Status:
WITHDRAWN
Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Postoperative Ileus
Gastrointestinal Cancer
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The goal of this study is to learn if electro-acupuncture is a feasible treatment option for postoperative ileus after abdominal surgery. The second goal of this study is to evaluate the time to resol...
Detailed Description
Postoperative ileus is one of the most common complications following abdominal surgery. Despite significant advances in prevention, postoperative ileus continues to be a clinical issue. For patients ...
Eligibility Criteria
Inclusion
- Must have the ability to understand and sign a written informed consent document, and be willing to follow protocol requirements
- Diagnosis of gastrointestinal cancer
- Bowel resection was performed via an open or laparoscopic approach
- Diagnosis of POI defined as one or more of the following criteria: 1) return to NPO status after initial attempts at oral diet, and/or 2) need for placement of nasogastric tube after surgery.
- Willingness to comply with all study interventions of acupuncture
Exclusion
- Active Infection at or near the acupuncture site or systemic infection (e.g. sepsis)
- Physical deformities that could interfere with accurate acupuncture and point location
- Concurrent use of other alternative medicines such as herbal agents and high dose vitamins and minerals
- Known coagulopathy or taking heparin (including low molecular weight heparin) at full anti-coagulation doses (prophylaxis is allowed) or Coumadin at any dose. Patients on aspirin or non-steroidal anti-inflammatories or other antiplatelet medicines will be allowed to participate
- Platelets \<50 H K/UL in the past 30 days
- White Blood Cells (WBCs) \<3.0 K/UL or Absolute Neutrophil Count (ANC) \<1500 K/UL in the past 30 days
- INR \>5 in the past 30 days
- Liver failure defined as liver function test \>5x upper limit of normal
- Implanted electrical device such as a cardiac pacemaker, insulin pump or pain pump
- Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry
- Previous acupuncture treatment for any indications within 30 days of enrollment
- Currently pregnant
- Grade III lymphedema/lymphedema considered severe by the treating clinician
- Chronic daily opioid use prior to admission
- Enrollment in another surgical clinical trial
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04713241
Start Date
January 1 2022
End Date
March 1 2023
Last Update
March 17 2022
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