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A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus


Phase 2
18 Years
N/A
Not Enrolling
Both
Postoperative Ileus, Colon Cancer, Pain, Postoperative, Postoperative Nausea and Vomiting

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Trial Information

A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus


- 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

end of study

Safety Issue:

No

Principal Investigator

Gary Deng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-145

NCT ID:

NCT00402961

Start Date:

November 2006

Completion Date:

February 2013

Related Keywords:

  • Postoperative Ileus
  • Colon Cancer
  • Pain, Postoperative
  • Postoperative Nausea and Vomiting
  • Acupuncture
  • Post-Colectomy Ileus
  • Abdominal Surgery
  • Colon Surgery
  • Colonic Neoplasms
  • Pain, Postoperative
  • Vomiting
  • Postoperative Nausea and Vomiting
  • Ileus

Name

Location

Memorial Sloan-Kettering Cancer Center 1275 York AvenueNew York, New York  10021