Rib Raising for Post-operative Ileus

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662672
• Other study ID #: Pro2018001548
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: March 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 30, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Pseudo-Obstruction
• Manipulation, Osteopathic
• Osteopathic Medicine
• Postoperative Care
• Postoperative Complications
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Procedure:
• Rib raising and lumbar release
Rib raising per protocol described in arm description.
• Sham procedure
Sham procedure per protocol described in arm description

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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.

Herrmann EP. Postoperative adynamic ileus: its prevention and treatment by osteopathic manipulation. The DO. 1965;6(2):163-4.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Stay		0-14 days
Secondary	Time to first meal		0-14 days
Secondary	Time to first flatus		0-14 days
Secondary	Time to first bowel movement		0-14 days
Secondary	Need for nasogastric tube postop		0-14 days
Secondary	Nausea/vomiting postop		0-14 days