Clinical trial NCT04713241: Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery
Official title: A Feasibility Study of Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Ileus
Gastrointestinal Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 resolution of postoperative ileus after receiving electro-acupuncture treatments.

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 experiencing postoperative ileus after a bowel resection, current treatment includes bowel rest, reduction of oral diet, and possible nasogastric tube placement while waiting for the postoperative ileus to resolve. Postoperative ileus results in postoperative complications, discomfort, and increases hospital stay. Electro-acupuncture treatment could potentially expedite the return of bowel function, reducing length of stay and increasing comfort. Additionally, acupuncture has been shown to be helpful for pain and nausea management, and thus may reduce the need for opioid and anti-nausea medications.

This study includes two groups. Both groups will be treated with conservative standard care (SOC), including bowel rest with nothing by mouth (NPO) status and placement of nasogastric tube if clinically necessary. Participants in both groups will continue on SOC postoperative recovery care with early feeding and ambulation, along with minimizing opioid use.

Group A: Participants assigned to group A will receive the SOC treatment described above and will also be asked to complete questionnaires to rate their symptoms.

Group B: Participants assigned to group B will receive the SOC described above and be given a daily 20-30 minute acupuncture treatment from the time of randomization until the return

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Feasibility as measured by acceptance rate of participation in study
timeFrame: An average of 1 day post-treatment
Secondary outcomes:
measure: Time of ability to tolerate oral diet (liquid and solid food in hours)
timeFrame: An average of 1 day post-treatment
measure: Nasogastric tube (NG TB) output
timeFrame: An average of 1 day post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Richard Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: