Abdominal Wall WoundNCT06016426
Mass Closure vs Layer by Layer Closure
A study testing Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants. in people with Abdominal Wall Wound and Ventral Hernia, run by Tanta University at 1 site in Egypt.
Trial summary
to assess two different ways of closure of laparotomy in children and infants Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Abdominal Wall Wound, Ventral Hernia, Incisional Hernia
- What is being tested?
- Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2023to 30 Nov 2024
- 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 3 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all infants and children with transverse laparotomy
Who cannot join
- previous abdominal operations
- children and infants with congenital abdominal wall defects
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospitals
Tanta, Gharbia Governorate, 31111
Nagi E eldessouki, professor, +20 201003546853, "nagi2709Staff" <neldesoky@med.tanta.edu.eg>
Suzan E Gado, professor
About this study
Official title: Mass Closure vs Layer by Layer Closure of the Transverse Abdominal Laparotomy Incisions in Infants and Children: a Randomized Clinical Trial
to assess two different ways of closure of laparotomy in children and infants
Read the detailed description
Introduction:
The technique of abdominal wall closure in infants subjected to abdominal transverse laparotomy incision may have an impact not only on the development of a future incisional hernia but also on the function of the anterior abdominal wall muscles.
There are two ways to close this laparotomy incision. These ways are either closure in mass or layer by layer closure. Neither of them is superior to the other.
The main issue that minds the pediatric surgeons is a safe and successful repair of the abdominal wall incision and the avoidance of the development of incisional hernia.
The aim of this work is to randomly compare the two different techniques of the closure of transverse laparotomy incision.
Patients and methods:
- Study design: The study was performed during the period from January 2020 to October 2024. It is a randomized control trial.
Inclusion criteria were infants younger than 3 years. We excluded infants with history of prematurity, previous abdominal operations and infants with congenital abdominal wall defects.
An informed consent was obtained from the parents or the care giver of every participant.
Randomization was obtained using closed envelop method. Patients were categorized into two groups A and B. Group A included patients that their exploratory wound was closed with mass closure method using Vicryl® 2/0 round needle. Group B included patients that their exploratory wound was closed layer by layer using the same suture material.
In both groups the ratio of the suture length to the wound was 3 to 1. - The measured variables: The variables that were addressed were
- the mean operative time in minutes,
- the incidence of wound dehiscence,
- the occurrence of wound infection,
- The development of an incisional hernia
- Long term assessment of both abdominal wall structure and dynamics of abdominal muscles at the site of incision.
- Follow up protocol:
All patients were scheduled on a follow up regimen. They were examined weekly for one month post-operative. Then monthly for one year. The anterior abdominal wall of these patients was examined by ultrasound at the 6th and 12th moth postoperatively. This helped assessment of the dynamics and structure of the muscles at the site of the incision.
- Statistical analysis: Statistical analysis was conducted using SPSS ™ statistical package ver. 21 (IBM SPSS, NY, USA). Numerical data were compared using an independent sample t-test, whereas categorical data were compared using the chi-square test. Statistical significance was set at p <0.05.
- Conditions
- Abdominal Wall Wound, Ventral Hernia, Incisional Hernia
- Being tested
- Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.
- Keywords
- transverse laparotomy, incisional hernia, mass closure, layer by layer closure
- Medical subject headings
- Hernia, Ventral, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.Other
the transverse laparotomy incision in infants and children will be either closed as single layer included the peritoneum, posterior rectus sheath and anterior rectus sheath wit muscle sparing, or the laparotomy will be closed in layer by layer in which the peritoneum and posterior rectus sheath are closed as a layer and the anterior rectus sheath is closed as a seprate layer.
