Ventral HerniaNCT03255239
Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias
A study testing Ventral hernia repair in people with Ventral Hernia and Ventral Incisional Hernia, run by Hôpital Universitaire Taher Sfar at 1 site in Tunisia.
Trial summary
Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia, Ventral Incisional Hernia, Umbilical Hernia
- What is being tested?
- Ventral hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Aug 2017to 31 Dec 2019
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vebtral hernia or post incisional hernia diameter < 3 cm
- Male or female aged between 18 and 90 year-old
- Elective surgery for ventral hernia
Who cannot join
- Any contraindication to the prosthetic treatment.
- Any hernia or incisional hernia with a collar strictly greater than 3 cm.
- Previous hernia mesh repaired
- contraindication for general anaesthesia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Taher Sfar Hospital
Mahdia, 5100
CHAOUCH RD Mohamed Ali, Resident, +21626205105 ext. 5070, Docmedalichaouch@gmail.com
About this study
Official title: Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter
Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter
Read the detailed description
Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.
- Conditions
- Ventral Hernia, Ventral Incisional Hernia, Umbilical Hernia
- Being tested
- Ventral hernia repair
- Keywords
- ventral hernia, Open mesh repair, Polyester mesh, Preperitoneal, Retromuscular
- Medical subject headings
- Hernia, Ventral, Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventral hernia repairProcedure or surgery
Also called retromuscular mesh repair, preperitoneal mesh repair, suture hernia repair
Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.
| Study group | Role | What they receive |
|---|---|---|
| Preperitoneal mesh repair | Experimental | Ventral hernia repair using polyester preperitoneal mesh repair Receives: Procedure: Ventral hernia repair |
| Retromuscular mesh repair | Experimental | Ventral hernia repair using polyester retromuscular mesh repair Receives: Procedure: Ventral hernia repair |
| Suture repair | Experimental | Ventral hernia repair using suture repair Receives: Procedure: Ventral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rates
Late complications of ventral hernia repair
Measured: One year
Secondary outcomes (3)
Operating time
operating time evaluated as skin-to-skin time
Measured: 15 to 90 minutes
Early complication
Early complicaion including seroma and hematoma formation, wound infection and fistula
Measured: 30 days
Postoperative pain
Postoperative pain evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit
Measured: 6, 12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2017
- Study completion31 Dec 2019 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Taher Sfar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Ali Chaouch, Hôpital Universitaire Taher Sfar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255239
- Sponsor's protocol ID
- Abdominal wall hernia repair
- Status last verified
- Aug 2017
- First submitted
- 15 Aug 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Open Preperitoneal Mesh, Retromuscular Mesh and Suture Repair for Abdominal Wall Hernias Less Than 3 cm Diameter
- ClinicalTrials.gov ID
- NCT03255239
- Acronym / sponsor ID
- Abdominal wall hernia repair
- Conditions
- Ventral Hernia, Ventral Incisional Hernia, Umbilical Hernia
- Keywords
- ventral hernia, Open mesh repair, Polyester mesh, Preperitoneal, Retromuscular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hôpital Universitaire Taher SfarOther government
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 Aug 2017 (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.
Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter
Detailed description
Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preperitoneal mesh repair | Experimental | Procedure: Ventral hernia repairVentral hernia repair using polyester preperitoneal mesh repair |
| Retromuscular mesh repair | Experimental | Procedure: Ventral hernia repairVentral hernia repair using polyester retromuscular mesh repair |
| Suture repair | Experimental | Procedure: Ventral hernia repairVentral hernia repair using suture repair |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Vebtral hernia or post incisional hernia diameter < 3 cm
- Male or female aged between 18 and 90 year-old
- Elective surgery for ventral hernia
Key exclusion criteria (5 listed)
- Any contraindication to the prosthetic treatment.
- Any hernia or incisional hernia with a collar strictly greater than 3 cm.
- Previous hernia mesh repaired
- contraindication for general anaesthesia
- Pregnancy
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 |
|---|---|---|
| Ventral hernia repairAlso: retromuscular mesh repair, preperitoneal mesh repair, suture hernia repairHernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position. | Procedure or surgery | Preperitoneal mesh repair, Retromuscular mesh repair, Suture repair |
Primary outcome
Recurrence rates
Time frame: One year
Late complications of ventral hernia repair
3 secondary outcomes
Operating time
Time frame: 15 to 90 minutes
Early complication
Time frame: 30 days
Postoperative pain
Time frame: 6, 12 and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- 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 Ventral hernia repair in people with Ventral Hernia and Ventral Incisional Hernia, run by Hôpital Universitaire Taher Sfar at 1 site in Tunisia.
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 3 inclusion and 5 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 Aug 2017. 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 Tunisia. 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 Moez Boudokhane, MD (98461511 ext. +216, Moez-chir@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rates (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 23 Aug 2017.