Postoperative IleusNCT04713241
Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery
A study testing Electro-acupuncture in people with Postoperative Ileus and Gastrointestinal Cancer, run by Case Comprehensive Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Ileus, Gastrointestinal Cancer
- What is being tested?
- Electro-acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
Official title: A Feasibility Study of Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery
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.
Read the 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
- Conditions
- Postoperative Ileus, Gastrointestinal Cancer
- Being tested
- Electro-acupuncture, Standard of Care Bowel rest
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupunctureProcedure or surgery
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.
Standard of Care Bowel restOther
Bowel rest with NPO status and placement of nasogastric tube (NGT) if clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Group A: SOC | Active comparator | Participants will receive the SOC and will also be asked to complete questionnaires to rate their symptoms Receives: Other: Standard of Care Bowel rest |
| 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. Receives: Procedure: Electro-acupuncture; Other: Standard of Care Bowel rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: An average of 1 day post-treatment
Secondary outcomes (2)
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
Measured: An average of 1 day post-treatment
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
Measured: An average of 1 day post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study startJan 2022 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Lee, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713241
- Sponsor's protocol ID
- CASE3220
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT04713241
- Acronym / sponsor ID
- CASE3220
- Conditions
- Postoperative Ileus, Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: SOC | Active comparator | Other: Standard of Care Bowel restParticipants will receive the SOC and will also be asked to complete questionnaires to rate their symptoms |
| Group B: Electro-Acupuncture | Experimental | Procedure: Electro-acupuncture, Other: Standard of Care Bowel restParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-acupuncture20-30 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. | Procedure or surgery | Group B: Electro-Acupuncture |
| Standard of Care Bowel restBowel rest with NPO status and placement of nasogastric tube (NGT) if clinically indicated | Other | Group A: SOC, Group B: Electro-Acupuncture |
Primary outcome
Feasibility as measured by acceptance rate of participation in study
Time frame: An average of 1 day post-treatment
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
2 secondary outcomes
Time of ability to tolerate oral diet (liquid and solid food in hours)
Time frame: An average of 1 day post-treatment
Nasogastric tube (NG TB) output
Time frame: An average of 1 day post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Yes. 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
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At-Home Bowel Stimulation
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The Food Network Effect
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Lee, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Electro-acupuncture in people with Postoperative Ileus and Gastrointestinal Cancer, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by acceptance rate of participation in study (time frame: An average of 1 day post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.