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Early mobilization after pancreatic surgery: a randomized controlled trial |
Li Z, Zhou L, Li M, Wang W, Wang L, Dong W, Chen J, Gong S |
Surgery 2024 Oct;179(4):1179-1188 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Pancreatic surgery has long been burdened with high postoperative morbidity. Early mobilization has been advocated to prevent complications and improve functional capacity. However, there is a lack of high-quality evidence supporting how to implement early mobilization and its independent impact on postoperative outcomes. The aim of this study was to investigate the effectiveness of implementing early mobilization in reducing postoperative complications and enhancing recovery in patients undergoing pancreatic surgery. METHODS: We conducted a single-blind, randomized trial in patients who underwent pancreatic surgery in a tertiary hospital in China. Eligible participants were randomly assigned to either the control group or the intervention group. Patients in the control group received usual care, whereas those in the intervention group received the early enforced mobilization protocol. The protocol consisted of 2 key components: professional assistance with the first ambulation on postoperative day 1 and family-involved supervision to achieve daily walking goals. The primary outcome was postoperative complications within 30 days, measured by the Comprehensive Complication Index. Secondary outcomes were postoperative mobilization, time to recovery of gastrointestinal function, postoperative pulmonary complications, pancreatic surgery-specific complications, patient-reported outcome measures, and 30-day readmission and mortality. RESULTS: A total of 135 patients were enrolled: 67 in the intervention group and 68 in the control group. The median Comprehensive Complication Index was not statistically significant between groups (mean difference -1.7; 95% confidence interval -8.7 to 0). Patients in the intervention group had earlier first ambulation postoperatively, walked greater distances on postoperative days 1 to 7, and had earlier time to first defecation. Trends for improvement in patient-reported outcomes showed that scores of Quality of Recovery 15 at postoperative day 3, physical function of Quality of Life Questionnaire C30 at postoperative day 7, and global quality of life at postoperative day 30 were significantly greater in the intervention group. There was no between-group difference in other domains of the Quality of Life Questionnaire C30 or other secondary outcome measures. CONCLUSION: Early enforced mobilization intervention did not reduce postoperative complications of patients undergoing pancreatic surgery, but it can enhance postoperative mobilization and improve the recovery of gastrointestinal function and patient-perceived quality of recovery.
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