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Treatment for early rectal cancer
Evidence review C1
NICE Guideline, No. 151
National Guideline Alliance (UK).
Treatment for early rectal cancer
This evidence review supports recommendations 1.3.1 to 1.3.2.
Review question
What is the most effective treatment for early rectal cancer?
Introduction
Early rectal cancer is defined as a TNM classification of T1 or T2, N0 and M0 (National Comprehensive Cancer Network 2010). Currently, there is wide variation in practice in treatments for early rectal cancer. While treatment for early rectal cancer has typically involved anterior or abdominoperineal resection, local excision treatments have been shown to be promising for some cases of early rectal cancer (Park 2012). Minimally invasive procedures such as local excision may prevent the potential morbidity and mortality of more invasive procedures, and also result in improved rates of quality of life (Park 2012). Therefore, the aim of this review was to determine the most effective treatment for early rectal cancer.
Summary of the protocol
Please see Table 1 for a summary of the population, intervention, comparison and outcomes (PICO) characteristics of this review.
Table 1
Summary of the protocol (PICO table).
For further details see the review protocol in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual 2014. Methods specific to this review question are described in the review protocol in appendix A.
Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).
Clinical evidence
Included studies
Nine publications from 4 RCTs and 5 retrospective cohort studies were included in this review (Barendse 2018; Chakravarti 1999; Chen 2012; Kawaguti 2014; Kiriyami 2011; Lezoche 2012; Park 2013; Winde 1997; Yan 2013).
The included studies are summarised in Table 2.
Three RCTs (Chen 2012; Lezoche 2012; Winde 1997) compared total mesorectal excision to transanal excision. One cohort study compared endoscopic resection to transanal excision (Chakravarti 1999). Four cohort studies compared transanal excision with external radiotherapy or chemoradiotherapy to transanal excision alone (Kawaguti 2014; Kiriyami 2011; Park 2013; Yan 2013).
See the literature search strategy in appendix B and study selection flow chart in appendix C.
Excluded studies
Studies not included in this review with reasons for their exclusions are provided in appendix K.
Summary of clinical studies included in the evidence review
A summary of the studies that were included in this review are presented in Table 2.
Table 2
Summary of included studies.
See the full evidence tables in appendix D and the forest plots in appendix E.
Quality assessment of clinical outcomes included in the evidence review
See the clinical evidence profiles in appendix F.
Economic evidence
Included studies
A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.
Excluded studies
A global search of economic evidence was undertaken for all review questions in this guideline. See Supplement 2 for further information.
Economic model
No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.
Evidence statements
Clinical evidence statements
Comparison 1: Total mesorectal excision versus transanal excision
Critical outcomes
Overall survival
- Low quality evidence from 2 RCTs (N=153; median follow-up 3.6 to 9.6 years) showed no clinically important difference in overall survival between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
- Low quality evidence from 1 RCT (N=60; median follow-up 18 months) reports no deaths in either arm when comparing total mesorectal excision to transanal excision in people with early rectal cancer.
Local recurrence
- Low quality evidence from 1 RCT (N=60; median follow-up 1.5 years) showed no clinically important difference in local recurrence free survival between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 2 RCTs (N=153; mean/median follow-up 3.6 to 9.6 years) showed no clinically important difference in local recurrence rate between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
Overall quality of life
No evidence was identified to inform this outcome.
Important outcomes
Disease-free survival
- Low quality evidence from 1 RCT (N=100; median follow-up 9.6 years) showed no clinically important difference in disease-free survival between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
Mortality (within 90 days)
- Low quality evidence from 1 RCT (N=100) showed no clinically important difference in mortality (within 30 day timeframe) between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
Grade 3 or 4 treatment complications
- Low quality evidence from 1 RCT (N=100) showed no clinically important difference in perianal phlegmon or pelvic perionitis between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
- Low quality evidence from 1 RCT (N=60) showed no clinically important difference in rectal perforation between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
- Low quality evidence from 1 RCT (N=53) showed no clinically important difference in peritoneal perforation between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
- Low quality evidence from 1 RCT (N=60) showed no clinically important difference in major bleeding (> 200 mL) between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
- Low quality evidence from 1 RCT (N=53) showed no clinically important difference in ischemic compartment syndrome of the lower leg between receiving total mesorectal excision compared to transanal excision in people with early rectal cancer.
