Annals of surgery
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To evaluate serum CA19-9 alterations during preoperative gemcitabine-based chemoradiation therapy (CRT) for resectable pancreatic cancer (PC) in the earlier identification of patients who are likely to benefit from subsequent resection. ⋯ CA19-9 alteration status is useful in identifying those who will benefit from the preoperative CRT and subsequent resection and those who will not; it was a significant predictor for patient prognosis in the setting of the preoperative CRT strategy for resectable PC.
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Randomized Controlled Trial Multicenter Study Comparative Study
Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial).
The aim of this study was to evaluate the safety of this trial with respect to morbidity and mortality. ⋯ There was no significance difference in the morbidity and mortality between the 2 groups. Therefore, we conclude that this trial is safe and is thus ongoing.
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Randomized Controlled Trial Comparative Study
Red blood cell transfusion threshold in postsurgical pediatric intensive care patients: a randomized clinical trial.
The optimal transfusion threshold after surgery in children is unknown. We analyzed the general surgery subgroup of the TRIPICU (Transfusion Requirements in Pediatric Intensive Care Units) study to determine the impact of a restrictive versus a liberal transfusion strategy on new or progressive multiple organ dysfunction syndrome (MODS). ⋯ In this subgroup analysis of pediatric general surgery patients, we found no conclusive evidence that a restrictive red-cell transfusion strategy, as compared with a liberal one, increased the rate of new or progressive MODS or mortality.
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Comparative Study
Long-term outcomes for infants with very low risk Wilms tumor treated with surgery alone in National Wilms Tumor Study-5.
To determine the event-free survival (EFS) and overall survival (OS) of children with very low risk Wilms tumor (VLRWT) treated with surgery only. ⋯ The surgery-only EFS was lower than anticipated but, coupled with a much higher than anticipated salvage rate of the chemotherapy naive patients whose disease recurred, led to an observed long-term OS equivalent to that seen with 2-drug chemotherapy. This approach to the treatment of patients with VLRWT eliminates the toxic side-effects of chemotherapy for a large majority of patients. A follow-up study is underway to confirm these findings.
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Surgical trials pose many methodological challenges often not present in trials of medical interventions. If not properly accounted for, these challenges may introduce significant biases and threaten the validity of the results. ⋯ Many barriers and issues of surgical trials affecting internal validity can be overcome with proper methodology, and in most cases these issues do not restrict their conduct. Researchers should consider their research question carefully and design a surgical trial that contains features appropriate for the question. In doing so, they must ensure that the trial is valid, feasible, and affordable--a difficult feat, but one well worth the challenge.