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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 : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Nina Elizabeth Glass, MD, Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE September 27, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Length of Stay [ Time Frame: 0-14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03662672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Time to first meal [ Time Frame: 0-14 days ]
  • Time to first flatus [ Time Frame: 0-14 days ]
  • Time to first bowel movement [ Time Frame: 0-14 days ]
  • Need for nasogastric tube postop [ Time Frame: 0-14 days ]
  • Nausea/vomiting postop [ Time Frame: 0-14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rib Raising for Post-operative Ileus
Official Title  ICMJE Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus
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%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Intestinal Pseudo-Obstruction
  • Manipulation, Osteopathic
  • Postoperative Care
  • Postoperative Nausea and Vomiting
  • Postoperative Complications
  • Osteopathic Medicine
Intervention  ICMJE
  • Procedure: Rib raising and lumbar release
    Rib raising per protocol described in arm description.
  • Procedure: Sham procedure
    Sham procedure per protocol described in arm description
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Rib raising and lumbar release
  • 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).
    Intervention: Procedure: Sham procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nina E Glass, MD 973-972-6293 nina.glass@rutgers.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662672
Other Study ID Numbers  ICMJE Pro2018001548
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nina Elizabeth Glass, MD, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rutgers, The State University of New Jersey
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP