ColostomyGSICT1126NCT02053948
Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Reverse Stoma
A study testing Pursestring Wound Closure and Gunsight Skin Incision and Closure Technique in people with Colostomy, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colostomy
- What is being tested?
- Pursestring Wound Closure and Gunsight Skin Incision and Closure Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2013to 30 Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- loop colostomy
- end colostomy
Who cannot join
- other stomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Stoma Reversal Comparing Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Eliminate the Risk of Wound Infection
The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. The aim of this study is to compare the rates of superficial wound infection, healing time and patient satisfaction after pursestring closure vs "gunsight" skin incision and closure technique closure.
- Conditions
- Colostomy
- Being tested
- Pursestring Wound Closure, Gunsight Skin Incision and Closure Technique
- Keywords
- Reversal, Surgical technique, Pursestring Wound Closure, Gunsight Skin Incision and Closure Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursestring Wound ClosureProcedure or surgery
Gunsight Skin Incision and Closure TechniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pursestring Wound Closure group | Experimental | use Pursestring Wound Closure technique to close the stoma Receives: Procedure: Pursestring Wound Closure |
| Gunsight Skin Incision and Closure group | Experimental | use Gunsight Skin Incision and Closure Technique to close the stoma Receives: Procedure: Gunsight Skin Incision and Closure Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
superficial wound infection of stoma site
Measured: 1 year
Secondary outcomes (1)
Healing time after stoma reversal
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study start30 Nov 2013
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ColostomyStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Shengjing Hospital, Hebei Medical University Fourth Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University People's Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital, Jinling Hospital, China, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Hospital of China Medical University
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Jiagang Han, Professor, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053948
- Sponsor's protocol ID
- GSICT1126
- Acronym
- GSICT1126
- Status last verified
- Sep 2019
- First submitted
- 26 Nov 2013
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Camacho-Mauries D, Rodriguez-Diaz JL, Salgado-Nesme N, Gonzalez QH, Vergara-Fernandez O. Randomized clinical trial of intestinal ostomy takedown comparing pursestring wound closure vs conventional closure to eliminate the risk of wound infection. Dis Colon Rectum. 2013 Feb;56(2):205-11. doi: 10.1097/DCR.0b013e31827888f6.
PubMed 23303149Lim JT, Shedda SM, Hayes IP. "Gunsight" skin incision and closure technique for stoma reversal. Dis Colon Rectum. 2010 Nov;53(11):1569-75. doi: 10.1007/DCR.0b013e3181f0535a.
PubMed 20940608Han JG, Yao HW, Zhou JP, Zhang H, Wang GY, Shen ZL, Gong JF, Wang ZJ; Colorectal Surgery Group of Chinese Academic Society of Young Surgeons. Gunsight Procedure Versus the Purse-String Procedure for Closing Wounds After Stoma Reversal: A Multicenter Prospective Randomized Trial. Dis Colon Rectum. 2020 Oct;63(10):1411-1418. doi: 10.1097/DCR.0000000000001755.
PubMed 32969884
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. 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 "Gunsight" Skin Incision and Closure Technique to Eliminate the Risk of Wound Infection
- ClinicalTrials.gov ID
- NCT02053948
- Acronym / sponsor ID
- GSICT1126 / GSICT1126
- Conditions
- Colostomy
- Keywords
- Reversal, Surgical technique, Pursestring Wound Closure, Gunsight Skin Incision and Closure Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Shengjing Hospital, Hebei Medical University Fourth Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University People's Hospital, Peking Union Medical College Hospital, Chinese PLA General Hospital, Jinling Hospital, China, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Hospital of China Medical University
- Study start
- 30 Nov 2013
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 4 Feb 2014 (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.
The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. The aim of this study is to compare the rates of superficial wound infection, healing time and patient satisfaction after pursestring closure vs "gunsight" skin incision and closure technique closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pursestring Wound Closure group | Experimental | Procedure: Pursestring Wound Closureuse Pursestring Wound Closure technique to close the stoma |
| Gunsight Skin Incision and Closure group | Experimental | Procedure: Gunsight Skin Incision and Closure Techniqueuse Gunsight Skin Incision and Closure Technique to close the stoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- loop colostomy
- end colostomy
Key exclusion criteria (1 listed)
- other stomy
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 Closure | Procedure or surgery | Pursestring Wound Closure group |
| Gunsight Skin Incision and Closure Technique | Procedure or surgery | Gunsight Skin Incision and Closure group |
Primary outcome
superficial wound infection of stoma site
Time frame: 1 year
1 secondary outcome
Healing time after stoma reversal
Time frame: 1 year
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 10 Sep 2019.
- Background: PubMed 23303149Camacho-Mauries D, Rodriguez-Diaz JL, Salgado-Nesme N, Gonzalez QH, Vergara-Fernandez O. Randomized clinical trial of intestinal ostomy takedown comparing pursestring wound closure vs conventional closure to eliminate the risk of wound infection. Dis Colon Rectum. 2013 Feb;56(2):205-11. doi: 10.1097/DCR.0b013e31827888f6.
- Background: PubMed 20940608Lim JT, Shedda SM, Hayes IP. "Gunsight" skin incision and closure technique for stoma reversal. Dis Colon Rectum. 2010 Nov;53(11):1569-75. doi: 10.1007/DCR.0b013e3181f0535a.
- Derived from this study: PubMed 32969884Han JG, Yao HW, Zhou JP, Zhang H, Wang GY, Shen ZL, Gong JF, Wang ZJ; Colorectal Surgery Group of Chinese Academic Society of Young Surgeons. Gunsight Procedure Versus the Purse-String Procedure for Closing Wounds After Stoma Reversal: A Multicenter Prospective Randomized Trial. Dis Colon Rectum. 2020 Oct;63(10):1411-1418. doi: 10.1097/DCR.0000000000001755.
- the Technique used in this trialLink provided by the sponsor.
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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.
Jiagang Han, Professor principal investigator
Beijing Chao Yang Hospital
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 and Gunsight Skin Incision and Closure Technique in people with Colostomy, run by Beijing Chao Yang Hospital 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 1 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 10 Sep 2019. 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?
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?
superficial wound infection of stoma site (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053948, which also lists 3 linked publications.
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 Sep 2019.