Ventral HerniaNCT03994588
Intraperitoneal Polypropylene Light Weight Wide Pore Soft Mesh Repair for Complex Ventral Hernia.
A study testing Intraperitoneal Mesh hernia repair in people with Ventral Hernia, run by Cairo University at 1 site in Egypt.
Trial summary
Complex ventral hernia is a challenging problem well known to be associated with occurrence of serious complications. The major problems encountered in such cases Include: loss of domain with subsequent increase of intra-abdominal pressure after repair, the huge musculo-fascial defect and skin scarring with possible… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Intraperitoneal Mesh hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2019to 31 Jul 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients between 18 and 65 years of age, ASA physical status I - III with complex ventral hernia (defect width above 10 cm, loss of domain above 20 %, recurrent hernia and/or associated with fistula or abdominal wall sinuses).
Who cannot join
- Age below 18 and above 65 years. The maximum age limit would be 65 years because in our previous studies morbidity was higher in older age group (36, 37).
- Body mass index greater than 45 kg/m2 or weight above 100 kg.
- Pregnancy.
- Associated non treated abdominal malignancy.
- Unstable coronary artery disease, congestive heart failure.
- Significant renal or hepatic impairment;
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- Severe bronchopulmonary disease, including chronic obstructive pulmonary disease and obstructive sleep apnea.
- Diabetics with Hb A1c above 7.5.
- Subjects with loss of domain above 20 % who didn't respond to pre-operative progressive pneumoperitoneum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal Polypropylene Light Weight Wide Pore Soft Mesh Versus A. Double Mesh Intraperitoneal Repair for Complex Ventral Hernia: A Prospective Randomized Cohort Study.
Complex ventral hernia is a challenging problem well known to be associated with occurrence of serious complications. The major problems encountered in such cases Include: loss of domain with subsequent increase of intra-abdominal pressure after repair, the huge musculo-fascial defect and skin scarring with possible skin viability problem resulting from the dissection of skin flaps. There is no unified accepted evidence-based approach for its repair and is attended with a high recurrence rate that may reach up to 67%. In a previous study using the ADMIR technique of intraperitoneal repair and after a long-term follow-up the investigator was able to reduce the recurrence rate to 4% after an average follow up period of 142 months. In the current study the investigator will use the same technique of intraperitoneal mesh repair comparing the polypropylene light weight, wide pore, soft mesh with a double mesh using the same polypropylene mesh and a vicryl mesh as a protective layer against the bowel. If it is proven as effective as the mesh with protective layer and with no increased risk of morbidity, this will result in marked reduction of the cost of treatment by nearly 90 % and will abolish the waiting list of patients as the polypropylene mesh is readily available.
Read the detailed description
According to randomization policy, patients' will be allocated to two groups each one will include 30 subjects: Group I (the study group) in which the investigator will use a polypropylene wide pore soft mesh (Bard, USA). Group II (the control group) in which the investigator will use the same polypropylene mesh in association with Vicryl mesh (Polyglactin 910, VM95, Ethicon, Belgium). The mesh will be prepared by suturing the Vicryl and polypropylene mesh together after folding the edges (2 cm each) and its fixation with four full thickness corners Vicryl 2/0 stay sutures. Another four sutures anchoring the overlapped edges together will be applied at the center of each edge, after that, the mesh will be inserted intraperitoneally in an oblong fashion in defects above the point midway between the umbilicus and symphysis pubis and in horizontal fashion in defects in the hypogastric region with the Vicryl part facing the bowel. U sutures using polypropylene 0 will be applied through the whole thickness of the anterior abdominal wall in order to anchor the four angles of the mesh. Then, the turned over edges of the mesh will be fixed to the inner aspect of the abdominal wall using interrupted full thickness U sutures or mesh stapler (fascia stapler, Medtronic (covidien), USA) according to availability. The same technique will be used in the study group excluding the vicryl mesh. Following mesh fixation, a tailored viable part of the sac will be closed over the mesh to separate it from the subcutaneous tissue in order to minimize seroma formation. Follow-up data will be recorded in a proforma for each patient, noting intraoperative and postoperative complications and postoperative hospital-stay. Each patient will be examined by the surgical team in the Outpatient Clinic at postoperative days 7, 15, and 30 to assess early complications, and at 3 months for one year and every 6 months for 2 years, to assess late complications when necessary after making the scheduled telephone communication.
