Wound InfectionACAOANCT02574364
Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures
A study testing The application of abdomen CT and traditional incision in people with Wound Infection and Complication, run by Ningbo Municipal No.4 Hospital.
Trial summary
The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception. In a randomized controlled trial of modified incision versus traditional incision. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Wound Infection, Complication, Scar
- What is being tested?
- The application of abdomen CT and traditional incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 730 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Apr 2015
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a clinical diagnosis of acute appendicitis
Who cannot join
- children under 14 are not included
About this study
The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception.
In a randomized controlled trial of modified incision versus traditional incision. Length of hospital day was the primary terminus, while operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.
Read the detailed description
Traditional open appendicectomy have many drawbacks, such as false-positive, cut infection, scar, extended cut, slower rehabilitation and return to work. In the past few years, in order to improve diagnostic accuracy, the abdomen CT is been general applied before appendicectomy, in addition to, a modified incision (MI) was designed based on it. Using a MI compare traditional incision (TI) to the patient including cut extended, operating time, cut infection, false-positive rate, rehabilitation and return to work. It seems that MI would prove superior to TI in terms of hospital day (primary terminus), with operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.
- Conditions
- Wound Infection, Complication, Scar
- Being tested
- The application of abdomen CT, traditional incision
- Keywords
- abdomen CT, open appendicectomy
- Medical subject headings
- Wound Infection, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The application of abdomen CTRadiation
A modified incision(MI)was designed based on abdomen CT.Using a MI compare traditional incision(TI) to the patient including cut extended, operating time,cut infection, false-positive rate,rehabilitation and return to work.
traditional incisionOther
McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| traditional incision | Active comparator | traditional incision : McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon. Receives: Other: traditional incision |
| modified incision | Experimental | modified incision :The application of abdomen CT before surgery provides a new approach to the incision and new perception. Receives: Radiation: The application of abdomen CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital day
Measured: 2 weeks
Secondary outcomes (3)
time to return to normal activity and work in days
Measured: up to 4 weeks
operating time in minutes
Measured: 180 Minutes
numbers of extended cut, numbers of infection,numbers of intraperitoneal abscess
Measured: 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Municipal No.4 Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, weng xinhai, Ningbo Municipal No.4 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574364
- Sponsor's protocol ID
- wxinhai
- Acronym
- ACAOA
- Status last verified
- Oct 2015
- First submitted
- 29 Sep 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures
- ClinicalTrials.gov ID
- NCT02574364
- Acronym / sponsor ID
- ACAOA / wxinhai
- Conditions
- Wound Infection, Complication, Scar
- Keywords
- abdomen CT, open appendicectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Ningbo Municipal No.4 HospitalOther government
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Oct 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.
The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception.
In a randomized controlled trial of modified incision versus traditional incision. Length of hospital day was the primary terminus, while operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.
Detailed description
Traditional open appendicectomy have many drawbacks, such as false-positive, cut infection, scar, extended cut, slower rehabilitation and return to work. In the past few years, in order to improve diagnostic accuracy, the abdomen CT is been general applied before appendicectomy, in addition to, a modified incision (MI) was designed based on it. Using a MI compare traditional incision (TI) to the patient including cut extended, operating time, cut infection, false-positive rate, rehabilitation and return to work. It seems that MI would prove superior to TI in terms of hospital day (primary terminus), with operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional incision | Active comparator | Other: traditional incisiontraditional incision : McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon. |
| modified incision | Experimental | Radiation: The application of abdomen CTmodified incision :The application of abdomen CT before surgery provides a new approach to the incision and new perception. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a clinical diagnosis of acute appendicitis
Key exclusion criteria (1 listed)
- children under 14 are not included
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 |
|---|---|---|
| The application of abdomen CTA modified incision(MI)was designed based on abdomen CT.Using a MI compare traditional incision(TI) to the patient including cut extended, operating time,cut infection, false-positive rate,rehabilitation and return to work. | Radiation | modified incision |
| traditional incisionMcBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon. | Other | traditional incision |
Primary outcome
hospital day
Time frame: 2 weeks
3 secondary outcomes
time to return to normal activity and work in days
Time frame: up to 4 weeks
operating time in minutes
Time frame: 180 Minutes
numbers of extended cut, numbers of infection,numbers of intraperitoneal abscess
Time frame: 1 weeks
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 12 Oct 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing The application of abdomen CT and traditional incision in people with Wound Infection and Complication, run by Ningbo Municipal No.4 Hospital.
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 1 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
hospital day (time frame: 2 weeks). 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 Oct 2015.