Rib Raising for Post-operative Ileus

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

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%.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Nausea and Vomiting; Postoperative Care; Intestinal Pseudo-Obstruction; Osteopathic Medicine; Manipulation, Osteopathic
• Intervention / Treatment: Procedure: Rib raising and lumbar release; Procedure: Sham procedure

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of Stay	0-14 days

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): August 15, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Nausea; Ileus; Vomiting; Postoperative Complications; Postoperative Nausea and Vomiting; Intestinal Pseudo-Obstruction
• Other Study ID Numbers: Pro2018001548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No