Colorectal CancerNCT04375930
Peristomal Skin Complications and Quality of Life
A study testing STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION in people with Colorectal Cancer and Quality of Life, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study is a single blind semi-experimental study. Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Quality of Life, Stoma Ileostomy
- What is being tested?
- STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergoing colorectal surgery,
- permanent or temporary ileostomy or colostomy
- end or loop ileostomy or colostomy
Who cannot join
- individuals who have previously had stoma surgery,
- having two or more stoma,
- individuals with crohn's disease
- individuals who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Standard-Based Care on Peristomal Skin Complications and Quality of Life in Ostomy Creation Patients With Colorectal Cancer
This study is a single blind semi-experimental study.
Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.
H1: Standard stoma care which is established evidence-based guides and complication algorithm, reduces peristomal skin complications in patients with colorectal cancer and an ostomy.
H2: Standard stoma care which is established evidence-based guides and complication algorithm, increases the quality of life in patients with colorectal cancer and an ostomy.
Read the detailed description
In order to ensure blindness in the study design, patients were not informed about which group they belonged to.
Patient with ostomy in the study group were trained in accordance with the Standard Stoma Care.
Patient with ostomy in the control group only skill and discharge training has been provided in accordance with the hospital procedure.
All patients were followed up at 2, 6, and 12 weeks. Peristomal complications were evaluated by the researcher with the Peristomal Skin Tool at the 2nd, 6th and 12th weeks. The patients were asked to fill the Stoma Quality of Life Scale in the 2nd, 6th and 12th weeks.
- Being tested
- STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION, Control
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATIONOther
STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION: It is consist of skills, discharge, compilation and algorithm education.
ControlOther
It consists of only skills and discharge education
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The patient will be trained with STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION. The patient will be follow up at 2nd, 6th and 12th weeks. Receives: Other: STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION |
| control | Active comparator | The patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Peristomal skin complication change
It has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.
Measured: 0, 2nd, 6th and 12th weeks
means of quality of life change
It has been assessed with stoma Quality of Life Scale. The Scale range: 0-100. Higher scores for each item indicate that the quality of life increased.
Measured: 2nd, 6th and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start18 Jan 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This two-group, single-blind, quasi-experimental study enrolled 68 patients with ostomy recruited to a university affiliated hospital.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cahide AYİK, Dokuz Eylul University
- Investigators
- Cahide Ayik, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375930
- Sponsor's protocol ID
- 3491-GOA
- Status last verified
- Jun 2022
- First submitted
- 27 Jan 2020
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Standard-Based Care on Peristomal Skin Complications and Quality of Life in Ostomy Creation Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04375930
- Acronym / sponsor ID
- 3491-GOA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single blind semi-experimental study.
Aim: To investigate the effect of standardized care on peristomal skin complications and quality of life in colorectal cancer patients undergoing ostomy surgery.
H1: Standard stoma care which is established evidence-based guides and complication algorithm, reduces peristomal skin complications in patients with colorectal cancer and an ostomy.
H2: Standard stoma care which is established evidence-based guides and complication algorithm, increases the quality of life in patients with colorectal cancer and an ostomy.
Detailed description
In order to ensure blindness in the study design, patients were not informed about which group they belonged to.
Patient with ostomy in the study group were trained in accordance with the Standard Stoma Care.
Patient with ostomy in the control group only skill and discharge training has been provided in accordance with the hospital procedure.
All patients were followed up at 2, 6, and 12 weeks. Peristomal complications were evaluated by the researcher with the Peristomal Skin Tool at the 2nd, 6th and 12th weeks. The patients were asked to fill the Stoma Quality of Life Scale in the 2nd, 6th and 12th weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This two-group, single-blind, quasi-experimental study enrolled 68 patients with ostomy recruited to a university affiliated hospital.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATIONThe patient will be trained with STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION. The patient will be follow up at 2nd, 6th and 12th weeks. |
| control | Active comparator | Other: ControlThe patient will be trained only skills and discharge education. The patient will be follow up at 2nd, 6th and 12th weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing colorectal surgery,
- permanent or temporary ileostomy or colostomy
- end or loop ileostomy or colostomy
Key exclusion criteria (4 listed)
- individuals who have previously had stoma surgery,
- having two or more stoma,
- individuals with crohn's disease
- individuals who do not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATIONSTANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION: It is consist of skills, discharge, compilation and algorithm education. | Other | Experimental |
| ControlIt consists of only skills and discharge education | Other | control |
Primary outcome
Rate of Peristomal skin complication change
Time frame: 0, 2nd, 6th and 12th weeks
It has been assessed with Ostomy Skin Tool. The total score can be the lowest 0 and the highest 15.
means of quality of life change
Time frame: 2nd, 6th and 12th weeks
It has been assessed with stoma Quality of Life Scale. The Scale range: 0-100. Higher scores for each item indicate that the quality of life increased.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cahide Ayik principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION in people with Colorectal Cancer and Quality of Life, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Peristomal skin complication change (time frame: 0, 2nd, 6th and 12th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.