Clinical trial NCT00402961: Trial of Acupuncture for Reduction of Post-Colectomy Ileus
Official title: A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Ileus
Colon Cancer
Pain, Postoperative
Postoperative Nausea and Vomiting
Keywords: Acupuncture
Post-Colectomy Ileus
Abdominal Surgery
Colon Surgery
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-11-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.

Detailed description: * To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence of reduction of postoperative ileus when compared to sham acupuncture.
* To explore whether acupuncture reduces the length of hospital stay more than sham acupuncture
* To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting.
* To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion.

Postoperative ileus contributes to prolonged hospital stay, readmission and postoperative morbidities in patients undergoing major abdominal surgery. Reduction of postoperative ileus is important in postoperative recovery. Postoperative pain may require opioids, which further reduce gastrointestinal (GI) motility. Postoperative nausea and vomiting hamper the resumption of oral intake. Together, these three common postoperative problems contribute to patient discomfort, delayed discharge and increased overall hospitalization costs, despite current multi-modal management options. Any safe and effective therapy in addition to current standard of care would be welcomed by patients, surgeons and hospitals.

Acupuncture is a complementary medicine modality shown to reduce postoperative pain, suppress nausea and vomiting, and promote GI motility. It is associated with few adverse events. Here we propose a randomized, sham controlled phase II study to evaluate acupuncture, in addition to conventional therapy, for its safety and effectiveness in improving postoperative recovery of colorectal cancer patients undergoing segmental or subtotal colectomy. The overall objective of this developmental project is to determine whether a more extended research project is warranted.

The specific aims are:

* To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence for a reduction of postoperative ileus when compared to sham acupuncture. Hypothesis: acupuncture promotes upper and lower GI motility in patients experiencing postoperative ileus after colectomy more than sham acupuncture.
* To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting. Hypothesis 2a: acupuncture reduces postoperative pain more than placebo in colectomy patients; 2b: acupuncture reduces postoperative nausea and vomiting more than placebo in colectomy patients.
* To determine the feasibility of a phase III trial in terms of sample size, accrual rate, attrition rate and data completion. Hypothesis 3: a phase III study of acupuncture in the treatment of post-colectomy ileus in cancer patients is feasible.

Eligibility criteria: Inclusion Criteria:

* Men or women of any ethnicity
* Age over 18 years (children are not included because colorectal cancer is rare in children).
* Scheduled to undergo elective resection of biopsy proven colorectal cancer or suspected colorectal cancer

Exclusion Criteria:

Pre-operative factors:

* History of major abdominal or pelvic surgery that have caused significant alteration in anatomy and function of the GI tract which may affect the endpoints of this study.
* Laparoscopic procedures. They tend to result in less postoperative ileus.
* Administration of epidural anesthetics or epidural opioids: these have previously been shown to affect postoperative GI motility. They made up only 5% of colectomy patients in the investigators' institution.
* Acupuncture within the last 4 weeks (to exclude any possible residual effect from acupuncture)
* Contraindications to use of electrical stimulation, including cardiac pacemaker and implantable cardioverter defibrillator (ICD)
* Prior serious adverse event with acupuncture
* Intra-operative events (these events alter the postoperative recovery course significantly):

  * Resection incorporating the upper GI tract. Such surgeries are usually more complex, involving more organs and are associated with a more diverse postoperative course, making the study population more heterogeneous.
  * Gross fecal spillage (high complication rate in this setting)
  * Need to leave nasogastric tube in (contaminating the primary endpoint)
  * Decision to give epidural anesthetics or epidural opioids postoperatively (shown previously to change the major endpoints)
  * Complications during surgery requiring a patient to be transferred to the Intensive Care Unit (ICU) directly from the Operating Room or Post Anesthesia Care Unit (PACU) as this also alters the postoperative course significantly. Patients transferred to the floor first will not be excluded. They will be fully registered and randomized. If they deteriorate later during the hospital stay, requiring a transfer to the ICU, they will still be followed.

Primary outcomes:
measure: To determine whether a Phase III trial of acupuncture for postoperative recovery after colorectal surgery is warranted as defined by evidence of reduction of postoperative ileus when compared to sham acupuncture
timeFrame: end of study
Secondary outcomes:
measure: To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting
timeFrame: daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay.
measure: To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion
timeFrame: end of study
measure: GI-2, (also representing time to recovery of gastrointestinal [GI] function)
timeFrame: patient first tolerated solid food,and time patient first passed a bowel movement
measure: GI contractions measured with a multifunctional stethoscope
timeFrame: duration of two minute before and immediately after each true or sham acupuncture treatment.
measure: Daily pain score
timeFrame: daily during hospitalization
measure: Opioid consumption (total dose of morphine equivalent during hospitalization and average dose per day)
timeFrame: daily pain score, opioids consumption (total dose of morphine equivalent during hospitalization and average dose per day) severity of nausea as defined by number of request for PRNantiemetics, and number of emetic episodes during hospital stay.
measure: Number of emetic episodes during hospital stay
timeFrame: assement daily
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center 1275 York Avenue
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: