Trial of Acupuncture for Reduction of Post-Colectomy Ileus

NCT00402961 | Completed Phase 2

• 1 other identifier: 06-145
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Ileus; Colon Cancer; Pain, Postoperative; Postoperative Nausea and Vomiting

Keywords

Acupuncture; Post-Colectomy Ileus; Abdominal Surgery; Colon Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  end of study

Secondary Outcomes (7)

• To explore whether acupuncture improves patient satisfaction with the hospital experience by ameliorating other postoperative symptoms such as pain and nausea and vomiting

  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.

• To determine the feasibility of a Phase III trial in terms of sample size, accrual rate, attrition rate and data completion

  end of study

• GI-2, (also representing time to recovery of gastrointestinal [GI] function)

  patient first tolerated solid food,and time patient first passed a bowel movement

• GI contractions measured with a multifunctional stethoscope

  duration of two minute before and immediately after each true or sham acupuncture treatment.

• Daily pain score

  daily during hospitalization

Study Arms (2)

1

ACTIVE COMPARATOR

Acupuncture is the insertion of needles at certain body points.

Other: Acupuncture

2

SHAM COMPARATOR

sham acupuncture

Other: Sham Acupuncture

Interventions

Acupuncture OTHER

Acupuncture will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge.

1

Sham Acupuncture OTHER

Sham Acupuncture involves the acupuncturist tapping a plastic guiding tube on the surface of the true points to produce some discernible sensation and then immediately tapping a real needle sideways parallel to the skin surface without needle insertion. It will be given twice daily for a total of three days (Day 1 to 3). The two acupuncture sessions will be separated by at least 4 hours, preferably given in the morning and late afternoon. Each session will last approximately 30 minutes, starting from the moment the first needle is inserted and ending the moment the first needle is removed. The last treatment will be given at the end of Day 3 or day of discharge,

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center 1275 York Avenue

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Colonic Neoplasms; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Gary Deng, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2006
• First Posted: November 23, 2006
• Study Start: October 1, 2006
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

US (1)