Trial of Acupuncture for Reduction of Post-Colectomy Ileus

Phase 2

Completed

• Conditions: Colon Cancer; Postoperative Ileus; Postoperative Nausea and Vomiting; Pain, Postoperative
• Interventions: Other: Sham Acupuncture; Other: Acupuncture

• Registration Number: NCT00402961
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Sham Acupuncture	sham acupuncture
1	Acupuncture	Acupuncture is the insertion of needles at certain body points.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Daily pain score	daily during hospitalization
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.
Opioid consumption (total dose of morphine equivalent during hospitalization and average dose per day)	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 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
Number of emetic episodes during hospital stay	assement daily

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center 1275 York Avenue; 🇺🇸 New York, New York, United States