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
Search Strategy
The following resources were searched in order to retrieve papers relating to stapled hemorrhoidopexy (SH). No language or date restrictions were applied. However, SH was introduced in 1998, therefore trials evaluating this technology would not be located prior to this date. A range of free-text terms and subject headings were used to provide a focused strategy, and a variety of search strategies were used (details of the search strategies used are presented in Appendix 10.1 of the Assessment Report [see the "Availability of Companion Documents" field]):
Databases of Systematic Reviews
Cochrane Database of Systematic Reviews (CDSR) (Cochrane Library: http://www.library.nhs.uk/)
Database of Abstracts of Reviews of Effects (DARE) (CRD Internal Database)
Health/Medical Related Databases
BIOSIS (EDINA: discontinued 31/07/06)
CENTRAL (Cochrane Central Register of Controlled Trials) (Cochrane Library: http://www.library.nhs.uk/)
Cumulative Index to Nursing and Allied Health Literature (CINAHL) (OvidWeb: http://gateway.ovid.com/athens)
EMBASE
Health Technology Assessment Database (HTA) (CRD Internal Database)
MEDLINE
MEDLINE In Process and other non-indexed citations
Science Citation Index (SCI) (Web of Knowledge: http://wos.mimas.ac.uk/)
Databases of Conference Proceedings
ISI Proceedings: science and technology (Web of Knowledge: http://wos.mimas.ac.uk/)
Zetoc Conferences (MIMAS: http://zetoc.mimas.ac.uk/)
Databases for Ongoing and Recently Completed Research
ClinicalTrials.gov (http://www.clinicaltrials.gov/)
MetaRegister of Controlled Trials (http://www.controlled-trials.com/)
National Research Register (NRR) (http://www.update-software.com/national/)
Clinical Guidelines and Systematic Reviews Resources
Clinical Evidence (BMJ Publishing Group)
Health Evidence Bulletin Wales (http://hebw.cf.ac.uk)
National Guideline Clearinghouse (http://www.guideline.gov/)
National Institute for Health and Clinical Excellence (NICE) (http://www.nice.org.uk/)
National Library for Health (NLH) Guidelines Finder (http://www.library.nhs.uk/guidelinesfinder/)
Scottish Intercollegiate Guidelines Network (SIGN) (http://www.sign.ac.uk/)
Turning Research Into Practice (TRIP+) (http://www.tripdatabase.com/index.html)
Topic Specific Websites
American Society of Colon and Rectal Surgeons (http://ascrs.affiniscape.com/index.cfm)
Association of Coloproctology of Great Britain and Ireland (http://www.acpgbi.org.uk)
Association of Surgeons of Great Britain and Ireland (http://www.asgbi.org.uk/)
Digestive Disorders Foundation (http://www.digestivedisorders.org.uk)
Hemorrhoids File (http://www.lifestages.com/health/hemorrho.html)
Inclusion and Exclusion Criteria
Two reviewers independently screened all titles and abstracts. Full paper manuscripts of any studies thought to be potentially relevant by either reviewer were obtained. The relevance of each study was assessed according to the criteria stated below. A table of retrieved studies that appeared relevant but were excluded during the screening process, is provided in Appendix 6 of the Assessment Report (see the "Availability of Companion Documents" field). Any discrepancies were resolved by consensus, or where consensus could not be reached, a third reviewer was consulted.
For any study retrieved only as an abstract, authors were contacted to request additional information. Where additional information was not obtained, abstracts were included only if sufficient outcome data were available. Studies of any language were included as long as a translator was available.
Study Designs
Randomised controlled trials (RCTs) with 20 or more participants were used to evaluate efficacy. Studies with fewer than 20 participants were excluded, as these are likely to be underpowered and of poorer quality.
Interventions and Comparators
Studies evaluating haemorrhoidopexy undertaken using a linear stapler were excluded. Studies evaluating either PPH01 or PPH03 (Endo Ethicon-Surgery [EE-S]) or Autosuture using the STRAM kit (Tyco Healthcare) were eligible for inclusion. No other staplers designed for SH were identified.
Population
Trials of people of any age with prolapsing haemorrhoids, including those with haemorrhoids that reduce spontaneously, for whom surgery is considered a relevant option were included in the review. Trials of patients undergoing emergency procedures for thrombosed haemorrhoids were excluded.
Outcomes
Outcomes were classified as peri-/post-operative (<6 weeks), short-term (>6 weeks to <12 months), 12 months, and long-term (>12 months). Where studies reported continuous outcomes as medians and ranges, authors were contacted for mean and standard deviation (SD). Overall patient satisfaction, indicating a preference for one or other technique or no preference, was extracted at each time point if reported. A full list of outcomes extracted at each time point is provided in Appendix 10.2 of the Assessment Report (see the "Availability of Companion Documents" field).
Refer to Section 5.1.2 of the Assessment Report for more information on inclusion and exclusion criteria.
Cost-Effectiveness
Systematic Review of Existing Cost-Effectiveness Evidence
To review the existing cost-effectiveness evidence base, papers obtained during the clinical effectiveness review were searched to check whether they included cost-effectiveness data. In addition, four economics databases were searched to identify additional economic evaluations (refer to Appendix 10.1.2 of the Assessment Report [see the "Availability of Companion Documents" field]).
To obtain data to populate parameters of the York economic model, a series of specific searches were undertaken. These included searches for relevant data on health related quality of life (HRQoL), the incidence and prevalence of haemorrhoids, RCTs evaluating open versus closed haemorrhoidectomy, cohort studies of complications and symptoms associated with haemorrhoidal surgery and the length of hospital stay following haemorrhoidal surgery as reported in Appendix 10.1.3 of the Assessment Report (see the "Availability of Companion Documents" field).
In terms of the inclusion criteria, a broad range of studies was considered in the assessment of cost-effectiveness, including economic evaluations conducted alongside trials, modelling studies and analyses of administrative databases. Any duplicate references that were obtained were taken out and the remaining references were checked for relevance by a health economist. Studies were included in the cost-effectiveness review if they considered the costs and outcomes associated with two or more surgical procedures in the treatment of haemorrhoids. Therefore, studies based on cost-consequence analysis, cost-utility analysis, cost-effectiveness analysis, cost-minimisation and cost-benefit analysis, were eligible for inclusion.