Comparison 2: Endoscopic resection versus transanal excision
Critical outcomes
Overall survival
- There were no events in 1 RCT (N=176; follow-up >4 years [mean/median follow-up not reported]); quality of evidence and relative effect were not estimable.
- There were no events in 1 cohort study (N=24; median follow-up 5 years); quality of evidence and relative effect were not estimable.
- There were no events in 1 cohort study (N=63; median follow-up 1.6 to 2.4 years); quality of evidence and relative effect were not estimable.
- There were no events in 1 cohort study (N=63; median follow-up 1.7 to 2.3 years); quality of evidence and relative effect were not estimable.
- There were no events in 1 cohort study (N=54; median follow-up 1.3 to 2.3 years); quality of evidence and relative effect were not estimable.
Local recurrence
- Low quality evidence from 1 RCT (N=176; mean/median follow-up not reported) showed no clinically important difference in local recurrence rates between endoscopic resection compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 1 cohort study (N=24; median follow-up 5 years) showed no clinically important difference in local recurrence rates between endoscopic resection compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 1 cohort study (N=63; median follow-up 4.6 years) showed a clinically important decrease in local recurrence rates between endoscopic resection compared to transanal excision in people with early rectal cancer.
- There were no events in 1 cohort study (N=63; median follow-up 1.7 to 2.3 years); quality of evidence and relative effect were not estimable.
- There were no events in 1 cohort study (N=54; median follow-up 1.3 to 2.3 years); quality of evidence and relative effect were not estimable.
Overall quality of life
No evidence was identified to inform this outcome.
Important outcomes
Disease-free survival
No evidence was identified to inform this outcome.
Mortality (within 90 days)
No evidence was identified to inform this outcome.
Grade 3 or 4 treatment complications
- Very low quality evidence from 1 cohort study (N=24) showed no clinically important difference in pneumothorax between endoscopic resection compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 1 cohort study (N=54) showed no clinically important difference in rectal perforation between endoscopic resection compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 1 cohort study (N=24) showed no clinically important difference in peritoneal perforation between endoscopic resection compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 1 cohort study (N=24) showed no clinically important difference in pneumoperitoneum between endoscopic resection compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 1 cohort study (N=63) showed no clinically important difference in pneumoperitoneum between endoscopic resection compared to transanal excision in people with early rectal cancer.
- Very low quality evidence from 1 cohort study (N=63) showed no clinically important difference in perforation/postoperative leakage between endoscopic resection compared to transanal excision in people with early rectal cancer.
Comparison 3: Transanal excision with external radiotherapy or chemoradiotherapy versus transanal excision alone
Critical outcomes
Overall survival
No evidence was identified to inform this outcome.
Local recurrence
- Very low quality evidence from 1 cohort study (N=99; median follow-up 4.3 years) showed no clinically important difference in local recurrence free survival between receiving transanal excision with external radiotherapy or chemoradiotherapy compared to transanal excision alone in people with early rectal cancer.
Overall quality of life
No evidence was identified to inform this outcome.
Important outcomes
Disease-free survival
No evidence was identified to inform this outcome.
Mortality (within 90 days)
No evidence was identified to inform this outcome.
Grade 3 or 4 complications
No evidence was identified to inform this outcome.
Comparison 4: Internal radiotherapy versus transanal excision
No evidence was identified to inform this comparison.
Comparison 5: Total mesorectal excision versus endoscopic resection
No evidence was identified to inform this comparison.
Comparison 6: Total mesorectal excision versus internal radiotherapy
No evidence was identified to inform this comparison.
Comparison 7: Endoscopic resection versus external radiotherapy or chemoradiotherapy with or without surgery
No evidence was identified to inform this comparison.
