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

• Conditions: Small Bowel Obstruction; Bowel Obstruction; Quality of Life
• Interventions: Other: Treatment

• Registration Number: NCT02639195
• Lead Sponsor: Clear Passage Therapies, Inc

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-24
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01
• Primary Completion: 2017-04
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment, retrospective	Treatment	Retrospective analysis on patients treated with manual physical therapy in quality of life outcomes as measured by pre and post treatment questionnaires. Chart review.

Primary Outcome Measures

Name	Time	Method
Quality of life	90 days	Questionnaire based study for QOL changes over 90 days

Trial Locations

Locations (1)

Clear Passage Physical Therapy; 🇺🇸 Gainesville, Florida, United States