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Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery

Primary Purpose

Postoperative Ileus, Gastrointestinal Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Electro-acupuncture

Standard of Care Bowel rest

About this trial

This is an interventional supportive care trial for Postoperative Ileus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: SOC

Group B: Electro-Acupuncture

Arm Description

Participants will receive the SOC and will also be asked to complete questionnaires to rate their symptoms

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT04713241

First Posted

January 14, 2021

Last Updated

March 2, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT04713241

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Withdrawn

Why Stopped

PI left

Study Start Date

January 2022 (Anticipated)

Primary Completion Date

March 2022 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Ileus, Gastrointestinal Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: SOC

Arm Type

Active Comparator

Arm Description

Participants will receive the SOC and will also be asked to complete questionnaires to rate their symptoms

Arm Title

Group B: Electro-Acupuncture

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Electro-acupuncture

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard of Care Bowel rest

Intervention Description

Bowel rest with NPO status and placement of nasogastric tube (NGT) if clinically indicated

Primary Outcome Measure Information:

Title

Feasibility as measured by acceptance rate of participation in study

Description

Time Frame

An average of 1 day post-treatment

Secondary Outcome Measure Information:

Title

Time of ability to tolerate oral diet (liquid and solid food in hours)

Description

Time Frame

An average of 1 day post-treatment

Title

Nasogastric tube (NG TB) output

Description

Time Frame

An average of 1 day post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Lee, MD

Organizational Affiliation

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Learn more about this trial

Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery

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