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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02639195
Enrollment
350
Registered
2015-12-24
Start date
2015-12-31
Completion date
2017-12-31
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Obstruction, Quality of Life, Small Bowel Obstruction

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.

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.

Interventions

OTHERTreatment

Retrospective chart review of patients treated with manual therapy.

Sponsors

Clear Passage Therapies, Inc
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life90 daysQuestionnaire based study for QOL changes over 90 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026