Acupuncture and Post-Operative Ileus
Primary Purpose
Ileus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional prevention trial for Ileus focused on measuring acupuncture, colon surgery, post operative ileus, post ileus, ileus, colectomy, colorectal pathology
Eligibility Criteria
Inclusion Criteria:
- male or female
- age 18-89
- colorectal pathology requiring standard elective open or laparoscopic colectomy
Exclusion Criteria:
- pregnancy
- pacemaker or implantable electronic devices
- bowel obstruction
- intra-abdominal abscess or sepsis
- colorectal tumors invading other organs or surrounding tissues
- diverticulitis complicated by fistula
- known immunodeficiency disorders
- tumors requiring an anastomosis below 7cm above the anal verge as measured by rigid proctosigmoidoscope exam at surgery
- chronic pain medications
- surgeries requiring temporary or permanent ostomies
- emergent operations
- receiving preoperative radiation/chemotherapy
- major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupunctural treatment areas
Sites / Locations
- Mayo Clinic
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
1
2
Arm Description
Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
Outcomes
Primary Outcome Measures
Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery.
Secondary Outcome Measures
Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon
Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication
Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655317
Brief Title
Acupuncture and Post-Operative Ileus
Official Title
Acupuncture and Post-Operative Ileus: A Prospective Randomized Study to Evaluate the Effects of Electrostimulated Acupuncture on Recovery From Ileus Following Standard Elective Colon Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postoperative ileus, the transient cessation of normal bowel function, is a universal aspect of colon surgery. Its occurrence may lead to increased patient discomfort and additional time and cost to hospital stay. Evidence from previous studies indicate that acupuncture may be beneficial in decreasing time to recovery of bowel function and decrease the body's inflammatory response. However, this has not been studied in a randomized, prospective fashion in colon surgery. The goal of this study is to determine if acupuncture may be utilized as a therapeutic modality to decrease time to return of bowel function and discharge from the hospital.
Detailed Description
The pathogenesis of post-operative ileus is not completely known. It is thought that post-operative ileus involves trauma to the bowel. This traumatizing of the intestine and peritoneal surfaces results in production and release of inflammatory mediators. These in turn, lead to inactivation of inhibitory neural reflexes. There is also an additive effect of opioids used for post-operative pain, aggravating and adding to the duration of post-operative ileus. Acupuncture has shown promise in both human and animal model studies to reduce post-operative nausea and vomiting and post-operative ileus. It is the investigator's hypothesis that acupuncture will minimize or reduce both post-operative ileus and nausea following elective colon surgery and will lead to a decrease in inflammatory markers that are known to be elevated following abdominal surgery.
The study goals are to determine if acupuncture:
Leads to earlier return of bowel function
Leads to earlier time to discharge following colon surgery
Leads to earlier return of colonic motility
Leads to decreased postoperative nausea and vomiting
Leads to a decrease in inflammation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
acupuncture, colon surgery, post operative ileus, post ileus, ileus, colectomy, colorectal pathology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Treatment Acupuncture Group (Therapeutic Acupuncture Treatment): treatment with actual acupuncture needles
Arm Title
2
Arm Type
Sham Comparator
Arm Description
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Treatment acupuncture group: therapeutic acupuncture treatment with actual needles
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
SHAM (control) acupuncture group: non-therapeutic acupuncture treatment
Primary Outcome Measure Information:
Title
Determine if acupuncture leads to earlier return of bowel function and earlier time to discharge following colon surgery.
Time Frame
Randomized acupuncture will be performed within 24 hours of completion of standard elective colon surgery
Secondary Outcome Measure Information:
Title
Acupuncture will lead to decreased time to return of colonic motility, as measured by earlier progression of radiological markers through the colon
Time Frame
radiological markers will be given preoperatively and then will be tracked via abdominal x-rays postoperatively
Title
Acupuncture will lead to decreased postoperative nausea and vomiting, resulting in less requirement of antiemetic medication
Time Frame
number of doses of antiemetic meds and number of episodes of vomiting and nausea will be recorded postoperatively
Title
Acupuncture will blunt the inflammatory response, which is associated with development of postoperative ileus
Time Frame
serum inflammatory markers will be measured preoperatively and postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female
age 18-89
colorectal pathology requiring standard elective open or laparoscopic colectomy
Exclusion Criteria:
pregnancy
pacemaker or implantable electronic devices
bowel obstruction
intra-abdominal abscess or sepsis
colorectal tumors invading other organs or surrounding tissues
diverticulitis complicated by fistula
known immunodeficiency disorders
tumors requiring an anastomosis below 7cm above the anal verge as measured by rigid proctosigmoidoscope exam at surgery
chronic pain medications
surgeries requiring temporary or permanent ostomies
emergent operations
receiving preoperative radiation/chemotherapy
major deformities of the upper or lower extremities and/or any active skin lesions or ulcers in acupunctural treatment areas
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip P. Metzger, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Acupuncture and Post-Operative Ileus
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