Rib Raising for Post-operative Ileus

Study Overview
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Brief Summary
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We are conducting a randomized controlled trial the use of rib raising for post-operative ileus. Rib raising is an osteopathic manipulative technique (OMT). We will recruit all patients undergoing major abdominal surgery and once they have been enrolled, we will randomize them to receive daily rib raising or a control technique where we place hands on the back but do not apply any pressure. In preliminary studies, Rib raising has been shown to reduce post-operative ileus and hospital length of stay by up to 50%.

Official Title
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Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus

Conditions
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Intestinal Pseudo-Obstruction, Manipulation, Osteopathic, Postoperative Care, Postoperative Nausea and Vomiting, Postoperative Complications, Osteopathic Medicine

Intervention / Treatment
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* Procedure: Rib raising and lumbar release
* Procedure: Sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy) Exclusion Criteria: Open abdomen for >72 hours Prior history of major post-operative complications Intolerance to anesthesia Co-morbidities including osteoporosis and osteopenia Spine or rib fractures Pregnancy Prisoners History of osteopathic manipulation Recruitment delayed beyond 48 hours Surgeon requested exclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rib-raising Intervention<br>We will do daily rib raising and lumbar release from the 5th thoracic vertebra to the 2nd lumbar vertebra for 2 minutes per side for rib raising and 2 minutes for lumbar release. | Procedure: Rib raising and lumbar release<br>* Rib raising per protocol described in arm description.<br>|
| Sham Comparator: Sham Intervention<br>We will do daily sham intervention from the 5th thoracic vertebra to the 2nd lumbar vertebra where we place our hands under the ribs for 2 minutes per side and under the lumbar area for 2 minutes without applying any pressure (or applying pressure into the bed). | Procedure: Sham procedure<br>* Sham procedure per protocol described in arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay |  | 0-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first meal |  | 0-14 days | 
| Time to first flatus |  | 0-14 days | 
| Time to first bowel movement |  | 0-14 days | 
| Need for nasogastric tube postop |  | 0-14 days | 
| Nausea/vomiting postop |  | 0-14 days |