Randomized controlled trials in surgical oncology: where do we stand? (original) (raw)
Related papers
The role of clinical trials in the development of novel surgical techniques
Journal of Surgical Oncology, 2007
The new paradigm and standard for medicine and surgery is the evidence-based practice for which the randomized controlled trial is fundamental. Despite the early involvement of surgeons in clinical trials, randomized trials testing novel surgical therapies are not common. Indeed, only 24% of surgical patients are managed based on level 1 evidence. This chapter details how randomized controlled trial methodologies facilitate the development of level 1 evidence in support of minimally invasive colon cancer surgery.
Clinical Research in Surgical Oncology: An Analysis of ClinicalTrials.gov
Annals of Surgical Oncology, 2013
Background. The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov. Methods. Data was extracted from ClinicalTrials.gov using the following search engine criteria: ''Cancer'' as Condition, ''Surgery OR Operation OR Resection'' as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. Results. Of 9,961 oncology trials, 1,049 (10.5 %) included any type of surgical intervention. Of these trials, 125 (11.9 %, 1.3 % of all oncology trials) assessed a surgical variable, 773 (73.7 %) assessed adjuvant/neoadjuvant therapies, and 151 (14.4 %) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8 %) and multimodal therapy (129 trials, 16.7 %) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2 %) focused on surgical techniques or devices, 45 trials (36.0 %) studied invasive diagnostic methods, and 21 trials (16.8 %) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6 %).
Development and perspectives of randomized controlled trials in surgery
The American Journal of Surgery, 2007
After introduction of the randomized controlled trial (RCT) into clinical research within the second half of the 20th century, the number of high-quality RCTs comparing surgical techniques has been low, although this trial design has widely been acknowledged to provide the highest available level of evidence. Reasons for the paucity of RCTs dealing with surgical techniques have been attributed to specific challenges of these trials requiring elaborate methodologic considerations, as well as complex organization, raising questions regarding their feasibility. However, unrelenting efforts of certain clinicians who realized surgical trials, even in times of weak infrastructure for clinical research in surgery, have proved that RCTs are feasible, even within daily clinical routine. Furthermore, these trials helped to increase awareness for the need of more surgical RCTs among clinicians and individuals in charge of funding institutions. As a result, a positive development of patient-oriented surgical research has been observed within the last years. The number of surgeons willing to participate in trials is rising. In addition, increased financial support from governmental institutions could be obtained to establish a working infrastructure for surgical research. Nonetheless, there are still issues of surgical RCTs regarding their quality, reporting, and study design. Addressing these aspects is essential for successful continuation of what was initiated with the first surgical RCT more than 40 years ago.
Ejso, 2021
Where surgery forms the primary curative modality in surgical oncology trials the quality of this intervention has the potential to directly influence outcomes. Many trials however lack a robust framework to ensure surgical quality. We aim to report existing published challenges to quality assurance of surgical interventions within oncological trials. A systematic on-line literature search of Embase and Medline identified 34 relevant studies, including 19 RCTs, 11 further analyses of the primary RCTs, and 4 trial protocols. Inclusion criteria: oncological RCTs with a surgical intervention and/or associated publications relevant to the research question; 'Challenges to quality assurance of surgery in clinical oncology trials'. Selected articles were assessed by two reviewers to identify reported challenges to quality assurance of surgical intervention within these trials. Reported challenges to surgical quality could be classified as those affecting credentialing, standardisation and monitoring of surgical interventions. Constraints of using case volume for credentialing surgeons; inter-centre variation in the definition and execution of interventions; insufficient training, and monitoring of surgical quality, were the most commonly encountered challenges within each of these three domains. Findings confirmed an inadequacy in the implementation and reporting of effective surgical quality assurance measures. The surgical community should enable implementation of agreed upon mitigating strategies to overcome challenges to surgical quality in oncology trials.
BMC Surgery, 2008
Background: Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC) strategy. The strategy is designed to optimize the use of total mesorectal excision techniques.
Users' guide to the surgical literature. How to assess a randomized controlled trial in surgery
PubMed, 2004
You are a new plastic surgeon in the community and you are referred a patient interested in breast reconstruction. The patient is a 35-year-old female school teacher who had a bilateral prophylactic mastectomy 2 years earlier, as she was a BRCA gene carrier. Since she is of a petite build with very little subcutaneous tissue or extra skin in the lower abdomen, you decide that she is not a suitable candidate for an abdomen-based autologous tissue reconstruction. You recommend the technique of tissue expansion and silicone gel implants. She is concerned, however, about the possibility of anaplastic large cell lymphoma (ALCL) developing in her breasts. She read in a magazine recently that ALCL, an unusual form of breast cancer, has been occurring in patients who have breast implants. She is very concerned that she might be at risk and asks for your opinion as to whether she should proceed with the procedure or not.
Surgery, 2009
The author reviewed the first issue of 9 general surgery journals in 1996 and found that only 7% of papers reported data derived from a randomized trial, whereas 46% were based on case series. A decade later , we conducted a similar survey and found that the relative percentage of case series, operationally defined as a single institution's experience with a single procedure, had decreased to 34%. At the same time, we found that the relative number of cohort studies (51%) and the relative percentage of articles reporting data derived from a randomized trial (10%) remained relatively similar.
A debate on the value and necessity of clinical trials in surgery
The American Journal of Surgery, 2003
In the current era of evidence-based medicine there is increasing demand for randomized clinical trials (RCTs) in surgery. Unfortunately, many unique aspects of surgery make RCTs difficult to implement. This article is a debate that explores the motion that clinical trials in surgery are both useful and necessary.
Randomised trials in surgery: problems and possible solutions
BMJ, 2002
The quality and quantity of randomised trials of surgical techniques is acknowledged to be limited. According to Peter McCulloch and colleagues, however, some aspects of surgery present special difficulties for randomised trials. In this article they analyse what these difficulties are and propose some solutions for improving the standards of clinical research in surgery Education and debate