Intestinal Pseudo-ObstructionNCT03662672
Rib Raising for Post-operative Ileus
A study testing Rib raising and lumbar release in people with Intestinal Pseudo-Obstruction and Manipulation, Osteopathic, run by Rutgers, The State University of New Jersey at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Intestinal Pseudo-Obstruction, Manipulation, Osteopathic, Postoperative Care
- What is being tested?
- Rib raising and lumbar release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)
Who cannot join
- 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
Show all 10Show fewer
- Prisoners
- History of osteopathic manipulation
- Recruitment delayed beyond 48 hours
- Surgeon requested exclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Rib Raising as Early Treatment 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%.
- Conditions
- Intestinal Pseudo-Obstruction, Manipulation, Osteopathic, Postoperative Care, Postoperative Nausea and Vomiting, Postoperative Complications, Osteopathic Medicine
- Being tested
- Rib raising and lumbar release, Sham procedure
- Medical subject headings
- Intestinal Pseudo-Obstruction, Postoperative Nausea and Vomiting, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rib raising and lumbar releaseProcedure or surgery
Rib raising per protocol described in arm description.
Sham procedureProcedure or surgery
Sham procedure per protocol described in arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Measured: 0-14 days
Secondary outcomes (5)
Time to first meal
Measured: 0-14 days
Time to first flatus
Measured: 0-14 days
Time to first bowel movement
Measured: 0-14 days
Need for nasogastric tube postop
Measured: 0-14 days
Nausea/vomiting postop
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start27 Sep 2018
- Primary completion15 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal Pseudo-ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Elizabeth Glass, MD, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662672
- Sponsor's protocol ID
- Pro2018001548
- Status last verified
- Mar 2022
- First submitted
- 5 Sep 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23485980Crow 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Rib Raising as Early Treatment for Post-operative Ileus
- ClinicalTrials.gov ID
- NCT03662672
- Acronym / sponsor ID
- Pro2018001548
- Conditions
- Intestinal Pseudo-Obstruction, Manipulation, Osteopathic, Postoperative Care, Postoperative Nausea and Vomiting, Postoperative Complications, Osteopathic Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rib-raising Intervention | Experimental | Procedure: Rib raising and lumbar releaseWe 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. |
| Sham Intervention | Sham comparator | Procedure: Sham procedureWe 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). |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major abdominal surgery (laparotomy, laparoscopy excluding simple laparoscopic appendectomy or laparoscopic cholecystectomy)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rib raising and lumbar releaseRib raising per protocol described in arm description. | Procedure or surgery | Rib-raising Intervention |
| Sham procedureSham procedure per protocol described in arm description | Procedure or surgery | Sham Intervention |
Primary outcome
Length of Stay
Time frame: 0-14 days
5 secondary outcomes
Time to first meal
Time frame: 0-14 days
Time to first flatus
Time frame: 0-14 days
Time to first bowel movement
Time frame: 0-14 days
Need for nasogastric tube postop
Time frame: 0-14 days
Nausea/vomiting postop
Time frame: 0-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 23485980Baltazar 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.
- BackgroundCrow 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.
- BackgroundHerrmann EP. Postoperative adynamic ileus: its prevention and treatment by osteopathic manipulation. The DO. 1965;6(2):163-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rib raising and lumbar release in people with Intestinal Pseudo-Obstruction and Manipulation, Osteopathic, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: 0-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03662672, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.