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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Bowel Obstruction; Small Bowel Obstruction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32606
      • Clear Passage Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Population with a history of a bowel obstruction in the last 2 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Questionnaire based study for QOL changes over 90 days	90 days

Collaborators and Investigators

• Sponsor: Clear Passage Therapies, Inc
• Investigators: Study Director: Amanda Rice, PhD, Clear Passage Therapies

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 24, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: SBO-C2015-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED