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 Aberdeen Health Technology Assessment Group (Health Services Research Unit, and Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen) (See the "Availability of Companion Documents" field.)
Clinical Effectiveness
Search Strategy
Electronic searches were undertaken to identify published and unpublished reports of randomized controlled trials (RCTs) and systematic reviews evaluating the effectiveness of laparoscopic and hand-assisted laparoscopic (HAL) surgery for colorectal cancer. Searches were restricted to the years 2000 onwards without language restriction and included abstracts from recent conference proceedings.
The main databases searched were: Medline (2000 to May Week1 2005), Excerpta Medica Database (EMBASE) (2000 to Week 19 2005), Biosciences Information Service (BIOSIS) (2000 to May 2005), Science Citation Index (2000 to 27th May 2005), Medline Extra (11th May 2005), Cochrane Controlled Trials Register (The Cochrane Library, Issue 2 2005), Cochrane Database of Systematic Reviews (The Cochrane Library, Issue 2,2005), Database of Abstracts of Reviews of Effectiveness (May 2005), HTA Database (May 2005), Health Management Information Consortium (2000 to May 2005) and Journals @ Ovid Full Text (2000 to July 2005 for selected surgical journals). In addition, recent conference proceedings and reference lists of all included studies were scanned to identify additional potentially relevant studies. Full details of the search strategies used are documented in Appendix 1 of the Assessment Report (see the "Availability of Companion Documents" field).
All titles and abstracts identified in these ways were assessed to identify potentially eligible studies. Two reviewers independently assessed them for inclusion, using a study eligibility form developed for this purpose (see Appendix 2 of the Assessment Report [see the "Availability of Companion Documents" field). Any disagreements were resolved by consensus or arbitration. Systematic reviews were used to identify pre-2000 RCTs but were not included in this review. Lead authors of all included RCTs were contacted directly to identify further studies and unpublished data.
Inclusion and Exclusion Criteria
Types of Studies
The Assessment Group included individual RCTs and individual patient data meta-analyses of RCTs of laparoscopic surgery, laparoscopic-assisted surgery, and hand-assisted laparoscopic surgery (HALS) compared to open surgery for colorectal cancer. United Kingdom (UK) registries, providing data for a minimum of three years follow-up for any of the surgical techniques either alone or in comparison with each other, were also included. Studies were eligible irrespective of the language in which they were reported. Initially, the Assessment Group had intended to include cohort studies with a minimum follow-up of three years, but in the event they decided that this was not necessary as the length of follow-up available from RCTs (and particularly an individual patient data meta-analysis of RCTs) was considered sufficient to provide long-term data that were more robust than data from nonrandomized cohort studies.
Types of Participants
Studies of adults with colorectal cancer who have undergone surgery were included. Patients undergoing palliative treatment (non-curative surgery) were excluded. In addition, the following subgroups were considered: location of cancer; stage of cancer; and mean age at diagnosis.
Types of Outcomes
Short-term and long-term measures of outcomes were sought. See the "Major Outcomes Considered" field.
Data Extraction Strategy
The titles and abstracts of all papers identified by the search strategy were screened. Full text copies of all potentially relevant studies were obtained and two reviewers independently assessed them for inclusion. Reviewers were not blinded to the names of studies' authors, institutions, or sources of the reports. Any disagreements were resolved by consensus or arbitration.
A data extraction form was developed to record details of trial methods, participants, interventions, patient characteristics and outcomes (see Appendix 3 of the assessment report [see the "Companion Documents" field). Two reviewers independently extracted data from the included studies. Any differences that could not be resolved through discussion were referred to an arbiter.
Cost Effectiveness
Search Strategies
Studies that reported both costs and outcomes of laparoscopic and/or hand-assisted laparoscopic surgery techniques compared to open surgery for the treatment of colorectal cancer were sought from the systematic review of the literature. No language restrictions were imposed but as this review is an update of an earlier review conducted in 2000, the searching was limited to studies published between 2000 to 2005.
Databases searched were Medline (2000 to May Week 2 2005), Embase (2000 to Week 21 2005), Medline Extra (23rd May 2005), Science Citation Index (2000 to 27th May 2005), National Health Service Economic Evaluation Database (NHS EED), (May 2005), HTA Database (May 2005), Health Management Information Consortium (2000 to May 2005) and Journals @ Ovid Full Text (2000 to July 2005 for selected surgical journals). In addition, recent conference proceedings and reference lists of all included studies were scanned to identify additional potentially relevant studies. Other sources of information consulted included: references in relevant articles; selected experts in the field; references of consultees' submissions. Full details of the search strategies used are documented in Appendix 1 of the Assessment Report (see the "Companion Documents" field).
Inclusion and Exclusion Criteria
To be included, studies had to compare, in terms of both costs and outcomes, strategies involving laparoscopic and/or hand-assisted laparoscopic surgery compared to open surgery for treatment of colorectal cancer. Studies were included even if they made no formal attempt to relate cost to outcome data in a cost-effectiveness or cost-utility analysis. One reviewer assessed all abstracts for relevance and full papers were obtained for those that appeared potentially relevant.
Data Extraction Strategy
See section 4.1.3 of the Assessment Report (see "Availability of Companion Documents" field) for a list of the data extracted from each included primary study.