Comparison 8: Endoscopic resection versus internal radiotherapy
No evidence was identified to inform this comparison.
Comparison 9: Total mesorectal excision versus internal radiotherapy
No evidence was identified to inform this comparison.
Comparison 10: External radiotherapy or chemoradiotherapy with or without surgery versus internal radiotherapy
No evidence was identified to inform this comparison.
Economic evidence statements
No economic evidence was identified which was applicable to this review question.
The committee’s discussion of the evidence
Interpreting the evidence
The outcomes that matter most
Overall survival and local recurrence were considered critical outcomes for decision making because local recurrence suggests ineffective treatment of the early rectal cancer, potentially requiring further treatment and affecting overall survival. Overall quality of life was also a critical outcome because of the impact of disease recurrence on patients and the potential long term adverse effects of the treatments considered.
Disease-free survival and treatment complications were considered important outcomes.
The quality of the evidence
Evidence was available for the comparison of total mesorectal excision versus transanal excision, endoscopic resection versus transanal excision, transanal excision versus external radiotherapy or chemoradiotherapy. No evidence was found comparing internal radiotherapy versus transanal excision, total mesorectal excision versus endoscopic resection, total mesorectal excision versus internal radiotherapy, endoscopic resection versus external radiotherapy or chemoradiotherapy with or without surgery, endoscopic resection versus internal radiotherapy, total mesorectal excision versus internal radiotherapy, or external radiotherapy or chemoradiotherapy with or without surgery versus internal radiotherapy. A network meta-analysis was considered but was not possible due to the limited available evidence and the limitations in the evidence discussed below.
Evidence was available for all of the outcomes except quality of life. The quality of the evidence was assessed using GRADE and varied from low to very low quality. The quality of evidence was most often downgraded because of methodological limitations affecting the risk of bias, indirectness of the study population, and imprecision around the risk estimate.
Methodological limitations affecting the risk of bias were generally attributable to lack of or unclear randomisation, allocation and outcome assessment blinding, and lack of controlling for confounders. Indirectness of the study population was attributable to a proportion of the sample having lymphatic involvement at baseline. Uncertainty around the risk estimate was generally attributable to low event rates and small sample sizes.
The largest of the included RCTs was a non-inferiority trial and not powered to determine the most effective treatment. Given that, even when pooled together, the remaining studies had much smaller sample sizes than this trial, the committee was unable to conclude with confidence whether one treatment was better than the other.
The quality of the evidence for some of the outcomes was not assessable due to the data being presented as medians or zero events in both treatment arms.
The low quality of the evidence, and lack of evidence for many comparisons, affected the decision-making and the strength of the recommendations as there was insufficient evidence to recommend one type of treatment over another.
Benefits and harms
While the evidence did not favour one treatment over the other, the committee were aware of risks and benefits of each approach.
TAE, including transanal minimally invasive surgery (TAMIS) and transanal endoscopic microsurgery (TEMS), needs a general anaesthetic, may require conversion to an open or laparoscopic procedure and may have postoperative complications. However, benefits include it being a minimally invasive procedure (no external scars) requiring no resection of the bowel, and therefore better functional results, shorter hospital stay and the avoidance of a stoma. It also allows for a full thickness excision of the lesion.
ESD may need further surgery depending on histology and prevents a full thickness excision. However, benefits include the fact that it is a minimally invasive procedure that can be performed with sedation instead of general anaesthesia, does not require the resection of the bowel and therefore has better functional results, has shorter hospital stays (can be performed as a day case) and avoids the need for a stoma.
TME may require conversion to an open procedure, have significant postoperative complications, including anastomotic leak, pelvic abscess, anastomotic stricture and bleeding, injury to neighbouring structures, require a potentially permanent stoma, lead to incisional hernia, adhesions, sexual and bowel dysfunction and require a longer hospital stay. However, while TME is associated with higher morbidity, it can give better curative results as it also removes lymph nodes which allows for accurate staging of the cancer and whether adjuvant treatment is required. Furthermore TME can be done with a minimally invasive technique (laparoscopic or robotic).
