NCT03662672

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

September 27, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

September 5, 2018

Last Update Submit

March 8, 2022

Conditions

Intestinal Pseudo-ObstructionManipulation, OsteopathicPostoperative CarePostoperative Nausea and VomitingPostoperative ComplicationsOsteopathic Medicine

Outcome Measures

Primary Outcomes (1)

  • Length of Stay

    0-14 days

Secondary Outcomes (5)

  • 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

Study Arms (2)

Rib-raising Intervention

EXPERIMENTAL

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

Sham Intervention

SHAM COMPARATOR

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

Interventions

Rib raising and lumbar releasePROCEDURE

Rib raising per protocol described in arm description.

Rib-raising Intervention
Sham procedurePROCEDURE

Sham procedure per protocol described in arm description

Sham Intervention

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

Related 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.

    PMID: 23485980BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Intestinal Pseudo-ObstructionPostoperative Nausea and VomitingPostoperative Complications

Condition Hierarchy (Ancestors)

IleusIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 7, 2018

Study Start

September 27, 2018

Primary Completion

August 15, 2019

Study Completion

August 30, 2019

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

US(1)