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Rib Raising for Post-operative Ileus

Primary Purpose

Intestinal Pseudo-Obstruction, Manipulation, Osteopathic, Postoperative Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rib raising and lumbar release
Sham procedure
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Pseudo-Obstruction

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Rib-raising Intervention

Sham Intervention

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Length of Stay

Secondary Outcome Measures

Time to first meal
Time to first flatus
Time to first bowel movement
Need for nasogastric tube postop
Nausea/vomiting postop

Full Information

First Posted
September 5, 2018
Last Updated
March 8, 2022
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT03662672
Brief Title
Rib Raising for Post-operative Ileus
Official Title
Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Pseudo-Obstruction, Manipulation, Osteopathic, Postoperative Care, Postoperative Nausea and Vomiting, Postoperative Complications, Osteopathic Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rib-raising Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Intervention
Arm Type
Sham Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Rib raising and lumbar release
Intervention Description
Rib raising per protocol described in arm description.
Intervention Type
Procedure
Intervention Name(s)
Sham procedure
Intervention Description
Sham procedure per protocol described in arm description
Primary Outcome Measure Information:
Title
Length of Stay
Time Frame
0-14 days
Secondary Outcome Measure Information:
Title
Time to first meal
Time Frame
0-14 days
Title
Time to first flatus
Time Frame
0-14 days
Title
Time to first bowel movement
Time Frame
0-14 days
Title
Need for nasogastric tube postop
Time Frame
0-14 days
Title
Nausea/vomiting postop
Time Frame
0-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23485980
Citation
Baltazar GA, Betler MP, Akella K, Khatri R, Asaro R, Chendrasekhar A. Effect of osteopathic manipulative treatment on incidence of postoperative ileus and hospital length of stay in general surgical patients. J Am Osteopath Assoc. 2013 Mar;113(3):204-9. Erratum In: J Am Osteopath Assoc. 2013 Apr;113(4):271.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Herrmann EP. Postoperative adynamic ileus: its prevention and treatment by osteopathic manipulation. The DO. 1965;6(2):163-4.
Results Reference
background

Learn more about this trial

Rib Raising for Post-operative Ileus

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