Hernia, VentralE-STITCHNCT04098380
Small Versus Large Bite Closure of Emergency Midline Laparotomy
A study testing Small Bite and Larger bite in people with Hernia, Ventral, run by Mansoura University at 1 site in Egypt.
Trial summary
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Hernia, Ventral
- What is being tested?
- Small Bite and Larger bite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2019to 30 Dec 2021
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients of both sexes aging less than 70 years old
Who cannot join
- All procedures which will be performed on elective basis will be excluded
- patients who are pregnant.
- Patients on systemic steroid or chemotherapy
- patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
Sameh Emile, M.D, 01006267150, sameh200@hotmail.com
Sameh H Emile, M.D.
About this study
Official title: A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy.
A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study.
The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.
- Conditions
- Hernia, Ventral
- Being tested
- Small Bite, Larger bite
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small BiteProcedure or surgery
the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
Larger biteProcedure or surgery
the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
| Study group | Role | What they receive |
|---|---|---|
| Small bite | Active comparator | The needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm Receives: Procedure: Small Bite |
| Large bite | Active comparator | The needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm Receives: Procedure: Larger bite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of incisional hernia
Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start21 Sep 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh Emile, M.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098380
- Sponsor's protocol ID
- Mansoura104
- Acronym
- E-STITCH
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Small Versus Large Bite Closure of Emergency Midline Laparotomy
- ClinicalTrials.gov ID
- NCT04098380
- Acronym / sponsor ID
- E-STITCH / Mansoura104
- Conditions
- Hernia, Ventral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Sep 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 23 Sep 2019 (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.
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen. However, incisional hernia stands as the most common complication following this type of incision, with an incidence reaching up to 20% and even higher in the case of emergency laparotomy.
A recent randomized controlled trial compared small bite sutures and large bite closure of elective midline laparotomy and reported a significant decrease of incisional hernia rate from 18% to 5.6% in favor of small-bite technique. These promising results were subsequently confirmed in a wide-scale multicenter double-blinded randomized trial, the STITCH study.
The investigators will conduct this randomized controlled trial to compare the small tissue bite (SB) technique and the large bite (LB) technique for closure of emergency midline laparotomy. The main outcome of the study will be the incidence of incisional hernia within one year after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small bite | Active comparator | Procedure: Small BiteThe needle bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm |
| Large bite | Active comparator | Procedure: Larger biteThe needle bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of both sexes aging less than 70 years old
Key exclusion criteria (4 listed)
- All procedures which will be performed on elective basis will be excluded
- patients who are pregnant.
- Patients on systemic steroid or chemotherapy
- patients with incisional hernia or fascial defect; and/or relaparotomy within 30-days of another surgical intervention.
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 |
|---|---|---|
| Small Bitethe bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm | Procedure or surgery | Small bite |
| Larger bitethe bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm | Procedure or surgery | Large bite |
Primary outcome
Incidence of incisional hernia
Time frame: 12 months after surgery
Diagnosis of incisional hernia within 12 months after surgery by clinical examination or by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- 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.
Sameh Emile, M.D. principal investigator
Mansoura 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 Small Bite and Larger bite in people with Hernia, Ventral, run by Mansoura 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 4 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 23 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 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?
Contact Sameh Emile, M.D. (201006767150, sameh200@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of incisional hernia (time frame: 12 months after surgery). 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 23 Sep 2019.