| Study group | Role | What they receive |
|---|---|---|
| mass closure | Active comparator | infants and children whose transverse laparotomy incisions will be closed in mass closure. Receives: Other: Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants. |
| layer by layer closure | Active comparator | infants and children whose transverse laparotomy incisions will be closed layer by layer. Receives: Other: Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound failure with the development of incisional hernia later in either group
the occurrence or development of the incisional hernia is the primary outcome. the incidence of the development of this hernia will be recorded in each group. this will help choose the more appropriate method of transverse laparotomy closure in infants and children
Measured: one year
Secondary outcomes (1)
surgical site infections
the number of patients who will develop a surgical site infections in each group, the mean duration of hospital stay if this happened. the number of patients who will later develop an incisional hernia
Measured: two weeks up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start30 Sep 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall WoundStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gharieb Mohammad Khirallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016426
- Sponsor's protocol ID
- 36264PR286/8/23
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Closure vs Layer by Layer Closure of the Transverse Abdominal Laparotomy Incisions in Infants and Children: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06016426
- Acronym / sponsor ID
- 36264PR286/8/23
- Conditions
- Abdominal Wall Wound, Ventral Hernia, Incisional Hernia
- Keywords
- transverse laparotomy, incisional hernia, mass closure, layer by layer closure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 29 Aug 2023 (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.
to assess two different ways of closure of laparotomy in children and infants
Detailed description
Introduction:
The technique of abdominal wall closure in infants subjected to abdominal transverse laparotomy incision may have an impact not only on the development of a future incisional hernia but also on the function of the anterior abdominal wall muscles.
There are two ways to close this laparotomy incision. These ways are either closure in mass or layer by layer closure. Neither of them is superior to the other.
The main issue that minds the pediatric surgeons is a safe and successful repair of the abdominal wall incision and the avoidance of the development of incisional hernia.
The aim of this work is to randomly compare the two different techniques of the closure of transverse laparotomy incision.
Patients and methods:
- Study design: The study was performed during the period from January 2020 to October 2024. It is a randomized control trial.
Inclusion criteria were infants younger than 3 years. We excluded infants with history of prematurity, previous abdominal operations and infants with congenital abdominal wall defects.
An informed consent was obtained from the parents or the care giver of every participant.
Randomization was obtained using closed envelop method. Patients were categorized into two groups A and B. Group A included patients that their exploratory wound was closed with mass closure method using Vicryl® 2/0 round needle. Group B included patients that their exploratory wound was closed layer by layer using the same suture material.
In both groups the ratio of the suture length to the wound was 3 to 1. - The measured variables: The variables that were addressed were
- the mean operative time in minutes,
- the incidence of wound dehiscence,
- the occurrence of wound infection,
- The development of an incisional hernia
- Long term assessment of both abdominal wall structure and dynamics of abdominal muscles at the site of incision.
- Follow up protocol:
All patients were scheduled on a follow up regimen. They were examined weekly for one month post-operative. Then monthly for one year. The anterior abdominal wall of these patients was examined by ultrasound at the 6th and 12th moth postoperatively. This helped assessment of the dynamics and structure of the muscles at the site of the incision.
- Statistical analysis: Statistical analysis was conducted using SPSS ™ statistical package ver. 21 (IBM SPSS, NY, USA). Numerical data were compared using an independent sample t-test, whereas categorical data were compared using the chi-square test. Statistical significance was set at p <0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mass closure | Active comparator | Other: Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.infants and children whose transverse laparotomy incisions will be closed in mass closure. |
| layer by layer closure | Active comparator | Other: Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.infants and children whose transverse laparotomy incisions will be closed layer by layer. |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all infants and children with transverse laparotomy
Key exclusion criteria (2 listed)
- previous abdominal operations
- children and infants with congenital abdominal wall defects
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 |
|---|---|---|
| Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.the transverse laparotomy incision in infants and children will be either closed as single layer included the peritoneum, posterior rectus sheath and anterior rectus sheath wit muscle sparing, or the laparotomy will be closed in layer by layer in which the peritoneum and posterior rectus sheath are closed as a layer and the anterior rectus sheath is closed as a seprate layer. | Other | layer by layer closure, mass closure |
Primary outcome
wound failure with the development of incisional hernia later in either group
Time frame: one year
the occurrence or development of the incisional hernia is the primary outcome. the incidence of the development of this hernia will be recorded in each group. this will help choose the more appropriate method of transverse laparotomy closure in infants and children
1 secondary outcome
surgical site infections
Time frame: two weeks up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants. in people with Abdominal Wall Wound and Ventral Hernia, run by Tanta 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 1 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound failure with the development of incisional hernia later in either group (time frame: one 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 29 Aug 2023.