Effect of a multimodal bundled intervention on quality of recovery after laparoscopic colorectal cancer surgery: a single-center, single-blind, pragmatic randomized controlled trial
摘要
Despite the minimally invasive nature of laparoscopic colorectal surgery, postoperative recovery is frequently compromised by pain, fatigue, and delayed gastrointestinal function. Current rehabilitation strategies largely rely on unimodal approaches, and evidence for structured multimodal bundled interventions is limited. This study aimed to evaluate whether a multimodal bundled intervention comprising electroacupuncture, abdominal massage, structured breathing training, and symptom-titrated supervised ambulation improves quality of recovery in patients undergoing laparoscopic surgery for stage I–III colorectal cancer.
MethodsThis single-center, single-blind, parallel-group, pragmatic randomized controlled trial randomized 105 patients to either a multimodal bundled intervention plus standard care or standard care alone. The intervention group received electroacupuncture and structured breathing training from postoperative day 1 to 7, with abdominal massage and symptom-titrated supervised ambulation added from postoperative day 4 to 7. The primary outcome was the trajectory of the Quality of Recovery-15 (QoR-15) score assessed at postoperative days 3, 7, and 30. Statistical analyses followed a modified intention-to-treat principle.
ResultsOf 105 randomized patients, 90 (45 per group) were included in the final analysis. A significant group-by-time interaction was observed for QoR-15 scores (P = 0.043). While no significant between-group differences were found at postoperative days 3 or 7, the intervention group demonstrated significantly higher QoR-15 scores at postoperative day 30 (mean difference 11.33; 95% confidence interval 3.41 to 19.26; P = 0.005). Secondary outcomes, including pain intensity and perceived exertion, showed favorable between-group differences at later postoperative assessments. No serious intervention-related adverse events were reported.
ConclusionsIn this single-center pragmatic randomized controlled trial, the multimodal bundled intervention did not significantly improve QoR-15 scores during the early postoperative period at POD3 or POD7. However, it was associated with a clinically meaningful improvement in QoR-15 at POD30. These findings suggest a potential medium-term patient-reported recovery benefit after laparoscopic colorectal cancer surgery, but they should not be interpreted as evidence of accelerated early ERAS-related recovery.
Trial registrationChiCTR2400085191. Registered on June 3, 2024.