Trial of Acupuncture for Reduction of Post-Colectomy Ileus

Pain, Postoperative Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

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

• NCT number: NCT00402961
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Completion date: February 2013