Colorectal CancerPURSENCT02564224
Study Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients
A study testing Pursestring Wound Closure, Conventional Wound Closure and prolene in people with Colorectal Cancer and Stoma Closure Technic, run by Zhejiang University at 1 site in China.
Trial summary
Temporary stomas has been performed to reduce complications after colorectal cancer surgery, especially in high-risk anastomosis. Different closure technics showed different outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Stoma Closure Technic
- What is being tested?
- Pursestring Wound Closure, Conventional Wound Closure and prolene
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving temporary ostomy because of colorectal cancer at least 3 months ago;
- Age of≥18 and ≤80
Who cannot join
- Not willing or incapable to comply with all study visits and assessments
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310999
About this study
Official title: Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs Conventional Closure to Eliminate the VSS Score of the Scar for Colorectal Cancer Patients
Temporary stomas has been performed to reduce complications after colorectal cancer surgery, especially in high-risk anastomosis. Different closure technics showed different outcome. The aim of this study is to compare the scar length , surgical site infection and pain score of purse-string wound closure vs conventional closure.
- Conditions
- Colorectal Cancer, Stoma Closure Technic
- Being tested
- Pursestring Wound Closure, Conventional Wound Closure, prolene
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursestring Wound ClosureProcedure or surgery
Procedure: Pursestring Wound Closure
Conventional Wound ClosureProcedure or surgery
Procedure: Conventional Wound Closure
proleneDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ke-Feng, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564224
- Sponsor's protocol ID
- CRCCZ-S01
- Acronym
- PURSE
- Status last verified
- Jun 2018
- First submitted
- 29 Sep 2015
- Last updated
- 6 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs Conventional Closure to Eliminate the VSS Score of the Scar for Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT02564224
- Acronym / sponsor ID
- PURSE / CRCCZ-S01
- Conditions
- Colorectal Cancer, Stoma Closure Technic
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- First posted
- 30 Sep 2015 (estimated)
- 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.
Temporary stomas has been performed to reduce complications after colorectal cancer surgery, especially in high-risk anastomosis. Different closure technics showed different outcome. The aim of this study is to compare the scar length , surgical site infection and pain score of purse-string wound closure vs conventional closure.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving temporary ostomy because of colorectal cancer at least 3 months ago;
- Age of≥18 and ≤80
Key exclusion criteria (2 listed)
- Not willing or incapable to comply with all study visits and assessments
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications
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 |
|---|---|---|
| Pursestring Wound ClosureProcedure: Pursestring Wound Closure | Procedure or surgery | – |
| Conventional Wound ClosureProcedure: Conventional Wound Closure | Procedure or surgery | – |
| prolene | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursestring Wound Closure, Conventional Wound Closure and prolene in people with Colorectal Cancer and Stoma Closure Technic, run by Zhejiang 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 2 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 6 Jun 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 6 Jun 2018.