The committee highlighted that the key point on deciding which technique to use is the risk of residual disease, specifically, lymph node involvement. A local excision (TAE and ESD) will not remove the lymph nodes whereas a TME does. Furthermore, until the lesion is resected, staging is based on radiological investigations. From their clinical experience, the committee noted that most patients would favour a local excision over a TME. However, if histological features of the local excision specimen determine a high risk of nodal disease, then a TME procedure would subsequently be recommended. Additionally, TME may be discussed from the outset if initial staging scans indicate the need for a more invasive procedure or the patient indicates interest for a single, definitive procedure.
The committee considered that a potential benefit of the recommendations could be the increased use of TEM or ESD, with fewer treatment-related adverse events than TME. Potential risks include over-treatment with TME, or radiotherapy, and contention over the effectiveness of treatments. The committee balanced these harms against the benefits by recommending a discussion of the likely implications of treatments to help patients bring their own values and preferences into the treatment decision. Because the evidence did not favour one treatment option over another one, a shared decision about which treatment to have should be based on the person’s preferences, taking into consideration the implications of each of these treatments, including potential benefits, risks and practical factors.
No evidence was available on the effectiveness of preoperative radiotherapy for people with early rectal cancer. Based on the committee’s expertise, they made a consensus recommendation about not offering preoperative radiotherapy for these people unless in a context of a clinical trial. The committee was aware of the ongoing STAR-TREC trial comparing total mesorectal excision to either long-course or shortcourse chemoradiotherapy.
Cost effectiveness and resource use
A systematic review of the economic literature was conducted but no relevant studies were identified which were applicable to this review question.
The recommendations partly reflect current practice as the three options that have been recommended (ESD, TAE [including TAMIS and TEMS] and TME) are the treatments that are most frequently used. However, while the recommendation does not suggest a preference for one technique other another, it is possible that it may result in the increased use of ESD. An increase in resources may be required to provide ESD in centres where it is not currently available. This could include the cost of training staff as well as the equipment costs. However, it’s unlikely to require a substantial increase in resources as many centres are likely to continue using other techniques.
Other factors the committee took into account
No areas of the review or recommendations need specific attention with regard to equalities issues.
Given the low quality of the published evidence the committee discussed making research recommendations about the effects of interventions for early rectal cancer on patient-reported quality of life and about how interventions could be selected for patients. Following their discussion the committee decided not to make any research recommendations for this topic, partly because it was not a priority in comparison to the other research topics within this guideline and also because the some of the interventions of interest were already being compared in the ongoing STAR-TREC trial.
References
Barendse 2018
Barendse R, Musters G, de Graaf E, et al. (2018) Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study). Gut 67(5): 837–846 [PubMed: 28659349]Chakravarti 1999
