Acupuncture and PC6 stimulation for the prevention of postoperative nausea and vomiting in patients undergoing elective laparoscopic resection of colorectal cancer: a study protocol for a three-arm randomised pilot trial

Kun Hyung Kim, Dae Hun Kim, Ji Min Bae, Gyung Mo Son, Kyung Hee Kim, Seung Pyo Hong, Gi Young Yang, Hee Young Kim, Kun Hyung Kim, Dae Hun Kim, Ji Min Bae, Gyung Mo Son, Kyung Hee Kim, Seung Pyo Hong, Gi Young Yang, Hee Young Kim

Abstract

Introduction: This study aims to assess the feasibility of acupuncture and a Pericardium 6 (PC6) wristband as an add-on intervention of antiemetic medication for the prevention of postoperative nausea and vomiting (PONV) in patients undergoing elective laparoscopic colorectal cancer resection.

Methods and analysis: A total of 60 participants who are scheduled to undergo elective laparoscopic resection of colorectal cancer will be recruited. An enhanced recovery after surgery protocol using standardised antiemetic medication will be provided for all participants. Participants will be equally randomised into acupuncture plus PC6 wristband (Acupuncture), PC6 wristband alone (Wristband), or no acupuncture or wristband (Control) groups using computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. For the acupuncture combined with PC6 wristband group, the embedded auricular acupuncture technique for preoperative anxiolysis and up to three sessions of acupuncture treatments with manual and electrical stimulation within 48 hours after surgery will be provided by qualified Korean medicine doctors. The PC6 wristband will be applied in the Acupuncture and Wristband groups, beginning 1 hour before surgery and lasting 48 hours postoperatively. The primary outcome will be the number of participants who experience moderate or severe nausea, defined as nausea at least 4 out of 10 on a severity numeric rating scale or vomiting at 24 hours after surgery. Secondary outcomes, including symptom severity, participant global assessments and satisfaction, quality of life, physiological recovery, use of medication and length of hospital stay, will be assessed. Adverse events and postoperative complications will be measured for 1 month after surgery.

Ethics and dissemination: All participants will provide written informed consent. The study has been approved by the institutional review board (IRB). This pilot trial will inform a full-scale randomised trial of acupuncture combined with PC6 stimulation for the prevention of PONV in patients undergoing elective laparoscopic colorectal cancer surgery.

Trial registration number: NCT02509143.

Keywords: acupuncture; colorectal cancer; omplementary and alternative medicine; postoperative nausea and vomiting.

Conflict of interest statement

Conflicts of Interest: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Trial flow chart.

References

    1. Gan TJ, Diemunsch P, Habib AS et al. . Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg 2014;118:85–113. 10.1213/ANE.0000000000000002
    1. Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev 2015;(11):CD003281 10.1002/14651858.CD003281.pub4
    1. Cheong KB, Zhang JP, Huang Y et al. . The effectiveness of acupuncture in prevention and treatment of postoperative nausea and vomiting—a systematic review and meta-analysis. PLoS ONE 2013;8:e82474 10.1371/journal.pone.0082474
    1. Streitberger K, Ezzo J, Schneider A. Acupuncture for nausea and vomiting: an update of clinical and experimental studies. Auton Neurosci 2006;129:107–17. 10.1016/j.autneu.2006.07.015
    1. Kim KH, Kim DH, Kim HY et al. . Acupuncture for recovery after surgery in patients undergoing colorectal cancer resection: a systematic review and meta-analysis. Acupunct Med 2016;34:248–56. 10.1136/acupmed-2015-010941
    1. (accessed 1 Feb 2016).
    1. Son KM, Kim KH, Cha SR et al. . Clinical effect of clinical pathway for patients with laparoscopic colon surgery. Journal of Pusan National Univerisity Hospital 2012;31:1–11.
    1. Wind J, Polle SW, Fung Kon Jin PH et al. . Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg 2006;93:800–9. 10.1002/bjs.5384
    1. Usichenko TI, Hesse T. Appropriate timing and intensity of PC6 stimulation for the prevention of postoperative nausea and vomiting. Acupunct Med 2016;34:70–1. 10.1136/acupmed-2015-010926
    1. Alraek T, Birch S. Acupuncture effects under anaesthesia and questions about placebo. Acupunct Med 2016;34: 155–6.
    1. Usichenko TI, Streitberger K. Perioperative acupuncture: why are we not using it? Acupunct Med 2014;32:212–14. 10.1136/acupmed-2014-010580
    1. Yang XY, Xiao J, Chen YH et al. . Dexamethasone alone vs in combination with transcutaneous electrical acupoint stimulation or tropisetron for prevention of postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. Br J Anaesth 2015;115:883–9. 10.1093/bja/aev352
    1. Bae H, Bae H, Min BI et al. . Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med 2014;2014:850367 10.1155/2014/850367
    1. Apfel CC, Korttila K, Abdalla M et al. . A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med 2004;350:2441–51. 10.1056/NEJMoa032196
    1. Gupta D, Lis CG, Rodeghier M. Can patient experience with service quality predict survival in colorectal cancer? J Healthc Qual 2013;35:37–43. 10.1111/j.1945-1474.2012.00217.x
    1. Gupta D, Rodeghier M, Lis CG. Patient satisfaction with service quality in an oncology setting: implications for prognosis in non-small cell lung cancer. Int J Qual Health Care 2013;25:696–703. 10.1093/intqhc/mzt070
    1. Gupta D, Rodeghier M, Lis CG. Patient satisfaction with service quality as a predictor of survival outcomes in breast cancer. Support Care Cancer 2014;22:129–34. 10.1007/s00520-013-1956-7
    1. Yun YH, Park YS, Lee ES et al. . Validation of the Korean version of the EORTC QLQ-C30. Qual Life Res 2004;13:863–8. 10.1023/B:QURE.0000021692.81214.70
    1. Aaronson NK, Ahmedzai S, Bergman B et al. . The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–76. 10.1093/jnci/85.5.365
    1. Fayers PM, Aaronson NK, Bjordal K et al. . The EORTC QLQ-C30 scoring manual. 3rd edn European Organisation for Research and Treatment of Cancer, 2001.
    1. Hansen MV, Halladin NL, Rosenberg J et al. . Melatonin for pre- and postoperative anxiety in adults. Cochrane Database Syst Rev 2015;(4):CD009861 10.1002/14651858.CD009861.pub2
    1. Witt CM, Pach D, Brinkhaus B et al. . Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed 2009;16:91–7. 10.1159/000209315

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir