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

NCT02639195 | Unknown

• 1 other identifier: SBO-C2015-005
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Bowel Obstruction; Quality of Life; Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Questionnaire based study for QOL changes over 90 days

  90 days

Study Arms (2)

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

Untreated control

Prospective data collection via questionnaire of subjects with a history of small bowel obstruction in an observational manner. No treatment is performed.

Interventions

Treatment OTHER

Retrospective chart review of patients treated with manual therapy.

Also known as: Manual Therapy

Treatment, retrospective

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Currently pregnant
• Cancer within the last 10 years
• Chemotherapy or radiation treatments within the last 10 years
• Prior treatment at Clear Passage

Sponsors & Collaborators

• Clear Passage Therapies, Inc: lead

Study Sites (1)

Clear Passage Physical Therapy

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

Therapeutics; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Study Officials

• Amanda Rice, PhD

  Clear Passage Therapies

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 24, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)