Quality of life after rectal resection for cancer, with or without colostomy
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The objective is to evaluate the QoL in patients treated for rectal cancer with either APE (and permanent stoma) or LAR.
Background
Since the beginning of the last century where Miles (Miles 1908) described abdominoperineal excision (APE), this operation has been the standard treatment of choice for rectal cancer (Zaheer 1998, Koller 1998, Enker 1997). With advances in the technique for rectal anastomosis anterior resection with preservation of the sphincter function (LAR) has become the usual treatment for cancers of the upper and mid rectum. Further the advent of mechanical stapling devices has made it possible to perform anastomosis at the distal rectum and anal canal.
As the oncological results after APE and LAR are considered comparable, for the past years it has been the state of the art, that whenever feasible, rectal cancer should be treated by a sphincter‐preserving technique (Williams 1984, Wolmark 1986).
The main reason for this, has been the conviction, that the Quality of Life (QoL) for patients with a colostomy after APE was poorer, than for patients with a sphincter‐preserving technique.
However functional results after low and ultra‐low resections and anastomosis may indeed be so poor, that it also compromises the patients QoL (Ortiz 1996, Wexner 1998), and there are reports indicating that the QoL after LAR might even be poorer than after APE (CamilleriBrennan2002, Grumann 2001, CamilleriBrennan1998, Ortiz 1996, Sprangers 1995).
QoL of life is being increasingly recognised as an important outcome measure in comparing different treatment modalities for the same disease. In the future it could probably be one of the determinants in advising patients whether to perform APE or LAR (Langenhoff 2001; Anthony 2003).
Objectives
The objective is to evaluate the QoL in patients treated for rectal cancer with either APE (and permanent stoma) or LAR.
Methods
Criteria for considering studies for this review
Types of studies
All controlled clinical trials and observational controlleed studies in which QoL in patients with rectal cancer having either APE or LAR, using a multidimensional QoL instrument, will be studied. Additionally the questionnaires will have to be validated in terms of reliability (the extent to which a test effectively measures anything at all), validity (the extent to which a test measures that which it is supposed to measure) and sensitivity to change.
In addition, the following minimum standards for rating scales are set: the rating scale should either be (a) a self‐report, or (b) completed by an independent rater or relative.
Studies using questionnaires designed for a specific study without validation will not be included. Likewise studies using originally validated questionnaires, but with ad hoc changes potentially altering the original psychometric properties of the questionnaire, will not be included in the study.
Types of participants
Individuals with verified cancer of the rectum, which has been treated with either APE or LAR. There will be no discriminations concerning age, gender, race or social status.
Types of interventions
APE or LAR for rectal cancer. Quality of life assessments using validated multidimensional questionnaires. Self‐reported questionnaires filled by the patient, a relative or independent rater will be considered eligible for inclusion.
Types of outcome measures
Quality of life assessments using multidimensional questionnaires. Assessments of functional results or one‐dimensional aspects of QoL (e.g. sexual function, urinary function, pain) will not be included in the review.
Search methods for identification of studies
The literature search will be made without language restrictions and will be performed December 2002/January 2003. The search will be made in electronic databases on PubMed, Embase, LILAC, Cochrane Library, The Cochrane Colorectal Cancer Group's specialised register and by hand search in relevant literature. Abstracts books from major Gastroenterological and Colorectal congresses will be searched. Additional searches will be made via the reference lists of the selected articles.The electronic search will be made using:
PubMed:
