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Rib Raising for Post-operative Ileus

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ClinicalTrials.gov Identifier: NCT03662672
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nina Elizabeth Glass, MD, Rutgers, The State University of New Jersey

Brief Summary:
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%.

Condition or disease Intervention/treatment Phase
Intestinal Pseudo-Obstruction Manipulation, Osteopathic Postoperative Care Postoperative Nausea and Vomiting Postoperative Complications Osteopathic Medicine Procedure: Rib raising and lumbar release Procedure: Sham procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: Rib-raising Intervention
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
Rib raising per protocol described in arm description.

Sham Comparator: Sham Intervention
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
Sham procedure per protocol described in arm description




Primary Outcome Measures :
  1. Length of Stay [ Time Frame: 0-14 days ]

Secondary Outcome Measures :
  1. Time to first meal [ Time Frame: 0-14 days ]
  2. Time to first flatus [ Time Frame: 0-14 days ]
  3. Time to first bowel movement [ Time Frame: 0-14 days ]
  4. Need for nasogastric tube postop [ Time Frame: 0-14 days ]
  5. Nausea/vomiting postop [ Time Frame: 0-14 days ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662672


Contacts
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Contact: Nina E Glass, MD 973-972-6293 nina.glass@rutgers.edu

Locations
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United States, New Jersey
University Hospital Recruiting
Newark, New Jersey, United States, 07103
Contact: Nina E Glass, MD         
Sponsors and Collaborators
Rutgers, The State University of New Jersey

Publications:
Crow WT, Gorodinsky L. Does osteopathic manipulative treatment (OMT) improves outcomes in patients who develop postoperative ileus: A retrospective chart review. International Journal of Osteopathic Medicine. 2009;12(1):32-7.
Herrmann EP. Postoperative adynamic ileus: its prevention and treatment by osteopathic manipulation. The DO. 1965;6(2):163-4.

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Responsible Party: Nina Elizabeth Glass, MD, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03662672     History of Changes
Other Study ID Numbers: Pro2018001548
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Postoperative Complications
Intestinal Pseudo-Obstruction
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases