Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02036268
Other study ID # 1202007926
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 2012
Est. completion date September 12, 2018

Study information

Verified date May 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized study of standard versus extra ostomy education.


Description:

The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.


Recruitment information / eligibility

Status Terminated
Enrollment 53
Est. completion date September 12, 2018
Est. primary completion date September 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Age equal to or greater than 18 years of age at the time of consent. - Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process. - Are willing and able to provide written informed consent for participation in the study and authorization for release of health information. - Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care. - Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy. - Subjects who do NOT have any history of prior colostomy or ileostomy. Exclusion Criteria: - Subjects not meeting any of the above eligibility criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard
Standard ostomy education
Pre-operative Education
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
Two-week Post Operative Education
In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.

Locations

Country Name City State
United States Indiana University Health North Hospital Carmel Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stoma Quality of Life Scale (SQOLS) The SQOLS assesses patient quality of life on a 5-point Likert type scale, where 1 = Never and 5 = Always. Higher scores indicate a greater self-reported quality of life. Six weeks
Secondary Skin integrity at the ostomy site by lesion type Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion type. Six weeks
Secondary Skin integrity at the ostomy site by location Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion location. Six weeks
Secondary Number of appliance changes Subjects will be asked to record the number of wafer and/or bag changes completed during study participation in a patient diary. Six weeks
Secondary Stoma Care Self-Efficacy Scale (SCSES) The SCSES assesses patient quality of life on a 4-point Likert type scale, where 1 = Not At All and 5 = Almost Always. Higher scores indicate a greater self-reported quality of life related to self-confidence in stoma care. Six weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Completed NCT01691729 - Comparison Study of 3 Ostomy Products N/A
Active, not recruiting NCT00391508 - Skin Problems in Ostomy Patients: An Epidemiological Study N/A
Recruiting NCT04943822 - The Effectiveness of APP Intervention on Home Self-care Ability and Quality of Life of Patients With Intestinal Stoma N/A
Recruiting NCT03715179 - Observational Study of Ostomy Consumers
Terminated NCT03057132 - Use of 3M Cavilon Advanced Skin Protectant in the Management of Damaged Skin Around an Ostomy, Drain or Fistula N/A
Recruiting NCT02319434 - Ostom-i Alert Sensor Quality of Life Validation
Not yet recruiting NCT06310070 - 3D Printed Personalized Ostomy Appliance N/A
Completed NCT02401412 - The Advocate Study N/A
Active, not recruiting NCT05745909 - Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy N/A
Completed NCT02889536 - Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences N/A
Recruiting NCT05796544 - Effectiveness of Remote Self-care Education for Ostomy Patients N/A
Completed NCT05573256 - Effects of Sleep Hygiene Education and Lavender Oil Inhalation on Sleep Quality, Fatigue, Quality of Life N/A
Terminated NCT02472639 - Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy N/A
Recruiting NCT04326335 - Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients N/A
Unknown status NCT01526967 - Observational Evaluation of the Peristomal Skin Condition in Ostomates N/A
Completed NCT04635215 - Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology
Recruiting NCT06213441 - Improving the Quality of Life and Self-sufficiency of Individuals With Stoma: Pecha Kucha Training Via Smartphone N/A
Completed NCT01261988 - Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteemâ„¢ Phase 1
Completed NCT04561674 - The Effect of Web-Based Patient Education on Quality of Life of Patients With Colostomy and Ileostomy N/A