Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT00402961
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00402961
Study Brief:
Protocol Section:
NCT00402961