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Completed

NCT Number: NCT03662672

Rib Raising 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%.

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Key information

Conditions

Intestinal Pseudo-Obstruction Digestive System Diseases Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction Manipulation, Osteopathic Nausea Osteopathic Medicine Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Care Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Newark, New Jersey, 07103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rib raising and lumbar release

Procedure

Rib raising per protocol described in arm description.

Sham Procedure

Procedure

Sham procedure per protocol described in arm description

Primary outcomes

  1. Length of Stay

    Time frame: 0-14 days

Secondary outcomes

  1. Time to first meal

    Time frame: 0-14 days

  2. Time to first flatus

    Time frame: 0-14 days

  3. Time to first bowel movement

    Time frame: 0-14 days

  4. Need for nasogastric tube postop

    Time frame: 0-14 days

  5. Nausea/vomiting postop

    Time frame: 0-14 days

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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