriate use of stapled haemorrhoidopexy in the treatment of haemorrhoids

The short-term complications of stapled haemorrhoidopexy include pain, urinary retention, bleeding, and perianal sepsis. Long-term complications may include anal fissure, anal stenosis, incontinence, fistula, and the recurrence of hemorrhoidal symptoms.

This guidance represents the view of the Institute, which was arrived at after careful consideration of the available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

Getting Better

Effectiveness

• National Institute for Health and Clinical Excellence (NICE). Stapled haemorrhoidopexy for the treatment of haemorrhoids. London (UK): National Institute for Health and Clinical Excellence (NICE); 2007 Sep. 25 p. (Technology appraisal guidance; no. 128).

Not applicable: The guideline was not adapted from another source.

2007 Sep

National Institute for Health and Clinical Excellence (NICE) - National Government Agency [Non-U.S.]

National Institute for Health and Clinical Excellence (NICE)

Appraisal Committee

Committee Members: Professor Keith Abrams, Professor of Medical Statistics, University of Leicester; Dr Jeff Aronson, Reader in Clinical Pharmacology, University of Oxford; Dr Darren Ashcroft, Senior Clinical Lecturer, School of Pharmacy and Pharmaceutical Sciences, University of Manchester; Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester; Dr Peter Barry, Consultant in Paediatric Intensive Care, Leicester Royal Infirmary; Professor Stirling Bryan, Director of the Health Economics Facility, University of Birmingham; Professor John Cairns, Public Health and Policy, London School of Hygiene and Tropical Medicine; Dr Mark Charkravarty, Head of Government Affairs and NHS Policy, Procter and Gamble Pharmaceuticals (UK) Ltd; Professor Jack Dowie, Health Economist, London School of Hygiene and Tropical Medicine; Lynn Field, Nurse Director, Pan Birmingham Cancer Network; Professor Christopher Fowler, Professor of Surgical Education, University of London; Dr Fergus Gleeson, Consultant Radiologist, Churchill Hospital; Ms Sally Gooch, Former Director of Nursing and Workforce Development, Mid Essex Hospitals Services NHS Trust; Mrs Barbara Greggains, Lay member; Mr Sanjay Gupta, Former Stroke Services Manager, Basildon and Thurrock Universities Hospitals NHS Trust; Dr Mike Laker, Medical Director, Newcastle Hospitals NHS Trust; Mr Terence Lewis, Mental Health Consultant, National Institute for Mental Health in England; Professor Gary McVeigh, Professor of Cardiovascular Medicine, Queens University, Belfast; Dr Ruairidh Milne, Senior Lecturer in Health Technology Assessment, National Coordinating Centre for Health Technology; Dr Neil Milner, General Medical Practitioner, Tramways Medical Centre, Sheffield; Dr Rubin Minhas, General Practitioner, CHD Clinical Lead, Medway PCT; Dr John Pounsford, Consultant Physician, North Bristol NHS Trust; Dr Rosalind Ramsay, Consultant Psychiatrist, Adult Mental Health Services, Maudsley Hospital; Dr Christa Roberts, UK Country Manager, Abbott Vascular; Dr Stephen Saltissi, Consultant Cardiologist, Royal Liverpool University Hospital; Dr Lindsay Smith, General Practitioner, East Somerset Research Consortium; Mr Roderick Smith, Director of Finance, West Kent Primary Care Trust; Mr Cliff Snelling, Lay member; Dr Ken Stein, Senior Lecturer, Peninsula Technology Assessment Group (PenTAG), University of Exeter; Professor Andrew Stevens, Professor of Public Health, University of Birmingham; Dr Rod Taylor, Associate Professor in Health Services Research, Peninsula Medical School, Universities of Exeter and Plymouth

Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal.

This is the current release of the guideline.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.