Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastrointestinal Cancer; Postoperative Ileus
• Intervention / Treatment: Other: Standard of Care Bowel rest; Procedure: Electro-acupuncture

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group A: SOC; Participants will receive the SOC and will also be asked to complete questionnaires to rate their symptoms	Other: Standard of Care Bowel rest; Bowel rest with NPO status and placement of nasogastric tube (NGT) if clinically indicated
EXPERIMENTAL: Group B: Electro-Acupuncture; 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.	Other: Standard of Care Bowel rest; Bowel rest with NPO status and placement of nasogastric tube (NGT) if clinically indicated; Procedure: Electro-acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Richard Lee, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Gastrointestinal Neoplasms; Ileus
• Other Study ID Numbers: CASE3220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No