Small Bowel ObstructionNCT02639195
The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL)
An observational study of Small Bowel Obstruction and Quality of Life, run by Clear Passage Therapies, Inc at 1 site in United States.
Trial summary
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Small Bowel Obstruction, Quality of Life, Bowel Obstruction
- What is being tested?
- Treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2017
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population with a history of a bowel obstruction in the last 2 years.
Who may be able to join
- Age between 18 and 90 years old
- Previous diagnosis of partial or total bowel obstruction in the last 2 years.
- Able to complete the questionnaire online via Assessment Center.
Who cannot join
- Currently pregnant
- Cancer within the last 10 years
- Chemotherapy or radiation treatments within the last 10 years
- Prior treatment at Clear Passage
Trial locations and contacts
1 site in 1 country.
United States1 site
Clear Passage Physical Therapy
Gainesville, Florida, 32606
About this study
Official title: The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL); the Efficacy of a Manual Physical Therapy to Improve QOL in Subjects With a History of SBO
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the internet. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.
Read the detailed description
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the Assessment Center. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.
- Conditions
- Small Bowel Obstruction, Quality of Life, Bowel Obstruction
- Being tested
- Treatment
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
Also called Manual Therapy
Retrospective chart review of patients treated with manual therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment, retrospective | Retrospective analysis on patients treated with manual physical therapy in quality of life outcomes as measured by pre and post treatment questionnaires. Chart review. Receives: Other: Treatment | |
| Untreated control | Prospective data collection via questionnaire of subjects with a history of small bowel obstruction in an observational manner. No treatment is performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Questionnaire based study for QOL changes over 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clear Passage Therapies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Lawrence Wurn, Clear Passage Therapies, Inc
- Investigators
- Amanda Rice, PhD, Study director, Clear Passage Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639195
- Sponsor's protocol ID
- SBO-C2015-005
- Status last verified
- Jan 2017
- First submitted
- 21 Dec 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL); the Efficacy of a Manual Physical Therapy to Improve QOL in Subjects With a History of SBO
- ClinicalTrials.gov ID
- NCT02639195
- Acronym / sponsor ID
- SBO-C2015-005
- Conditions
- Small Bowel Obstruction, Quality of Life, Bowel Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Clear Passage Therapies, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- 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.
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the internet. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.
Detailed description
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the Assessment Center. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment, retrospective | – | Other: TreatmentRetrospective analysis on patients treated with manual physical therapy in quality of life outcomes as measured by pre and post treatment questionnaires. Chart review. |
| Untreated control | – | –Prospective data collection via questionnaire of subjects with a history of small bowel obstruction in an observational manner. No treatment is performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population with a history of a bowel obstruction in the last 2 years.
Key inclusion criteria (3 listed)
- Age between 18 and 90 years old
- Previous diagnosis of partial or total bowel obstruction in the last 2 years.
- Able to complete the questionnaire online via Assessment Center.
Key exclusion criteria (4 listed)
- Currently pregnant
- Cancer within the last 10 years
- Chemotherapy or radiation treatments within the last 10 years
- Prior treatment at Clear Passage
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 |
|---|---|---|
| TreatmentAlso: Manual TherapyRetrospective chart review of patients treated with manual therapy. | Other | Treatment, retrospective |
Primary outcome
Quality of life
Time frame: 90 days
Questionnaire based study for QOL changes over 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- 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.
Amanda Rice, PhD study director
Clear Passage Therapies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Obstruction and Quality of Life, run by Clear Passage Therapies, Inc 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2017. 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. 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?
Results are not available in the source record.
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?
Quality of life (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2017.