Objective:

2

To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care.

Methods:

2

A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1–3

combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus

time to first tolerance of liquid or semi-liquid food

gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex

age

tumor site

surgical time

histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded.

Results:

2

A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7±12.1 years; 50 males (46.7%)

]

were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference –11.01 h (95% CI –20.75 to –1.28 h)

P

=0.012 for defecation; –5.41 h (–11.10 to 0.27 h)

P

=0.040 for flatus

]

than the placebo group. Moreover

the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (

P

<

0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male

or under 60 years old

or surgical time less than 3 h

or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events.

Conclusion:

2

The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242)