Abstract
BACKGROUND: Intestinal dysfunction is not conducive to the recovery of patients after surgery. It is particularly important to restore the intestinal function as soon as possible. In recent years, ultrasonic drug penetration therapy as a new type of non-invasive therapy has been used to solve this problem, but its efficacy has not been confirmed. METHODS: Single-centre, parallel, randomized controlled clinical trial in China that included 184 patients undergoing laparoscopic gastrointestinal surgery. Ninety-one participants were randomly assigned to low-frequency ultrasound and electric pulses for transdermal drug delivery with Dachengqi Decoction (DCQD) (intervention group), and 90 were assigned to the control group after laparoscopic gastrointestinal surgery. The primary outcome was time to first flatus after surgery (by patient's subjective feeling). Secondary outcomes assessed the recovery time of bowel movement, time of the first defecation, postoperative gastrointestinal complications (e.g., nausea, vomit, and bloating), days of hospitalization and treatment costs. RESULTS: Of 184 patients, 181 (98.4%) completed the trial. The sociodemographic characteristics and efficiency data were comparable in the two groups at baseline. The intervention group had a shorter mean time of bowel movement recovery than the control group [29.4 h (IQR, 22.0-35.0 h) vs. 33.7 h (IQR, 24.0-40.0 h; P=0.005)] and a shorter mean time to first flatus after surgery [35.8 h (IQR, 23.1-46.6 h) vs. 46.7 h (IQR, 25.9-61.3 h; P=0.012)]. Postoperative gastrointestinal reactions (e.g., nausea, vomit, and bloating) occurred in 28.6% in the intervention group and 43.3% in the control group (P=0.038). Two patients in the intervention group had electrical tingling sensations, and one patient had a skin rash during the treatment. There were no significant differences in the occurrence rates of AEs or SAE, days of hospitalization and treatment costs between the two groups. CONCLUSIONS: Low-frequency ultrasound and electric pulses for transdermal drug delivery with DCQD can shorten the time of bowel movement recovery and accelerate first anal exhaust after laparoscopic gastrointestinal surgery. TRAIL REGISTRATION: Chictr.org.cn Identifier: ChiCTR-IPR-17013630.