Clinical trial NCT02388256: Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection
Official title: Acupuncture for Enhanced Recovery After Surgery in Patients Undergoing Laparoscopic Colorectal Cancer Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colon
colorectal
cancer
neoplasm
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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 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

Primary outcomes:
measure: Recovery of physical function
timeFrame: at 2 weeks after surgery
Secondary outcomes:
measure: Pain intensity
timeFrame: 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
measure: Time to first flatus
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Time to tolerate soft diet
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Time to first defecation
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Time to independent walk
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Number of insertions of nasogastric tube
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Incidence of nausea/vomiting
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Time to first removal of Foley catheter
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Number of reinsertions of Foley catheter
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Number of clean intermittent catheterizations
timeFrame: up to 1 week after surgery (an expected period of admission)
measure: Quality of life measured by EORTC QLQ C30
timeFrame: at 2 weeks after surgery, at 4 weeks after surgery, and at 12 weeks after surgery
measure: Patient's global assessment after surgery
timeFrame: at 4 weeks after surgery, at 12 weeks after surgery
measure: Use of medication
timeFrame: 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
measure: Anxiety and depression
timeFrame: at 2 weeks after surgery, at 4 weeks after surgery, at 12 weeks after surgery
measure: Postoperative complications
timeFrame: within 12 weeks after surgery
measure: Serious adverse events
timeFrame: within 12 weeks after surgery
measure: Adverse events related to acupuncture
timeFrame: within 12 weeks after surgery
Other outcomes:
measure: Adherence to enhanced recovery program after surgery
timeFrame: at 1 week after surgery (an expected day of discharge)
Locations:
city: Yangsan
country: Korea, Republic of
facility: National Clinical Research Centre for Korean Medicine, 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: Kyung Mo Son, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korean Medicine Hospital, Pusan National University
name: Gi Young Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: