title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  NCT02509143.
authors.affiliation: School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Kun Hyung
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Department of Acupuncture & Moxibustion, Korean Medicine Hospital, Pusan National University, Yangsan, South Korea.
authors.forename: Dae Hun
authors.initials: DH
authors.lastname: Kim
authors.affiliation: Department of Acupuncture & Moxibustion, Korean Medicine Hospital, Pusan National University, Yangsan, South Korea.
authors.forename: Ji Min
authors.initials: JM
authors.lastname: Bae
authors.affiliation: Department of Surgery, Pusan National University Yangsan Hospital, Yangsan, South Korea.
authors.forename: Gyung Mo
authors.initials: GM
authors.lastname: Son
authors.affiliation: Department of Surgery, Pusan National University Yangsan Hospital, Yangsan, South Korea.
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Kim
authors.affiliation: Department of Acupuncture & Moxibustion, Korean Medicine Hospital, Pusan National University, Yangsan, South Korea.
authors.forename: Seung Pyo
authors.initials: SP
authors.lastname: Hong
authors.affiliation: School of Korean Medicine, Pusan National University, Yangsan, South Korea.
authors.forename: Gi Young
authors.initials: GY
authors.lastname: Yang
authors.affiliation: Department of Anesthesia and Pain Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.
authors.forename: Hee Young
authors.initials: HY
authors.lastname: Kim
mesh_terms: D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000379:methods*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000627:therapeutic use; D015179:Colorectal Neoplasms / Q000601:surgery*; D017558:Elective Surgical Procedures / Q000009:adverse effects; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D007902:Length of Stay; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D020250:Postoperative Nausea and Vomiting / Q000209:etiology / Q000517:prevention & control*; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D012720:Severity of Illness Index; D063189:Symptom Assessment; D004561:Transcutaneous Electric Nerve Stimulation / Q000295:instrumentation / Q000379:methods*; D014953:Wrist; D055815:Young Adult
chemical_list: D000932:Antiemetics
keywords: acupuncture; colorectal cancer; omplementary and alternative medicine; postoperative nausea and vomiting