Rib Raising for Post-operative Ileus

NCT ID: NCT03662672

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2019-08-30

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%.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rib raising and lumbar release

Intervention Type: PROCEDURE

Rib raising per protocol described in arm description.

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).

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: PROCEDURE

Sham procedure per protocol described in arm description

Interventions

Rib raising and lumbar release

Rib raising per protocol described in arm description.

Intervention Type: PROCEDURE

Sham procedure

Sham procedure per protocol described in arm description

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Nina Elizabeth Glass, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital

Newark, New Jersey, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23485980 (View on PubMed)

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

Pro2018001548

Identifier Type: -

Identifier Source: org_study_id