Rib Raising for Post-operative Ileus

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT03662672
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 9.2

Study Details

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%.

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 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: Sep 27, 2018
• Actual Primary Completion Date: Aug 15, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Length of Stay [0-14 days]

Secondary Outcome Measures

1. Time to first meal [0-14 days]

2. Time to first flatus [0-14 days]

3. Time to first bowel movement [0-14 days]

4. Need for nasogastric tube postop [0-14 days]

5. Nausea/vomiting postop [0-14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Newark	New Jersey	United States	07103

Sponsors and Collaborators

• Rutgers, The State University of New Jersey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Nina Elizabeth Glass, MD, Assistant Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT03662672
• Other Study ID Numbers: Pro2018001548
• First Posted: Sep 7, 2018
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intestinal Pseudo-Obstruction; Vomiting; Postoperative Complications; Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Mar 10, 2022