A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
18 Years
N/A
Both
Colorectal Cancer, Gastrointestinal Complications, Nausea and Vomiting, Pain, Perioperative/Postoperative Complications
Trial Information
A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
OBJECTIVES:
Primary
- Determine whether a phase III study of acupuncture for postoperative recovery after
colorectal surgery is warranted, as defined by evidence of reduction of postoperative
ileus in patients who undergo acupuncture vs sham acupuncture after segmental or
subtotal colectomy with primary anastomosis for colorectal cancer.
Secondary
- Determine whether acupuncture reduces the length of hospital stay more than sham
acupuncture.
- Determine whether acupuncture improves patient satisfaction with the hospital
experience by ameliorating other postoperative symptoms, such as pain, nausea, and
vomiting.
- Determine the feasibility of a phase III trial, in terms of sample size, accrual rate,
attrition rate, and data completion.
OUTLINE: This is a randomized, prospective, placebo-controlled study. Patients are
stratified according to type of colectomy (segmental vs subtotal). Patients are randomized
to 1 of 2 treatment arms.
- Arm I (acupuncture): Patients undergo acupuncture over 30 minutes twice daily on days
1-3 after surgery. Electrical stimulation is applied to 2 pairs of acupuncture points.
- Arm II (sham acupuncture): Patients undergo sham acupuncture over 30 minutes twice
daily on days 1-3 after surgery.
Bowel function, pain, and nausea and vomiting are assessed daily until hospital discharge.
Patients complete two treatment-related questionnaires after completion of study therapy.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed or suspected colorectal cancer
- Has undergone elective segmental or subtotal colectomy with primary anastomosis
- No requirement for ileostomy or colostomy
- No resection incorporating the upper gastrointestinal tract
- No gross fecal spillage
- No complications during surgery requiring a patient's transfer to the Intensive
Care Unit (ICU) directly from the operating room or Post Anesthesia Care Unit
(PACU)
- Patients who are transferred to the floor first and who subsequently
require transfer to ICU are eligible
- No requirement for leaving the intraoperative nasogastric tube in place
- No postoperative epidural anesthetics or epidural opioids
PATIENT CHARACTERISTICS:
- No prior serious adverse event with acupuncture
- No contraindication to use of electrical stimulation, including cardiac pacemaker and
implantable cardioverter defibrillator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior major abdominal or pelvic surgery
- Prior uncomplicated appendectomy, cholecystectomy, or hysterectomy performed
more than 3 years ago allowed
- No prior laparoscopic procedure
- No acupuncture within the past 4 weeks
- No concurrent epidural anesthetics or epidural opioids
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Time to recovery of gastrointestinal (GI) function (GI-3), as defined by the time the patient first tolerates solid food, or the time the patient first passes flatus or has a bowel movement, whichever occurs later
Safety Issue:
No
Principal Investigator
Gary E. Deng, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
Unspecified
Study ID:
CDR0000525776
NCT ID:
NCT00425412
Start Date:
November 2006
Completion Date:
Related Keywords:
- Colorectal Cancer
- Gastrointestinal Complications
- Nausea and Vomiting
- Pain
- Perioperative/Postoperative Complications
- nausea and vomiting
- pain
- gastrointestinal complications
- perioperative/postoperative complications
- stage III colon cancer
- stage IV colon cancer
- stage III rectal cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- stage I colon cancer
- stage II colon cancer
- stage I rectal cancer
- stage II rectal cancer
- Colorectal Neoplasms
- Nausea
- Vomiting
- Postoperative Complications
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
