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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02639195
• Other study ID #: SBO-C2015-005
• Status: Active, not recruiting
• Phase: N/A
• First received: December 21, 2015
• Last updated: January 30, 2017
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Clear Passage Therapies, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Obstruction
• Intestinal Obstruction
• Quality of Life
• Small Bowel Obstruction

Intervention

Other:
• Treatment
Retrospective chart review of patients treated with manual therapy.

Locations

Country	Name	City	State
United States	Clear Passage Physical Therapy	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Clear Passage Therapies, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Questionnaire based study for QOL changes over 90 days	90 days