Chakravarti A, Compton C, Shellito P, et al. (1999) Long-term follow-up of patients with rectal cancer managed by local excision with and without adjuvant irradiation. Annals of Surgery 230(1): 49–54 [PMC free article: PMC1420844] [PubMed: 10400036]Chen 2013
Chen Y, Liu Z, Zhu K, et al. (2013) Transanal endoscopic microsurgery versus laparoscopic lower anterior resection for the treatment of T1-2 rectal cancers. Hepato-Gastroenterology 60(124): 727–32 [PubMed: 23159393]Kawaguti 2014
Kawaguti F, Nahas C, Marques C, et al. (2014) Endoscopic submucosal dissection versus transanal endoscopic microsurgery for the treatment of early rectal cancer. Surgical Endoscopy and Other Interventional Techniques 28(4): 1173–1179 [PubMed: 24232053]Kiriyami 2011
Kiriyama S, Saito Y, Matsuda T, et al. (2011) Comparing endoscopic submucosal dissection with transanal resection for non-invasive rectal tumour: A retrospective study. Journal of Gastroenterology and Hepatology 26(6): 1028–1033 [PubMed: 21299616]Lezoche 2012
Lezoche E, Baldarelli M, Lezoche G, et al. (2012) Randomized clinical trial of endoluminal locoregional resection versus laparoscopic total mesorectal excision for T2 rectal cancer after neoadjuvant therapy. British Journal of Surgery 99(9): 1211–1218 [PubMed: 22864880]National Comprehensive Cancer Network 2010
National Comprehensive Cancer Network (2010) National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Rectal Cancer. Version 1Park 2012
Park S, Min Y, Shin J, et al. (2012) Endoscopic submucosal dissection or transanal endoscopic microsurgery for nonpolypoid rectal high grade dysplasia and submucosa-invading rectal cancer. Endoscopy 44(11): 1031–1036 [PubMed: 23012217]Winde 1997
Winde G, Blasius G, Herwig R, et al. (1997) Benefit in therapy of superficial rectal neoplasms objectivized: Transanal endoscopic microsurgery (TEM) compared to surgical standards. Minimally Invasive Therapy and Allied Technologies 6(4): 315–323Yan 2016
Yan F, Lou Z, Hu S, et al. (2016) Endoscopic submucosal dissection versus transanal local excision for rectal carcinoid: A comparative study. World Journal of Surgical Oncology 14(1): 162 [PMC free article: PMC4915057] [PubMed: 27324379]
Appendices
Appendix A. Review protocol
Review protocol for review question: What is the most effective treatment for early rectal cancer?
Table 3. Review protocol for effective treatment for early rectal cancer
Appendix B. Literature search strategies
Literature search strategies for review question: What is the most effective treatment for early rectal cancer?
A combined search was conducted for the following three review questions:
- What is the most effective treatment for early rectal cancer?
- What is the effectiveness of preoperative radiotherapy or chemoradiotherapy for rectal cancer?
- What is the optimal surgical technique for rectal cancer?
Database: Embase/Medline
Last searched on: 12/02/2019
| # | Search |
|---|---|
| 1 | exp Rectal Neoplasms/ use prmz |
| 2 | *rectum cancer/ or *rectum tumour/ |
| 3 | 2 use oemezd |
| 4 | exp Adenocarcinoma/ |
| 5 | (T1 or T2 or N0 or M0).ti,ab. |
| 6 | 1 or 3 |
| 7 | 4 or 5 |
| 8 | 6 and 7 |
| 9 | ((rectal or rectum) adj3 (cancer* or neoplas* or malignan* or tumo?r* or carcinom* or adeno*)).ti,ab. |
| 10 | early rect* cancer.ti,ab. |
| 11 | 6 or 8 or 9 or 10 |
| 12 | exp radiotherapy/ or exp radiation oncology/ or exp external beam radiotherapy/ or exp Brachytherapy/ or exp preoperative care/ or exp neoadjuvant therapy/ or exp multimodality cancer therapy/ or exp chemotherapy/ or exp antineo-plastic agent/ or exp drug therapy/ or exp chemoradiotherapy/ or exp fluorouracil/ or exp folinic acid/ or exp capecitabine/ or exp oxaliplatin/ or exp bevacizumab/ or exp methotrexate/ or exp radiation dose fractionation/ or exp tumour recurrence/ |
| 13 | 12 use oemezd |
