Clinical trial NCT02639195: The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL)
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Bowel Obstruction
Quality of Life
Bowel Obstruction
Lead sponsor: Clear Passage Therapies, Inc
Sponsor class: INDUSTRY
First posted: 2015-12-24
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population with a history of a bowel obstruction in the last 2 years.

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.

Eligibility 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

Primary outcomes:
measure: Quality of life
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Clear Passage Physical Therapy
state: Florida
Study officials:
affiliation: Clear Passage Therapies
name: Amanda Rice, PhD
role: STUDY_DIRECTOR
References: