NCT03995719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

April 30, 2019

Last Update Submit

June 20, 2019

Conditions

Educational ProblemsColostomy ComplicationsSurgeryColorectal Disorders

Keywords

colostomyeducation

Outcome Measures

Primary Outcomes (2)

  • Rate of.complications

    Surgical complications

    First 30 days after surgery

  • Rate of mortality (assessed by Clavien-Dindo Classification)

    Patient mortality within the first 30 days after surgery

    First 30 days after surgery

Secondary Outcomes (2)

  • Rate of readmissions

    the first 30 days after surgery

  • Reinterventions

    30 days after surgery

Study Arms (2)

Preoperative education

OTHER

Each patient had individual consultation several days before surgery with the stoma nurse specialist, following standard ostomy teaching plans

Other: Preoperative educationOther: Postoperative education

Postoperative education

OTHER

Each patient had individual consultationseveral days before surgery with the stoma nurse specialist, following standard ostomy teaching plans

Other: Preoperative educationOther: Postoperative education

Interventions

Preoperative educationOTHER

65 patients were instructed to a preoperative stoma-education program

Postoperative educationPreoperative education
Postoperative educationOTHER

73 patients, receiving the same information in postoperative period.

Postoperative educationPreoperative education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen Del Rocio

Seville, Seville, 41013, Spain

Location

Related Publications (1)

  • Garcia-Cabrera AM, de la Portilla de Juan F, Navarro-Morales L, Ribera Garcia S, Duran Ventura MDC, Fernandez Luque I, Padillo-Ruiz FJ. Influence of Preoperative Educational Intervention for Patients Undergoing Fecal Ostomy Surgery: A Comparison Cohort Study. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):484-488. doi: 10.1097/WON.0000000000001020.

    PMID: 37966076DERIVED

Study Officials

  • ANA Mª GARCIA CABRERA, PHD

    coloproctology unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

April 30, 2019

First Posted

June 24, 2019

Study Start

July 1, 2014

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

June 24, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Publishing

Shared Documents
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.

Locations

ES(1)