| 14 | exp Radiotherapy/ or exp Radiation Oncology/ or exp Radiotherapy, Computer-Assisted/ or exp Brachytherapy/ or exp Preoperative Care/ or exp Neoadjuvant Therapy/ or exp Combined Modality Therapy/ or exp Chemoradiotherapy/ or exp Antineoplastic Combined Chemotherapy Protocols/ or exp Drug Therapy/ or exp Antineoplastic Agents/ or exp Fluorouracil/ or exp Leucovorin/ or exp Capecitabine/ or exp Bevacizumab/ or exp Methotrexate/ or exp Dose Fractionation/ |
| 15 | 14 use prmz |
| 16 | ((radiotherap* or chemoradio* or radiation or brachytherapy* or chemotherapy*) adj (pre?op* or preop* or periop* or neoadjuvant)).ti,ab. |
| 17 | (5-fluorouracil or 5-FU or leucovorin or folinic acid or capecitabine or oxaliplatin or bevacizumab or methotrexate or dose* or fraction* or recurren*).ti,ab. |
| 18 | 13 or 15 or 16 or 17 |
| 19 | exp Laparoscopy/ or exp Transanal Endoscopic Microsurgery/ or exp Minimally Invasive Surgical Procedures/ or exp Endoscopy/ or exp Endoscopic Mucosal Resection/ or exp Surgical Procedures, Operative/ or exp Robotic Surgical Procedures/ or exp Surgery, Computer-Assisted/ or exp Dissection/ |
| 20 | 19 use prmz |
| 21 | exp laparoscopy/ or exp endoscopic surgery/ or exp transanal endoscopic microsurgery/ or exp endoscopy/ or exp minimally invasive surgery/ or exp endoscopic mucosal resection/ or exp surgery/ or exp robotic surgical procedure/ or exp computer assisted surgery/ or exp dissection/ or exp total mesorectal excision/ or exp excision/ or exp rectum resection/ or exp endoscopic polypectomy/ or exp polypectomy/ or exp endoscopic submucosal dissection/ |
| 22 | 21 use oemezd |
| 23 | (laparoscop* or endoscop* or transanal excision* or TAE or transanal endoscopic microsurger* or TEM or TEMS or transanal resection or TART or transanal minimally invasive surger* or TAMIS or total mesorectal excision* or TaTME or transanal total mesorectal excision* or TME or anterior resection* or abdominoperineal resection* or endoscopic resection* or polypectomy or endoscopic submucosal dissection* or ESD or endoscopic mucosal resection* or EMR or surger* or surgic* or operat*).ti,ab. |
| 24 | 20 or 22 or 23 |
| 25 | 11 and 18 |
| 26 | 11 and 18 and 24 |
| 27 | 25 or 26 |
| 28 | limit 27 to english language |
| 29 | limit 28 to yr=“1997 -Current” |
| 30 | (conference abstract or letter).pt. or letter/ or editorial.pt. or note.pt. or case report/ or case study/ use oemezd |
| 31 | Letter/ or editorial/ or news/ or historical article/ or anecdotes as topic/ or comment/ or case report/ use prmz |
| 32 | (letter or comment* or abstracts).ti. |
| 33 | or/30–32 |
| 34 | randomized controlled trial/ use prmz |
| 35 | randomized controlled trial/ use oemezd |
| 36 | random*.ti,ab. |
| 37 | or/34–36 |
| 38 | 33 not 37 |
| 39 | (animals/ not humans/) or exp animals, laboratory/ or exp animal experimentation/ or exp models, animal/ or exp rodentia/ use prmz |
| 40 | (animal/ not human/) or nonhuman/ or exp animal experiment/ or exp experimental animal/ or animal model/ or exp rodent/ use oemezd |
| 41 | (rat or rats or mouse or mice).ti. |
| 42 | 38 or 39 or 40 or 41 |
| 43 | 29 not 42 |
| 44 | clinical Trials as topic.sh. or (controlled clinical trial or pragmatic clinical trial or randomized controlled trial).pt. or (placebo or randomi#ed or randomly).ab. or trial.ti. |
| 45 | 44 use prmz |
| 46 | crossover procedure/ or double blind procedure/ or randomized controlled trial/ or single blind procedure/ or (assign* or allocat* or crossover* or cross over* or ((doubl* or singl*) adj blind*) or factorial* or placebo* or random* or volunteer*).ti,ab. |
| 47 | 46 use oemezd |
| 48 | or/45,47 |
| 49 | 43 and 48 |
| 50 | epidemiologic studies/ or observational study/ or case control studies/ or retrospective studies/ or cohort studies/ or longitudinal studies/ or follow-up studies/ or prospective studies/ or cross-sectional studies/ |
