Clinical trial NCT02509143: Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery
Official title: High-dose Acupuncture for Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Colorectal Surgery: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Colorectal Neoplasms
Keywords: Postoperative Nausea and Vomiting
Colorectal Neoplasms
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
name: Korean Medicine Hospital of Pusan National University
First posted: 2015-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: PONV is one of the prevalent discomforts in the early phase of recovery after surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces more benefits compared with P6 stimulation alone or whether acupuncture combined with standard antiemetic medication yields better outcomes.

Objectives: This study aims to assess the effectiveness, safety, and feasibility of intensive acupuncture treatments combined with standard antiemetic medication as compared with P6 acupoint stimulation combined with standard antiemetic medication or with standard antiemetic medication alone.

Detailed description: Background: PONV is one of the prevalent discomforts in the early phase of recovery after surgery. Evidence suggests that the stimulation of the P6 acupuncture point can reduce the occurrence of PONV. What remains unclear is whether a higher dose of acupuncture produces more benefits compared with P6 stimulation alone or whether acupuncture combined with standard antiemetic medication yields better outcomes. This study aims to assess the effectiveness and safety of different acupuncture regimen for the prevention of PONV: high-dose acupuncture treatments combined with standard antiemetic medication, P6 acupuncture-point stimulation combined with standard antiemetic medication, or medication alone.

Objectives: This study aims to assess the effectiveness, safety, and feasibility of intensive acupuncture treatments combined with standard antiemetic medication as compared with P6 acupoint stimulation combined with standard antiemetic medication or with standard antiemetic medication alone, to prevent postoperative nausea and vomiting (PONV) in patients undergoing laparoscopic colorectal surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective laparoscopic surgery of colorectal cancer resection (right hemicolectomy, left hemicolectomy, anterior resection with primary anastomosis, and low anterior resection with loop ileostomy for fecal diversion)
* Patients aged 18 to 80
* American Society of Anesthesiologists Grade 1 to 2
* Written informed consents

Exclusion Criteria:

* Pregnancy
* Inflammatory bowel disease
* Comorbidities that may affect outcomes of surgery (e.g., chronic kidney disease, chronic liver disease, cardiopulmonary failure, and diabetes with complications)
* Use of emetogenic / antiemetic medication within 24 hours before surgery
* Previous history of emetic episodes after administration of antibiotics
* Expected use of mechanical ventilation
* Cognitive impairment that may affect the patient's ability to complete the outcome assessments
* Previous history of stroke
* Previous history of sensitive reaction to acupuncture
* Patients unable to cooperate with acupuncture treatments
* Pacemaker implantation
* Previous history of epilepsy
* Patients who have received Korean medicine treatments (acupuncture, moxibustion, cupping, or herbal medicine) within 2 weeks
* Patients who have participated in other trials within 3 months

Primary outcomes:
measure: Number of patients who experience moderate or severe level nausea or vomiting
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: Nausea scores on a numeric rating scale
timeFrame: at baseline (the discharge of recovery room), 6, 12, 24, 48 hours from baseline and at discharge (until discharge, an expected average of 7 days after surgery)
measure: Number of vomiting
timeFrame: from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery)
measure: Cumulative incidence of vomiting
timeFrame: at baseline to 24 and 48 hours
measure: Number of patients who experience nausea
timeFrame: from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery)
measure: Cumulative number of patients who experience nausea
timeFrame: at baseline to 24 and 48 hours
measure: Number of patients who experience vomiting
timeFrame: from the discharge of recovery room to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 hours to the discharge (until discharge, an expected average of 7 days after surgery)
measure: Cumulative number of patients who experience vomiting
timeFrame: at baseline to 24 and 48 hours
measure: Pain scores on a numeric rating scale
timeFrame: at 6, 12, 24, 48 hours from the discharge of recovery room and at discharge (until discharge, an expected average of 7 days after surgery)
measure: Patient's global assessment of recovery after surgery
timeFrame: at 2 weeks after surgery
measure: Time to first flatus
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Time to tolerate soft diet
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Time to first defecation
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Time to independent walk
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Number of insertions of nasogastric tube
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Time to first removal of Foley catheter
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Number of reinsertions of Foley catheter
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Number of clean intermittent catheterizations
timeFrame: until discharge, an expected average of 7 days after surgery
measure: Quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30
timeFrame: at 2 weeks after surgery
measure: Preoperative anxiety
timeFrame: just before the induction of anaesthesia
measure: Patient-reported satisfaction for management of PONV
timeFrame: at 48 hours after surgery
measure: Use of medication
timeFrame: at 2 weeks after surgery
measure: Postoperative complications
timeFrame: within 4 weeks after surgery
measure: Serious adverse events
timeFrame: within 4 weeks after surgery
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: National Clinical Research Center, Korean Medicine Hospital, Pusan National University
state: Kyung Sang South Province
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyung Sang South Province
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Hee Young Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KH, Kim DH, Bae JM, Son GM, Kim KH, Hong SP, Yang GY, Kim HY. 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. BMJ Open. 2017 Jan 4;7(1):e013457. doi: 10.1136/bmjopen-2016-013457.