Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PI left
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: SOC | Active Comparator | Participants will receive the SOC and will also be asked to complete questionnaires to rate their symptoms |
|
| Group B: Electro-Acupuncture | Experimental | Participants will receive the SOC + a daily 20-30 minute electro-acupuncture treatment from the time of randomization until the return of bowel function. The first treatment will be provided within 48 hours after the diagnosis of postoperative ileus. Participants will receive acupuncture every day until normal bowel movement function returns. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-acupuncture | Procedure | 20-30 minute acupuncture treatment in sessions from start of study (within 48 hours of diagnosis) to return of bowel functions A practitioner stimulates certain points on the body by placing thin needles in the skin. Electrical stimulation is then added to some of the needles. This involves placing wires on the needles, which are connected to a machine that delivers a weak electrical current through the wires. The strength of the electrical current will be changed slowly until it is at a comfortable level. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as measured by acceptance rate of participation in study | Feasibility of acupuncture in study group as measured by acceptance rate of participation in study. Acceptance rate greater than 50% of patients being willing to participate will be considered feasible | An average of 1 day post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time of ability to tolerate oral diet (liquid and solid food in hours) | Time to resolution of Postoperative ileus (POI) as measured by time of ability to tolerate oral diet (liquid and solid food in hours) Reported in mean, standard deviation as well as the five number summary including the 25th, 50th, and 75th percentiles, the minimum and maximum values | An average of 1 day post-treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Lee, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
Not provided
Individual participant data will be shared upon request to members of the general public and scientific community at the conclusion and publication of the study results
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care Bowel rest | Other | Bowel rest with NPO status and placement of nasogastric tube (NGT) if clinically indicated |
|
| Nasogastric tube (NG TB) output | NG tube output, defined as volume of fluid collected from the NG TB Reported in mean, standard deviation as well as the five number summary including the 25th, 50th, and 75th percentiles, the minimum and maximum values | An average of 1 day post-treatment |
| D005767 |
| Gastrointestinal Diseases |