| 51 | 50 use prmz |
| 52 | exp observational study/ or exp case control study/ or exp retrospective study/ or exp cohort analysis/ or exp longitudinal study/ or exp follow up/ or exp prospective study/ or exp cross-sectional study/ |
| 53 | 52 use oemezd |
| 54 | ((retrospective* or cohort* or longitudinal or follow?up or prospective or cross section*) adj3 (stud* or research or analys*)).ti. |
| 55 | 51 or 53 or 54 |
| 56 | 43 and 55 |
| 57 | 49 or 56 |
| 58 | 57 not 56 |
| 59 | 56 or 58 |
Database: Cochrane Library
Last searched on: 12/02/2019
| # | Search |
|---|---|
| 1 | MeSH descriptor: [Rectal Neoplasms] explode all trees |
| 2 | MeSH descriptor: [Adenocarcinoma] explode all trees |
| 3 | T1 or T2 or N0 or M0 |
| 4 | #2 or #3 |
| 5 | #1 and #4 |
| 6 | (rectal or rectum) near (cancer* or neoplas* or malignan* or tumo?r* or carcinom* or adeno*) |
| 7 | early rect* cancer |
| 8 | #1 or #5 or #6 or #7 |
| 9 | MeSH descriptor: [Radiotherapy] explode all trees |
| 10 | MeSH descriptor: [Radiation Oncology] explode all trees |
| 11 | MeSH descriptor: [Radiotherapy, Computer-Assisted] explode all trees |
| 12 | MeSH descriptor: [Brachytherapy] explode all trees |
| 13 | MeSH descriptor: [Preoperative Care] explode all trees |
| 14 | MeSH descriptor: [Neoadjuvant Therapy] explode all trees |
| 15 | MeSH descriptor: [Combined Modality Therapy] explode all trees |
| 16 | MeSH descriptor: [Chemoradiotherapy] explode all trees |
| 17 | MeSH descriptor: [Antineoplastic Combined Chemotherapy Protocols] explode all trees |
| 18 | MeSH descriptor: [Drug Therapy] explode all trees |
| 19 | MeSH descriptor: [Antineoplastic Agents] explode all trees |
| 20 | MeSH descriptor: [Fluorouracil] explode all trees |
| 21 | MeSH descriptor: [Capecitabine] explode all trees |
| 22 | MeSH descriptor: [Bevacizumab] explode all trees |
| 23 | MeSH descriptor: [Methotrexate] explode all trees |
| 24 | MeSH descriptor: [Dose Fractionation] explode all trees |
| 25 | (radiotherap* or chemoradio* or radiation or brachytherapy* or chemotherapy*) near (pre?op* or preop* or periop* or neoadjuvant) |
| 26 | 5-fluorouracil or 5-FU or leucovorin or folinic acid or capecitabine or oxaliplatin or bevacizumab or methotrexate or dose* or fraction* or recurren* |
| 27 | #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 |
| 28 | MeSH descriptor: [Laparoscopy] explode all trees |
| 29 | MeSH descriptor: [Transanal Endoscopic Microsurgery] explode all trees |
| 30 | MeSH descriptor: [Minimally Invasive Surgical Procedures] explode all trees |
| 31 | MeSH descriptor: [Endoscopy] explode all trees |
| 32 | MeSH descriptor: [Endoscopic Mucosal Resection] explode all trees |
| 33 | MeSH descriptor: [Surgical Procedures, Operative] explode all trees |
| 34 | MeSH descriptor: [Robotic Surgical Procedures] explode all trees |
| 35 | MeSH descriptor: [Surgery, Computer-Assisted] explode all trees |
| 36 | MeSH descriptor: [Dissection] explode all trees |
| 37 | laparoscop* or endoscop* or transanal excision* or TAE or transanal endoscopic microsurger* or TEM or TEMS or transanal resection or TART or transanal minimally invasive surger* or TAMIS or total mesorectal excision* or TME or anterior resection* or abdominoperineal resection* or endoscopic resection* or polypectomy or endoscopic submucosal dissection* or ESD or endoscopic mucosal resection* or EMR or surger* or surgic* or operat* |
| 38 | #28 or #29 or #30 or #31 or #32 or #33 or #34 or #35 or #36 or #37 |
| 39 | #8 and #27 |
| 40 | #8 and #27 and #38 |
| 41 | #39 or #40 Publication Year from 1997 to 2017 |
Appendix C. Clinical evidence study selection
Clinical evidence study selection for review question: What is the most effective treatment for early rectal cancer?
Appendix D. Clinical evidence tables
Clinical evidence tables for review question: What is the most effective treatment for early rectal cancer?
Table 4. Clinical evidence tables (PDF, 408K)
Appendix E. Forest plots
Forest plots for review question: What is the most effective treatment for early rectal cancer?
Appendix F. GRADE tables
GRADE tables for review question: What is the most effective treatment for early rectal cancer?
Table 6. Clinical evidence profile for comparison 2: Endoscopic resection versus transanal excision
Appendix G. Economic evidence study selection
Economic evidence study selection for review question: What is the most effective treatment for early rectal cancer?
A global search of economic evidence was undertaken for all review questions in this guideline. See Supplement 2 for further information.
Appendix H. Economic evidence tables
Economic evidence tables for reviews question: What is the most effective treat ment for early rectal cancer?
No economic evidence was identified which was applicable to this review question.
Appendix I. Economic evidence profiles
Economic evidence profiles for review question: What is the most effective treat ment for early rectal cancer?
No economic evidence was identified which was applicable to this review question.
Appendix J. Economic analysis
Economic analysis for review question: What is the most effective treatment for early rectal cancer?
No economic analysis was conducted for this review question.
Appendix K. Excluded studies
Excluded clinical studies for review question: What is the most effective treat ment for early rectal cancer?
Appendix L. Research recommendations
Research recommendations for review question: What is the most effective treat ment for early rectal cancer?
No research recommendations were made for this review question.
Final
Evidence reviews
Developed by the National Guideline Alliance part of the Royal College of Obstetricians and Gynaecologists
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.
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- Immediate radical resection after local excision of rectal cancer: an oncologic compromise?[Dis Colon Rectum. 2005]Immediate radical resection after local excision of rectal cancer: an oncologic compromise?Hahnloser D, Wolff BG, Larson DW, Ping J, Nivatvongs S. Dis Colon Rectum. 2005 Mar; 48(3):429-37.
- Results of neoadjuvant short-course radiation therapy followed by transanal endoscopic microsurgery for t1-t2 n0 extraperitoneal rectal cancer.[Int J Radiat Oncol Biol Phys. ...]Results of neoadjuvant short-course radiation therapy followed by transanal endoscopic microsurgery for t1-t2 n0 extraperitoneal rectal cancer.Arezzo A, Arolfo S, Allaix ME, Munoz F, Cassoni P, Monagheddu C, Ricardi U, Ciccone G, Morino M. Int J Radiat Oncol Biol Phys. 2015 Jun 1; 92(2):299-306. Epub 2015 Mar 12.
- Review The impact of transanal local excision of early rectal cancer on completion rectal resection without neoadjuvant chemoradiotherapy: a systematic review.[Tech Coloproctol. 2021]Review The impact of transanal local excision of early rectal cancer on completion rectal resection without neoadjuvant chemoradiotherapy: a systematic review.Zinicola R, Nascimbeni R, Cirocchi R, Gagliardi G, Cracco N, Giuffrida M, Pedrazzi G, Binda GA. Tech Coloproctol. 2021 Sep; 25(9):997-1010. Epub 2021 Jun 25.
- Review Modern management of rectal cancer: a 2006 update.[World J Gastroenterol. 2006]Review Modern management of rectal cancer: a 2006 update.Balch GC, De Meo A, Guillem JG. World J Gastroenterol. 2006 May 28; 12(20):3186-95.
- Treatment for early rectal cancerTreatment for early rectal cancer
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