Ventral HerniaNCT03721575
Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty
A study testing Scarpa's preserving hernio-abdominoplasty and Classical hernio-abdominoplasty in people with Ventral Hernia, run by Mansoura University.
Trial summary
This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Scarpa's preserving hernio-abdominoplasty and Classical hernio-abdominoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Oct 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with complex ventral hernia that are fit for surgery (ASA class I and II) (Saklad, 1941).
- Patients with class III, IV according to Pitanguy's classification of abdominal deformities (Pitanguy, 1995).
Who cannot join
- Patient with ASA class III, IV, and V.
- Morbid obesity (BMI > 40).
- Recurrent incisional hernias after mesh hernioplasty.
- Strangulated hernias.
- Isolated small paraumbilical hernias.
- Patients with abdominal organomegaly and/or ascites.
- Patients with coagulopathy,
- Patients who are heavy smokers, patients with pulmonary problems, and patients with uncontrolled diabetes.
About this study
Official title: Scarpa Fascia Preservation Versus Removal During Hernio-abdominoplasty: a Randomized Controlled Trial
This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate.
- Conditions
- Ventral Hernia
- Being tested
- Scarpa's preserving hernio-abdominoplasty, Classical hernio-abdominoplasty
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scarpa's preserving hernio-abdominoplastyProcedure or surgery
Scarpa's fascia is preserved during hernio-abdominoplasty
Classical hernio-abdominoplastyProcedure or surgery
Scarpa's fascia is removed during hernio-abdominoplasty
| Study group | Role | What they receive |
|---|---|---|
| Scarpa's preserving hernio-abdominoplasty | Active comparator | Hernio-abdominoplasty is performed with preservation of Scarpa's fascia. Receives: Procedure: Scarpa's preserving hernio-abdominoplasty |
| Classical hernio-abdominoplasty | Active comparator | Hernio-abdominoplasty is performed with removalof Scarpa's fascia. Receives: Procedure: Classical hernio-abdominoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of postoperative drainage
The volume of fluid drained through suction drains per 24 hours
Measured: Two weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Jan 2016
- Primary completion1 Jan 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721575
- Sponsor's protocol ID
- mansoura61
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 26 Oct 2018
- 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 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scarpa Fascia Preservation Versus Removal During Hernio-abdominoplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03721575
- Acronym / sponsor ID
- mansoura61
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 26 Oct 2018 (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.
This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scarpa's preserving hernio-abdominoplasty | Active comparator | Procedure: Scarpa's preserving hernio-abdominoplastyHernio-abdominoplasty is performed with preservation of Scarpa's fascia. |
| Classical hernio-abdominoplasty | Active comparator | Procedure: Classical hernio-abdominoplastyHernio-abdominoplasty is performed with removalof Scarpa's fascia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with complex ventral hernia that are fit for surgery (ASA class I and II) (Saklad, 1941).
- Patients with class III, IV according to Pitanguy's classification of abdominal deformities (Pitanguy, 1995).
Key exclusion criteria (8 listed)
- Patient with ASA class III, IV, and V.
- Morbid obesity (BMI > 40).
- Recurrent incisional hernias after mesh hernioplasty.
- Strangulated hernias.
- Isolated small paraumbilical hernias.
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 |
|---|---|---|
| Scarpa's preserving hernio-abdominoplastyScarpa's fascia is preserved during hernio-abdominoplasty | Procedure or surgery | Scarpa's preserving hernio-abdominoplasty |
| Classical hernio-abdominoplastyScarpa's fascia is removed during hernio-abdominoplasty | Procedure or surgery | Classical hernio-abdominoplasty |
Primary outcome
Volume of postoperative drainage
Time frame: Two weeks after surgery
The volume of fluid drained through suction drains per 24 hours
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 26 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Ventral Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
Hernia, Ventral, Hernia Incisional
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
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 H Emile principal investigator
Mansoura University
Questions about this trial
What is this clinical trial studying?
A study testing Scarpa's preserving hernio-abdominoplasty and Classical hernio-abdominoplasty in people with Ventral Hernia, run by Mansoura University.
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 2 inclusion and 8 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 26 Oct 2018. 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?
Volume of postoperative drainage (time frame: Two weeks 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 26 Oct 2018.