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

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ClinicalTrials.gov Identifier: NCT02639195
Recruitment Status : Unknown
Verified January 2017 by Lawrence Wurn, Clear Passage Therapies, Inc.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2015
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Lawrence Wurn, Clear Passage Therapies, Inc

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Small Bowel Obstruction Quality of Life Bowel Obstruction Other: Treatment

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
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : December 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Treatment
Retrospective chart review of patients treated with manual therapy.
Other Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: 90 days ]
    Questionnaire based study for QOL changes over 90 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Population with a history of a bowel obstruction in the last 2 years.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639195


Locations
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United States, Florida
Clear Passage Physical Therapy
Gainesville, Florida, United States, 32606
Sponsors and Collaborators
Clear Passage Therapies, Inc
Investigators
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Study Director: Amanda Rice, PhD Clear Passage Therapies
More Information
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Responsible Party: Lawrence Wurn, CEO, Clear Passage Therapies, Inc
ClinicalTrials.gov Identifier: NCT02639195    
Other Study ID Numbers: SBO-C2015-005
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases