Colorectal CarcinomaPhase 2STAPLERNCT02652702
Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients
A Phase 2 study testing circular stapler-assisted colostomy and conventional hand-stitching colostomy in people with Colorectal Carcinoma, run by Zhejiang University at 1 site in China.
Trial summary
Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- circular stapler-assisted colostomy and conventional hand-stitching colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Jan 2020
- Phase
- Phase 2
- 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 permanent colostomy because of colorectal cancer
- 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 Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients
Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.But all those reports are single center retrospective cohort study，no randomized controlled trials have been carried out so far.The aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.
Read the detailed description
It has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.Thus, various postoperative colostomy complications are inevitable after surgery. Surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications.
So we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.
- Conditions
- Colorectal Carcinoma
- Being tested
- circular stapler-assisted colostomy, conventional hand-stitching colostomy
- Keywords
- circular stapler-assisted colostomy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circular stapler-assisted colostomyProcedure or surgery
procedure:circular stapler-assisted colostomy device:circular stapler
conventional hand-stitching colostomyProcedure or surgery
procedure:hand-stitching colostomy
| Study group | Role | What they receive |
|---|---|---|
| Circular Stapler-assisted Colostomy | Experimental | Using Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma. Receives: Procedure: circular stapler-assisted colostomy |
| Hand-stitching Colostomy | Experimental | Using Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma. Receives: Procedure: conventional hand-stitching colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
colostomy associated complications
measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018
- Study completionJan 2020
Why it stopped: Not enough patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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
- NCT02652702
- Sponsor's protocol ID
- CRCCZ-D01
- Acronym
- STAPLER
- Status last verified
- Jul 2020
- First submitted
- 29 Dec 2015
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT02652702
- Acronym / sponsor ID
- STAPLER / CRCCZ-D01
- Conditions
- Colorectal Carcinoma
- Keywords
- circular stapler-assisted colostomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients recruited
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 12 Jan 2016 (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.
Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.But all those reports are single center retrospective cohort study，no randomized controlled trials have been carried out so far.The aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.
Detailed description
It has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.Thus, various postoperative colostomy complications are inevitable after surgery. Surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications.
So we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circular Stapler-assisted Colostomy | Experimental | Procedure: circular stapler-assisted colostomyUsing Circular Stapler-assisted Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma. |
| Hand-stitching Colostomy | Experimental | Procedure: conventional hand-stitching colostomyUsing Conventional Hand-stitching Technique to Finish Colostomy after colorectal carcinoma surgery when patient need permanent sigmoid stoma. |
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 permanent colostomy because of colorectal cancer
- 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 |
|---|---|---|
| circular stapler-assisted colostomyprocedure:circular stapler-assisted colostomy device:circular stapler | Procedure or surgery | Circular Stapler-assisted Colostomy |
| conventional hand-stitching colostomyprocedure:hand-stitching colostomy | Procedure or surgery | Hand-stitching Colostomy |
Primary outcome
colostomy associated complications
Time frame: 2 year
measure the colostomy associated complications,such like hemorrhage,necrosis, stenosis, prolapse, and para-stomal hernia.
Results and safety
The study was stopped early (reason given: Not enough patients recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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 Phase 2 study testing circular stapler-assisted colostomy and conventional hand-stitching colostomy in people with Colorectal Carcinoma, 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: stopped early, as of the sponsor's last update on 7 Jul 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough patients recruited). 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.
What does the primary outcome measure?
colostomy associated complications (time frame: 2 year). 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 7 Jul 2020; AzTrials last refreshed its copy on 5 Nov 2026.