Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection

Colorectal Cancer Clinical Trial

Official title:

Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388256
• Other study ID #: 03-2014-012
• Status: Completed
• Phase: N/A
• First received: March 1, 2015
• Last updated: June 25, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Background:

Patients who undergo laparoscopic surgical resection of colorectal cancer may experience various post-operative symptoms (e.g., pain, nausea and vomiting, and anxiety) and limitation of daily activities (e.g., walking capacity). There is also a risk of post-operative complications and a prolonged hospital stay due to complications. Patients who underwent surgical resection may have experienced chronic pain, anxiety/depression, or diminished quality of life. The physical, psychological, and functional aspects of patients' disorders imply the necessity of multidisciplinary care, including complementary or traditional medicines such as acupuncture. This study aims to assess whether acupuncture treatment, combined with an enhanced recovery program after surgery in an inpatient care setting is effective than only an enhanced recovery program after surgery.

Objective:

To assess the effectiveness and safety of acupuncture combined with an enhanced recovery program after surgery to reduce postoperative symptoms and improve functional recovery and the patients' quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 75

• American Society of Anesthesiologists Grade 1 to 2

• Eastern Cooperative Oncology Group Grade 0 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)

• Resection of other organs for radical removal of colorectal cancer

• Patients requiring enterolysis due to previous history of abdominal surgery

• Obstructive colorectal cancer

• Metastatic colorectal cancer

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• acupuncture
Points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4) and Pericardium 6 (PC6) will be used. Electrical stimulation with alternating frequency of 2 to 100 Hz will be applied to the selected points (LI4 to LI11, ST36 to ST37, and bilateral SP6). Rationale of acupuncture treatments will include both traditional theory of harmonizing gastrointestinal function and strengthening vital energy as well as modern experimental and clinical evidence of regulating gastrointestinal motility and other symptom managements. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience.

Other:
• early recovery program after surgery
An enhanced recovery program after surgery that was designed and is currently implemented by surgeons, anesthetists, dietitians, and nurses will be provided. The program includes preoperative education, early water/food intake, early mobilization, early removal of Foley catheter and drains, structured nursing care, and nutritional support.

Locations

Country	Name	City	State
Korea, Republic of	National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University	Yangsan	Kyung Sang South Province
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyung Sang South Province

Sponsors (1)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to enhanced recovery program after surgery	Number of patients who discharge the hospital at the expected day as planned	at 1 week after surgery (an expected day of discharge)	No
Primary	Recovery of physical function	Recovery of physical function, as measured by the physical function domain of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 instrument	at 2 weeks after surgery	No
Secondary	Pain intensity	Pain scores on a numeric rating scale. Score ranges from 0 (no pain at all) to 10 (the worst pain imaginable)	at 4, 12, 24, 48, 72 hours after surgery, at 1 week after surgery (an expected day of discharge), at 2 weeks after surgery, and at 4 weeks after surgery	No
Secondary	Time to first flatus	elapsed time after surgery	up to 1 week after surgery (an expected period of admission)	No
Secondary	Time to tolerate soft diet	elapsed time after surgery	up to 1 week after surgery (an expected period of admission)	No
Secondary	Time to first defecation	elapsed time after surgery	up to 1 week after surgery (an expected period of admission)	No
Secondary	Time to independent walk	elapsed time after surgery	up to 1 week after surgery (an expected period of admission)	No
Secondary	Number of insertions of nasogastric tube	number of insertions of nasogastric tube	up to 1 week after surgery (an expected period of admission)	No
Secondary	Incidence of nausea/vomiting	number of nausea / vomiting reported by the patients	up to 1 week after surgery (an expected period of admission)	No
Secondary	Time to first removal of Foley catheter	elapsed time after surgery	up to 1 week after surgery (an expected period of admission)	No
Secondary	Number of reinsertions of Foley catheter	number of reinsertions of Foley catheter	up to 1 week after surgery (an expected period of admission)	No
Secondary	Number of clean intermittent catheterizations	number of clean intermittent catheterizations	up to 1 week after surgery (an expected period of admission)	No
Secondary	Quality of life measured by EORTC QLQ C30	Quality of life measured by EORTC QLQ C30	at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery	No
Secondary	Patient's global assessment after surgery	Response options include very much improved, somewhat improved, no change, somewhat worsened, and very much worsened.	at 4 weeks after surgery, at 12 weeks after surgery	No
Secondary	Use of medication	Use of analgesics, antiemetics and other medications after surgery	at 1 week after surgery (an expected day of discharge), at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery	No
Secondary	Anxiety and depression	Patients' anxiety and depression level measured by the Hospital Anxiety-Depression Scale	at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery	No
Secondary	Postoperative complications	wound infection; urinary tract infection; urinary retention; chest infection; other infection; paralytic ileus	within 12 weeks after surgery	Yes
Secondary	Serious adverse events	respiratory failure requiring ventilation; renal failure requiring dialysis; cardiac failure; myocardial infarction; anastomotic leakage requiring surgery; anastomotic leakage requiring drainage; bowel obstruction/stricture requiring surgery; abdominal wall dehiscence requiring surgery; readmission within 30 days after surgery; reoperation within 30 days after surgery; mortality during surgery or within 30 days after surgery	within 12 weeks after surgery	Yes
Secondary	Adverse events related to acupuncture	Expected or unexpected adverse events that are considered to be associated with acupuncture treatments.	within 12 weeks after surgery	Yes