CClinicalTrials.gg
Status unknownNCT02639195Updated Feb 1, 2017

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

An observational study in Small Bowel Obstruction, Quality of Life and Bowel Obstruction, sponsored by Clear Passage Therapies, Inc. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-02-01.

Sponsored by Clear Passage Therapies, Inc · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
350
Ages
18 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Small Bowel Obstruction
  • Quality of Life
  • Bowel Obstruction
03

In context

Intestinal Obstruction

160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.

This study's planned enrollment of 350 is above the median of 152 across 68 observational studies indexed under Intestinal Obstruction.

Browse Intestinal Obstruction studies →

Lead sponsor

Clear Passage Therapies, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Currently pregnant
  • Cancer within the last 10 years
  • Chemotherapy or radiation treatments within the last 10 years
  • Prior treatment at Clear Passage
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherTreatment

    Retrospective chart review of patients treated with manual therapy.

    Also known as: Manual Therapy

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What researchers measure

Primary outcomes

  1. Quality of life

    Questionnaire based study for QOL changes over 90 days

    Time frame: 90 days

07

Study locations

1 site
  • Clear Passage Physical Therapy
    Gainesville, Florida 32606, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02639195
Lead sponsor
Clear Passage Therapies, Inc
Responsible party
Lawrence Wurn (CEO, Clear Passage Therapies, Inc) — Principal investigator
First posted
Dec 24, 2015
Start date
Dec 2015
Primary completion
Apr 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Feb 1, 2017

Study contacts

Amanda Rice, PhD
study director · Clear Passage Therapies

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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