(colorectal neoplasms OR colorect* neoplasms OR colorectal neoplasm* OR colorect* neoplasm* OR colorectal cancer OR colorect* cancer OR colorectal Canc* OR colorect* canc* OR colorectal carcinoma OR colorect* carcinoma OR colorectal carcinom* OR colorect* carcinom* OR rectal neoplasms OR rect* neoplasms OR rectal neoplasm* OR rect* neoplasm* OR rectal cancer OR rect* cancer OR rectal canc* OR rect* canc* OR rectal carcinoma OR rect* carcinoma OR rectal carcinom* OR rect* carcinom*) AND (quality of life OR qualit* of life OR quality adjusted life years OR qualit* adjusted life years OR quality adjusted life year* OR qualit* adjusted life year* OR health status OR mental health OR well‐being OR quality adjusted survival OR qualit* adjusted survival)
Cochrane Library:
#1 COLONIC‐NEOPLASMS*:ME #2 RECTAL‐NEOPLASMS*:ME #3 (#1 or #2) #4 ((((COLORECT* near CANCER) or NEOPLASM*) OR CARCINOM*) OR ADENOM*) #5 ((((COLO* near CANCER) or NEOPLASM*) OR CARCINOM*) OR ADENOM*) #6 ((((RECT* near CANCER) or NEOPLASM*) OR CARCINOM*) OR ADENOM*) #7 ((#4 or #5) or #6) #8 (#3 or #7) #9 QUALITY‐OF‐LIFE*:ME #10 (HEALTH and STATUS) #11 (MENTAL and HEALTH) #12 WELL‐BEING #13 ((QUALITY and ADJUSTED) and SURVIVAL) #14 (((QUALITY and ADJUSTED) and LIFE) and YEARS) #15 (((((#9 or #10) or #11) or #12) or #13) or #14) #16 (#8 and #15)
The Cochrane Colorectal Cancer Group's specialised register:
#1well‐being OR "quality of life" OR "mental health" OR "health status" OR "quality adjusted survival" OR "quality adjusted life years"#2"colorectal neoplasms" OR "colorectal cancer" OR " colorectal carcinoma" OR " rectal cancer" OR " rectal carcinoma"#1 AND #2
Embase:
#1 colorectal,#2 neoplasms,#3 colorectal neoplasms,#4 colorect*,#5 neoplasms, #6colorect* neoplasms,#7 colorectal,#8 neoplasm*, #9colorectal neoplasm*,#10colorect*, #11neoplasm*, #12colorect* neoplasm*,#13colorectal,#14cancer#15colorectal cancer, #16colorect*, #17cancer,#18colorect* cancer,#19colorectal,#20canc*,#21colorectal canc*,#22colorect*,#23canc*,#24colorect* canc*, #25colorectal,#26tumor,#27colorectal tumour, #28colorect*, #29tumour,#30colorect* tumour,#31rectal,#32neoplasms,#33rectal neoplasms,#34rect*,#35neoplasms,#36rect* neoplasms, #37rectal, #38neoplasm*,#39rectal neoplasm*,#40rect*,#41neoplasm*,#42rect* neoplasm*,#43rectal,#44cancer,#45rectal cancer,#46rect*,#47cancer, #48rect* cancer,#49rectal,#50canc*,#51rectal canc*,#52rect*, #53canc*,#54rect* canc*,#55rectal,#56tumor,#57rectal tumour, #58rect*,#59tumour,#60rect* tumour,#61quality, #62of, #63life, #64quality of life,#65qualit*,#66of,#67life,#68qualit* of life, #69quality,#70adjusted,#71life,#72years,#73quality adjusted life years,#74qualit*,#75adjusted,#76life,#77years, #78qualit* adjusted life years, #79quality,#80adjusted,#81life,#82year*,#83quality adjusted life year*,#84health,#85status,#86health status, #87mental, #88health,#89mental health,#90wellbeing,#91quality, #92adjusted,#93survival,#94quality adjusted survival.
(#3 or #6 or #9 or #12 or #15 or #18 or #21 or #24 or #27 or #30 or #33 or #36 or #39 or #42 or #45 or #48 or #51 or #54 or #57 or #60) and (#64 or #68 or #73 or #78 or #83 or #86 or #89 or #90 or #94)
LILACS:
Quality of life combined with colorectal cancer/colorectal neoplasms/rectal cancer/rectal neoplasms.
Data collection and analysis
One of the reviewers will check the titles and abstracts identified from the databases and hand search. A full text copy of all studies of possible relevance will obtained. The reviewer decides which studies meet the inclusion criteria.
Both reviewers will, using a data collecting form, independently extract data. Upon insufficient information the author will be contacted by e‐mail, to obtain further data.
Extracted data will be crosschecked and discrepancies resolved by consensus.
The following data will be extracted: Quality of life data, study design, level of evidence, inclusion criteria, questionnaire used, no. of patients, age, gender, tumour grade (Dukes and/or TNM), tumour distance from anal verge, level of anastomosis, formation of pouch, time since surgery, adjuvant treatment (chemo and/or radiotherapy).
Pooling of data, i.e. meta‐analysis, will only be appropriate for subjective outcomes, if there is sufficient studies that use comparable outcomes measures, i.e. questionnaires, and the studies are considered homogeneous. Comparison between generic and disease specific questionnaires and between different generic or disease specific questionnaires will not be performed. Instead a qualitative analysis will be performed.
Subgroup analysis (straight coloanal anastomosis/pouch anal anastomosis vs. APE or level of anastomosis (upper/middle/lower third of rectum vs. APE) will only be performed if sufficient data are available.
