Clinical trial · Interventional
Trial of Acupuncture for Reduction of Post-Colectomy Ileus
A Phase II Randomized Controlled Trial of Acupuncture for Reduction of Post-Colectomy Ileus
NCT00402961CI-TRIAL-00019424completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see whether acupuncture may help patients recover from colon cancer surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Pain, Postoperative | — | UNRESOLVED | — |
| Postoperative Ileus | — | UNRESOLVED | — |
| Postoperative Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Other | — | UNRESOLVED |
| Sham Acupuncture | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Acupuncture is the insertion of needles at certain body points.
- interventionNames
- Other: Acupuncture
- type
- SHAM_COMPARATOR
- label
- 2
- description
- sham acupuncture
- interventionNames
- Other: Sham Acupuncture
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.