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出境医 / 临床实验 / Educational Program for Ostomy Patients (Ostomeducat) (ostomeducat)

Educational Program for Ostomy Patients (Ostomeducat) (ostomeducat)

Study Description
Brief Summary:
Stoma surgery is a relatively common treatment for patients suffering from colorectal diseases.This study aimed to investigate the impact on hospital stay and short-term overall complications prior to and following the introduction of an outpatient preoperative stoma education program.

Condition or disease Intervention/treatment Phase
Educational Problems Colostomy Complications Surgery Colorectal Disorders Other: Preoperative education Other: Postoperative education Not Applicable

Detailed Description:
38 patients undergoing stoma surgery were analyzed, 73 prior education program and 65 following it.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Study to Assess the Impact of an Educational Program for Ostomy Patients (Ostomeducat)
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015
Arms and Interventions
Arm Intervention/treatment
Preoperative education
Each patient had individual consultation several days before surgery with the stoma nurse specialist, following standard ostomy teaching plans
 Other: Preoperative education
65 patients were instructed to a preoperative stoma-education program

Other: Postoperative education
73 patients, receiving the same information in postoperative period.
Postoperative education
Each patient had individual consultationseveral days before surgery with the stoma nurse specialist, following standard ostomy teaching plans
 Other: Preoperative education
65 patients were instructed to a preoperative stoma-education program

Other: Postoperative education
73 patients, receiving the same information in postoperative period.
Outcome Measures
Primary Outcome Measures :
  1. Rate of.complications [ Time Frame: First 30 days after surgery ]
    Surgical complications

  2. Rate of mortality (assessed by Clavien-Dindo Classification) [ Time Frame: First 30 days after surgery ]
    Patient mortality within the first 30 days after surgery


Secondary Outcome Measures :
  1. Rate of readmissions [ Time Frame: the first 30 days after surgery ]
    Number of patient hospitalization within the first 30 days after surgery

  2. Reinterventions [ Time Frame: 30 days after surgery ]
    Patient new surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years of age undergoing elective colorectal resections that eventually would require formation of a stoma (colorectal cancer up to 20 cm from the anal verge, colonic poliposis and inflammatory bowel disease).

Exclusion Criteria:

  • Patients already had a stoma before the operation or in case of emergent surgery.
Contacts and Locations

Locations
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Spain
Hospital Universitario Virgen Del Rocio
Sevilla, Seville, Spain, 41013
Sponsors and Collaborators
Mª Victoria Maestre Sanchez
Hospitales Universitarios Virgen del Rocío
Investigators
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Principal Investigator: ANA Mª GARCIA CABRERA, PHD coloproctology unit
Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date  ICMJE July 1, 2014
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Rate of.complications [ Time Frame: First 30 days after surgery ]
    Surgical complications
  • Rate of mortality (assessed by Clavien-Dindo Classification) [ Time Frame: First 30 days after surgery ]
    Patient mortality within the first 30 days after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Rate of readmissions [ Time Frame: the first 30 days after surgery ]
    Number of patient hospitalization within the first 30 days after surgery
  • Reinterventions [ Time Frame: 30 days after surgery ]
    Patient new surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Educational Program for Ostomy Patients (Ostomeducat)
Official Title  ICMJE Study to Assess the Impact of an Educational Program for Ostomy Patients (Ostomeducat)
Brief Summary Stoma surgery is a relatively common treatment for patients suffering from colorectal diseases.This study aimed to investigate the impact on hospital stay and short-term overall complications prior to and following the introduction of an outpatient preoperative stoma education program.
Detailed Description 38 patients undergoing stoma surgery were analyzed, 73 prior education program and 65 following it.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Educational Problems
  • Colostomy Complications
  • Surgery
  • Colorectal Disorders
Intervention  ICMJE
  • Other: Preoperative education
    65 patients were instructed to a preoperative stoma-education program
  • Other: Postoperative education
    73 patients, receiving the same information in postoperative period.
Study Arms  ICMJE
  • Preoperative education
    Each patient had individual consultation several days before surgery with the stoma nurse specialist, following standard ostomy teaching plans
    Interventions:
    • Other: Preoperative education
    • Other: Postoperative education
  • Postoperative education
    Each patient had individual consultationseveral days before surgery with the stoma nurse specialist, following standard ostomy teaching plans
    Interventions:
    • Other: Preoperative education
    • Other: Postoperative education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2019) 		138
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2015
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients older than 18 years of age undergoing elective colorectal resections that eventually would require formation of a stoma (colorectal cancer up to 20 cm from the anal verge, colonic poliposis and inflammatory bowel disease).

Exclusion Criteria:

  • Patients already had a stoma before the operation or in case of emergent surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995719
Other Study ID Numbers  ICMJE EPOP2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Publishing
Supporting Materials: Study Protocol
Time Frame: between July 2014 and June 2015
Access Criteria:

patients older than 18 years of age undergoing elective colorectal resections that eventually would require formation of a stoma (colorectal cancer up to 20 cm from the anal verge, colonic poliposis and inflammatory bowel disease).

Patients were excluded from the study if they already had a stoma before the operation or in case of emergent surgery.
Responsible Party Mª Victoria Maestre Sanchez, Hospitales Universitarios Virgen del Rocío
Study Sponsor  ICMJE Mª Victoria Maestre Sanchez
Collaborators  ICMJE Hospitales Universitarios Virgen del Rocío
Investigators  ICMJE
Principal Investigator: ANA Mª GARCIA CABRERA, PHD coloproctology unit
PRS Account Hospitales Universitarios Virgen del Rocío
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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