Non-invasive vagus nerve stimulation to reduce ileus after major colorectal surgery: Early development study.
AIM: Vagus nerve stimulation has emerged as a plausible intervention to reduce ileus after surgery. An early development study was undertaken to explore the feasibility of self-administered, non-invasive vagus nerve stimulation (nVNS) after major colorectal surgery.
METHOD: A parallel-group, randomised controlled trial was undertaken between 1st January 2018 and 31st August 2019. Forty patients undergoing colorectal surgery for malignancy were allocated equally to Sham and Active stimulation groups. Electrical vagus nerve stimulation was self-administered bilaterally over the cervical surface landmarks for five days before and after surgery. Outcomes of interest were post-operative complications and adverse events measured using the Clavien-Dindo Classification, treatment compliance, device usability according to the Systems Usability Scale (SUS), and clinical measures of bowel recovery.
RESULTS: Forty patients were randomised and 1 withdrew, leaving 39 for analysis. Post-operative complications occurred in 9/19 (47.4%) participants receiving Sham and 11/20 (55.0%) receiving Active stimulation and were mostly minor. Compliance to treatment before surgery was 4.7 ± 0.9 out of five days in the Sham group and 4.7 ± 1.1 in the Active group. Compliance to treatment after surgery was 4.1 ± 1.1 and 4.4 ± 1.5, respectively. Participants considered the intervention to be “acceptable” according to the SUS. The most prominent differences in bowel recovery were days to first flatus (2.35 ± 1.32 vs. 1.65 ± 0.88) and tolerance of solid diet (2.18 ± 2.21 vs. 1.75 ± 0.91) for Sham and Active groups, respectively.
CONCLUSION: This study supports the safety, treatment compliance, and usability of self-administered nVNS in patients undergoing major colorectal surgery.
PMID: 33539637 [PubMed – as supplied by publisher]
Colorectal Dis. 2021 Feb 04;:
Authors: Chapman SJ, Helliwell JA, Naylor M, Tassinari C, Corrigan N, Jayne DG