Surgical StomasNCT04682028
Construction and Evaluation of a Stoma Patient Continuous Care Network
A study testing professional care and coventional care in people with Surgical Stomas, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Construct a professional network platformof continuous care for patients with enterostomy and evaluate its availability， Eventually, patients with enterostomy will have access to care outside the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Stomas
- What is being tested?
- professional care and coventional care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged≥18 years old;
- patients undergoing enterostomy;
- patients possess a smart phone and know how to use it;
- patients volunteer to participate in the survey.
Who cannot join
- patients have a history of mental disorders;
- cancer has metastasized to other organs, or there are other serious physical diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
first Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Xiulin Wen, 0086-13991893501, wenxiulin1981@qq.com
About this study
Official title: Construction and Evaluation a Network Platform of Continuous Care for Ostomy Patients
Construct a professional network platformof continuous care for patients with enterostomy and evaluate its availability， Eventually, patients with enterostomy will have access to care outside the hospital.
Read the detailed description
The project to establish a professional care network for stomas patient will be conducted at first Affiliated Hospital Xi'an Jiaotong University.This network platform that patients can enjoy to make an appointment, video interrogation, the inspection booking, self management, health education, and other health and extension services;nursing staff can undertake colostomy online learning and assessment of the relevant knowledge and skills;professional colostomy care is published to provide remote guidance.the efficacy of the network was evaluated by investigating complications rate,and their self-care ability,quality of life, and medical expenses,and patients'satisfaction.
- Conditions
- Surgical Stomas
- Being tested
- professional care, coventional care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
professional careOther
The trained nurses provide professional care for the patients.
coventional careOther
nurses provide coventional care for the patients.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | Other | Nurses provide web-based continuous care to patients. Receives: Other: professional care |
| contral group | Other | Nurses provide the routine care to patients. Receives: Other: coventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
stomy Quality of Life,Stoma-QOL
The scale includes 20 items with a score ranging from 20 to 80points.The higher the score,the better the quality of life.
Measured: up to 9 months
Secondary outcomes (2)
Enterostomy Patients Self-management Questionnaire
The scale includes 5 dimensions,30items;The higher the score,the better the Self-management.
Measured: up to 9 months
Stoma and surrounding complications
Stoma complications include infection around the stoma,skin and mocous membrane separation, hemorrhage etal.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Dec 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical StomasStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiulin Wen, Study chair, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682028
- Sponsor's protocol ID
- XJTU1AF2020LSK-228
- Status last verified
- Aug 2021
- First submitted
- 20 Dec 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation a Network Platform of Continuous Care for Ostomy Patients
- ClinicalTrials.gov ID
- NCT04682028
- Acronym / sponsor ID
- XJTU1AF2020LSK-228
- Conditions
- Surgical Stomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Dec 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.
Construct a professional network platformof continuous care for patients with enterostomy and evaluate its availability， Eventually, patients with enterostomy will have access to care outside the hospital.
Detailed description
The project to establish a professional care network for stomas patient will be conducted at first Affiliated Hospital Xi'an Jiaotong University.This network platform that patients can enjoy to make an appointment, video interrogation, the inspection booking, self management, health education, and other health and extension services;nursing staff can undertake colostomy online learning and assessment of the relevant knowledge and skills;professional colostomy care is published to provide remote guidance.the efficacy of the network was evaluated by investigating complications rate,and their self-care ability,quality of life, and medical expenses,and patients'satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | Other | Other: professional careNurses provide web-based continuous care to patients. |
| contral group | Other | Other: coventional careNurses provide the routine care to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients aged≥18 years old;
- patients undergoing enterostomy;
- patients possess a smart phone and know how to use it;
- patients volunteer to participate in the survey.
Key exclusion criteria (2 listed)
- patients have a history of mental disorders;
- cancer has metastasized to other organs, or there are other serious physical diseases.
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 |
|---|---|---|
| professional careThe trained nurses provide professional care for the patients. | Other | experiment group |
| coventional carenurses provide coventional care for the patients. | Other | contral group |
Primary outcome
stomy Quality of Life,Stoma-QOL
Time frame: up to 9 months
The scale includes 20 items with a score ranging from 20 to 80points.The higher the score,the better the quality of life.
2 secondary outcomes
Enterostomy Patients Self-management Questionnaire
Time frame: up to 9 months
Stoma and surrounding complications
Time frame: up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
Related trials for Surgical Stomas
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Active, not recruiting
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Rectal Cancer Surgery
Not yet recruiting
Comparison of the Effectiveness of ERAS Protocol (Enhanced Recovery After Surgery) Versus Traditional Care in Pediatric Ileostomy Reversal Surgery
Ileostomy - Stoma
Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Colorectal Surgery, Colorectal Cancer
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.
Xiulin Wen study chair
First Affiliated Hospital of Xian Jiaotong 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 professional care and coventional care in people with Surgical Stomas, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 May 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingrong Wang (0086-17629259023, 350672758@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stomy Quality of Life,Stoma-QOL (time frame: up to 9 months). 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 10 May 2022.