Fascial ClosureNCT03111134
A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial
A study testing modified component separation technique in people with Fascial Closure, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fascial Closure
- What is being tested?
- modified component separation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 Dec 2018
- 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
- adult patients >18 years of age
- undergoing gastric cancer surgery
- undergoing abdominal surgery first time
- median upper abdominal incision applied (length of incision > 5cm)
- randomly select abdominal closure technique agreed by patients and family members
Who cannot join
- women who pregnant
- coagulation disorders
- undergoing immunological therapy
- undergoing chemothearphy within 2 weeks before the surgery
- undergoing Abdominal radiotherapy within 8 weeks before the surgery
- spirit disease patients
Show all 9Show fewer
- the expecting life span less than 48 hours
- no guarantees to follow-up for 3 years
- patients with poor compliance
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital
Xi’an, Shanxi, 710032
Xiaonan Liu, Ph.D, +86 29 84771533, liuxnxjh@163.com
About this study
At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. There are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. The key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing.
It's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. But the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia.
Read more
Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing.
In this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-CST will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.
- Conditions
- Fascial Closure
- Being tested
- modified component separation technique
- Keywords
- abdominal wound closure techniques, layered closure, component separation technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified component separation techniqueProcedure or surgery
a new abdomen closure technique based on component separation technique
| Study group | Role | What they receive |
|---|---|---|
| Routine Abdominal Closure | No intervention | Not described |
| New Abdominal Closure | Experimental | modified component separation technique is used to abdomen closing. Receives: Procedure: modified component separation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Class A healing rate of the surgical incision
Class A healing rate of the surgical incision after operation
Measured: 1 month
Secondary outcomes (9)
the incidence rate of incisional complications
the incidence rate of any incisional complications after the surgery
Measured: 1 month
the time of suture to clear
the time of suture to clear after the surgery
Measured: 1 month
hospitalization time after operation
hospitalization time after operation
Measured: 1 year
the incidence rate of unplanned second operation
the incidence rate of unplanned second operation after the surgery
Measured: 1 month
the incidence rate of unplanned readmission
the incidence rate of unplanned readmission after the surgery
Measured: 1 month
the incidence rate of acute pain
the incidence rate of acute pain after the surgery
Measured: 1 month
the mortality
the mortality after the surgery with any reason
Measured: 1 month
the incidence rate of incisional hernia
the incidence rate of incisional hernia after the surgery
Measured: 3 years
hospitalization costs
hospitalization costs for the surgery and its complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fascial ClosureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaonan Liu, Xijing Hospital of Digestive Diseases
- Investigators
- Xiaonan Liu, Ph.D, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111134
- Sponsor's protocol ID
- CST001
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Abdomen Closure Technology Based on Component Separation: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03111134
- Acronym / sponsor ID
- CST001
- Conditions
- Fascial Closure
- Keywords
- abdominal wound closure techniques, layered closure, component separation technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 12 Apr 2017 (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.
At present, open-type abdominal surgery is routine access into the abdomen. Median incision is the common choice with open-type abdominal surgery. Layered abdomen-closing is often used at the end-time of the surgery. There are some common postoperative complications, such as incision pain, surgical site infection, surgical incision dehiscence and incisional hernia. The key to reduce the incidence of postoperative complications depends on safe and reliable technology of abdomen-closing.
It's usually difficult to close the abdomen after the incisional hernia surgery, and the recurrence of incisional hernia is high. But the recurrence fell off observably when component separation technology was applied to abdomen-closing of incisional hernia.
Based on this, we hypothesis that modified-CST applied to abdomen-closing in routine abdominal surgery may improve the quality of wound-healing.
In this prospective single-blind randomized controlled trial, traditional abdomen-closing technology and modified-CST will be used to gastric cancer surgery, and the quality of wound-healing will be evaluated to confirm which kind of abdomen-closing technology better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Abdominal Closure | No intervention | – |
| New Abdominal Closure | Experimental | Procedure: modified component separation techniquemodified component separation technique is used to abdomen closing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients >18 years of age
- undergoing gastric cancer surgery
- undergoing abdominal surgery first time
- median upper abdominal incision applied (length of incision > 5cm)
- randomly select abdominal closure technique agreed by patients and family members
Key exclusion criteria (9 listed)
- women who pregnant
- coagulation disorders
- undergoing immunological therapy
- undergoing chemothearphy within 2 weeks before the surgery
- undergoing Abdominal radiotherapy within 8 weeks before the surgery
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 |
|---|---|---|
| modified component separation techniquea new abdomen closure technique based on component separation technique | Procedure or surgery | New Abdominal Closure |
Primary outcome
Class A healing rate of the surgical incision
Time frame: 1 month
Class A healing rate of the surgical incision after operation
9 secondary outcomes
the incidence rate of incisional complications
Time frame: 1 month
the time of suture to clear
Time frame: 1 month
hospitalization time after operation
Time frame: 1 year
the incidence rate of unplanned second operation
Time frame: 1 month
the incidence rate of unplanned readmission
Time frame: 1 month
the incidence rate of acute pain
Time frame: 1 month
the mortality
Time frame: 1 month
the incidence rate of incisional hernia
Time frame: 3 years
hospitalization costs
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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.
Xiaonan Liu, Ph.D study chair
Xijing 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 modified component separation technique in people with Fascial Closure, run by Xijing Hospital of Digestive Diseases 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 5 inclusion and 9 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 12 Apr 2017. 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 Xiaonan Liu, Ph.D (86-029-84771533, liuxnxjh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Class A healing rate of the surgical incision (time frame: 1 month). 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 12 Apr 2017.