Acupuncture for the Treatment of Postoperative Ileus After Gastrointestinal Surgery

NCT04713241 | Withdrawn

• 1 other identifier: CASE3220
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Ileus; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  An average of 1 day post-treatment

• Nasogastric tube (NG TB) output

  An average of 1 day post-treatment

Study Arms (2)

Group A: SOC

ACTIVE COMPARATOR

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

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.

Procedure: Electro-acupuncture; Other: Standard of Care Bowel rest

Interventions

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.

Group B: Electro-Acupuncture

Standard of Care Bowel rest OTHER

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

Group A: SOC; Group B: Electro-Acupuncture

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Richard Lee, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: January 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share