| Abstract [eng] |
Objective. This research is an intermediate results analysis of a randomized clinical trial ongoing in Lithuania. The objective of this study is to demonstrate that home-based prehabilitation can reduce postoperative morbidity after surgical treatment of gastric cancer. Design and methods. At the moment of the analysis there were 57 patients included in the study who were scheduled for neoadjuvant chemotherapy and surgical treatment for gastric cancer. All patients were randomly assigned to control (n=27) and prehabilitation (n=30) groups. Patients in the control group received routine care from their gastric cancer diagnosis to surgical treatment. Patients in the preoperative rehabilitation group underwent trimodal prehabilitation before surgery consisting of exercises, nutritional correction and psychological help. The primary endpoint of this study was 90-day postoperative morbidity. The secondary endpoints included: intrahospital period mortality; mortality within 90 days after surgical treatment; patients who have completed all scheduled neoadjuvant chemotherapy scheme; patients blood counts before and after the neoadjuvant treatment. Results. The 90-day postoperative morbidity rate did not differ between the control and intervention groups (44.0% vs 41.4%, p=0.999). There were no patients deaths during postoperative hospitalization period. 90-day postoperative mortality rate did not differ between the groups (4.0% vs 3.6%, p=0.999). The proportion of patients completing scheduled neoadjuvant chhemotherapy scheme was higher in preoperative rehabilitation group (85.7% vs 65.4%, p=0.114). There were no significant differences between the groups in blood counts, either at baseline or after non-adjuvant chemotherapy. Conclusions. Obtained results do not suggest that prehabilitation could reduce the postoperative morbidity or mortality rates in gastric cancer patients. In the prehabilitation group, a much larger proportion of patients were able to complete all of their scheduled neoadjuvant chemotherapy scheme, however, the study power is insufficient to demonstrate the significant difference. Comparing the baseline characteristics and treatment received of both groups, the design and randomization process of ongoing randomized clinical trial were found to be appropriate. |
