Abdominal Wall DefectNCT05278117
A Prospective Multicentre Study Evaluating the Outcomes of the Abdominal Wall Dehiscence Repair Using Posterior Component Separation With Transversus Abdominis Muscle Release Reinforced by a Retro-muscular Mesh - Filling a Step
A study testing outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh in people with Abdominal Wall Defect, run by Zagazig University at 1 site in Egypt.
Trial summary
Purpose: This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Defect
- What is being tested?
- outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2014to 1 Feb 2022
- 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
- BA Grade IA according to Björck's initial classification following midline laparotomy from various departments,
- ≥ 18 years
- both sex
- emergency or elective surgery
Who cannot join
- BA grade 1B,2,3, and 4 according to Björck's initial classification,
- < 18 years,
- primary laparotomy performed through a non-midline incision, open abdomen,
- if another laparotomy had been performed between the surgery for BA and the end of the follow-up period,
- concomitant intra-abdominal surgery, abdominal complications during BA surgery,
- adherent bowel to the defect edge that cannot be separated,
Show all 14Show fewer
- patients lost during follow up,
- presence of intra-abdominal contamination that cannot be controlled radiologically,
- history of previous BA repair,
- stoma exteriorized from the midline primary wound,
- temporarily wound closure techniques,
- prior abdominal surgeries other than operation resulted in BA,
- prior abdominal wall hernia repair with or without mesh,
- history of collagen diseases
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.
Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.
Read the detailed description
This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.
Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.
- Conditions
- Abdominal Wall Defect
- Being tested
- outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh
- Keywords
- Abdomen burst, Incisional hernia, mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay meshProcedure or surgery
outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh
| Study group | Role | What they receive |
|---|---|---|
| complete burst abdomen repair | Experimental | complete burst abdomen repair Receives: Procedure: outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent burst abdomen
incidence of recurrent burst abdomen by %
Measured: 3.5 years
incisional hernia
incidence of incisional hernia measured by clinical examination and computerized tomography by %
Measured: 3.5 years
Secondary outcomes (1)
incidence of surgical site infection
by %
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Jun 2014
- Primary completion1 Apr 2018
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall DefectStudies of the same condition, open and under way.
- More trials run by Zagazig 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer Alsaied Alnaimy, Zagazig University
- Investigators
- Alnaimy alnaimy, Phd, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278117
- Sponsor's protocol ID
- burst abdomen
- Status last verified
- Sep 2022
- First submitted
- 3 Mar 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habeeb TAAM, Hussain A, Shelat V, Chiaretti M, Bueno-Lledo J, Garcia Fadrique A, Kalmoush AE, Elnemr M, Safwat K, Raafat A, Wasefy T, Heggy IA, Osman G, Abdelhady WA, Mawla WA, Fiad AA, Elaidy MM, Amr W, Abdelhamid MI, Abdou AM, Ibrahim AIA, Baghdadi MA. A prospective multicentre study evaluating the outcomes of the abdominal wall dehiscence repair using posterior component separation with transversus abdominis muscle release reinforced by a retro-muscular mesh: filling a step. World J Emerg Surg. 2023 Mar 3;18(1):15. doi: 10.1186/s13017-023-00485-9.
PubMed 36869364
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Study Evaluating the Outcomes of the Abdominal Wall Dehiscence Repair Using Posterior Component Separation With Transversus Abdominis Muscle Release Reinforced by a Retro-muscular Mesh - Filling a Step
- ClinicalTrials.gov ID
- NCT05278117
- Acronym / sponsor ID
- burst abdomen
- Conditions
- Abdominal Wall Defect
- Keywords
- Abdomen burst, Incisional hernia, mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 14 Mar 2022 (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.
Purpose: This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.
Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.
Detailed description
This study determined the incidence of burst abdomen recurrent (BAR), incisional hernia(IH), and surgical site occurrence (SSO) following burst abdomen surgical treatment after abdominal midline incisions using a posterior component separation(CS) technique with transversus abdominis muscle release (TAR) reinforced by retro-muscular mesh technique.
Methods: Between June 2014 and April 2018, 202 patients with grade IA BA (Björck's first classification) were treated in a prospective multiple-center cohort study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| complete burst abdomen repair | Experimental | Procedure: outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay meshcomplete burst abdomen repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BA Grade IA according to Björck's initial classification following midline laparotomy from various departments,
- ≥ 18 years
- both sex
- emergency or elective surgery
Key exclusion criteria (14 listed)
- BA grade 1B,2,3, and 4 according to Björck's initial classification,
- < 18 years,
- primary laparotomy performed through a non-midline incision, open abdomen,
- if another laparotomy had been performed between the surgery for BA and the end of the follow-up period,
- concomitant intra-abdominal surgery, abdominal complications during BA 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 |
|---|---|---|
| outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay meshoutcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh | Procedure or surgery | complete burst abdomen repair |
Primary outcome
recurrent burst abdomen
Time frame: 3.5 years
incidence of recurrent burst abdomen by %
incisional hernia
Time frame: 3.5 years
incidence of incisional hernia measured by clinical examination and computerized tomography by %
1 secondary outcome
incidence of surgical site infection
Time frame: 30 days
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 7 Sep 2022.
- Derived from this study: PubMed 36869364Habeeb TAAM, Hussain A, Shelat V, Chiaretti M, Bueno-Lledo J, Garcia Fadrique A, Kalmoush AE, Elnemr M, Safwat K, Raafat A, Wasefy T, Heggy IA, Osman G, Abdelhady WA, Mawla WA, Fiad AA, Elaidy MM, Amr W, Abdelhamid MI, Abdou AM, Ibrahim AIA, Baghdadi MA. A prospective multicentre study evaluating the outcomes of the abdominal wall dehiscence repair using posterior component separation with transversus abdominis muscle release reinforced by a retro-muscular mesh: filling a step. World J Emerg Surg. 2023 Mar 3;18(1):15. doi: 10.1186/s13017-023-00485-9.
- Individual participant dataSharing planned: No
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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.
Alnaimy alnaimy, Phd principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outcomes of complete burst abdomen repair using posterior component separation technique with transversus abdominis muscle release reinforced by sublay mesh in people with Abdominal Wall Defect, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 14 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 7 Sep 2022. 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 Egypt. 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?
recurrent burst abdomen (time frame: 3.5 years). The study lists 2 primary outcomes in all. 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 NCT05278117, which also lists 1 linked publication.
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 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.