The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL)

NCT ID: NCT02639195

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Small Bowel Obstruction Quality of Life Bowel Obstruction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Treatment

Intervention Type OTHER

Retrospective chart review of patients treated with manual therapy.

Untreated control

Prospective data collection via questionnaire of subjects with a history of small bowel obstruction in an observational manner. No treatment is performed.

No interventions assigned to this group

Interventions

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Treatment

Retrospective chart review of patients treated with manual therapy.

Intervention Type OTHER

Other Intervention Names

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Manual Therapy

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Currently pregnant
* Cancer within the last 10 years
* Chemotherapy or radiation treatments within the last 10 years
* Prior treatment at Clear Passage
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clear Passage Therapies, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Lawrence Wurn

CEO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda Rice, PhD

Role: STUDY_DIRECTOR

Clear Passage Therapies

Locations

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Clear Passage Physical Therapy

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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SBO-C2015-005

Identifier Type: -

Identifier Source: org_study_id

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