- Conditions
- Ventral Hernia
- Being tested
- Intraperitoneal Mesh hernia repair
- Keywords
- Complex ventral hernia, Polypropylene soft mesh, Intraperitoneal repair, Recurrence, Loss of Domain
- Medical subject headings
- Hernia, Ventral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal Mesh hernia repairProcedure or surgery
The mesh will be inserted intraperitoneally for complex ventral hernia repair and fixed according the previously described ADMIR technique.
| Study group | Role | What they receive |
|---|---|---|
| study arm | Active comparator | In this arm a light weight, wide pore, soft polypropylene mesh will be used for intraperitoneal hernia repair Receives: Procedure: Intraperitoneal Mesh hernia repair |
| control | Active comparator | in this arm a double mesh (vicryl + polypropylene mesh) will be used for intraperitoneal hernia repair. Receives: Procedure: Intraperitoneal Mesh hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
The development of persistent abdominal pain (VAS), intestinal obstruction or abdominal wall sinus or fistula formation.
Manifestations of intestinal obstruction in the form of abdominal pain (VAS), abdominal distention, vomiting and absolute constipation
Measured: one year
Secondary outcomes (1)
Hernia recurrence.
the development of clinically manifest or radiologically detected recurrence.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start12 Jul 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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 Cairo 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raafat Yahia Afifi, Cairo University
- Investigators
- Raafat Y Afifi, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994588
- Sponsor's protocol ID
- N-43-2019
- Status last verified
- Feb 2024
- First submitted
- 20 Jun 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Polypropylene Light Weight Wide Pore Soft Mesh Versus A. Double Mesh Intraperitoneal Repair for Complex Ventral Hernia: A Prospective Randomized Cohort Study.
- ClinicalTrials.gov ID
- NCT03994588
- Acronym / sponsor ID
- N-43-2019
- Conditions
- Ventral Hernia
- Keywords
- Complex ventral hernia, Polypropylene soft mesh, Intraperitoneal repair, Recurrence, Loss of Domain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 21 Jun 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.
Complex ventral hernia is a challenging problem well known to be associated with occurrence of serious complications. The major problems encountered in such cases Include: loss of domain with subsequent increase of intra-abdominal pressure after repair, the huge musculo-fascial defect and skin scarring with possible skin viability problem resulting from the dissection of skin flaps. There is no unified accepted evidence-based approach for its repair and is attended with a high recurrence rate that may reach up to 67%. In a previous study using the ADMIR technique of intraperitoneal repair and after a long-term follow-up the investigator was able to reduce the recurrence rate to 4% after an average follow up period of 142 months. In the current study the investigator will use the same technique of intraperitoneal mesh repair comparing the polypropylene light weight, wide pore, soft mesh with a double mesh using the same polypropylene mesh and a vicryl mesh as a protective layer against the bowel. If it is proven as effective as the mesh with protective layer and with no increased risk of morbidity, this will result in marked reduction of the cost of treatment by nearly 90 % and will abolish the waiting list of patients as the polypropylene mesh is readily available.
Detailed description
According to randomization policy, patients' will be allocated to two groups each one will include 30 subjects: Group I (the study group) in which the investigator will use a polypropylene wide pore soft mesh (Bard, USA). Group II (the control group) in which the investigator will use the same polypropylene mesh in association with Vicryl mesh (Polyglactin 910, VM95, Ethicon, Belgium). The mesh will be prepared by suturing the Vicryl and polypropylene mesh together after folding the edges (2 cm each) and its fixation with four full thickness corners Vicryl 2/0 stay sutures. Another four sutures anchoring the overlapped edges together will be applied at the center of each edge, after that, the mesh will be inserted intraperitoneally in an oblong fashion in defects above the point midway between the umbilicus and symphysis pubis and in horizontal fashion in defects in the hypogastric region with the Vicryl part facing the bowel. U sutures using polypropylene 0 will be applied through the whole thickness of the anterior abdominal wall in order to anchor the four angles of the mesh. Then, the turned over edges of the mesh will be fixed to the inner aspect of the abdominal wall using interrupted full thickness U sutures or mesh stapler (fascia stapler, Medtronic (covidien), USA) according to availability. The same technique will be used in the study group excluding the vicryl mesh. Following mesh fixation, a tailored viable part of the sac will be closed over the mesh to separate it from the subcutaneous tissue in order to minimize seroma formation. Follow-up data will be recorded in a proforma for each patient, noting intraoperative and postoperative complications and postoperative hospital-stay. Each patient will be examined by the surgical team in the Outpatient Clinic at postoperative days 7, 15, and 30 to assess early complications, and at 3 months for one year and every 6 months for 2 years, to assess late complications when necessary after making the scheduled telephone communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Active comparator | Procedure: Intraperitoneal Mesh hernia repairIn this arm a light weight, wide pore, soft polypropylene mesh will be used for intraperitoneal hernia repair |
| control | Active comparator | Procedure: Intraperitoneal Mesh hernia repairin this arm a double mesh (vicryl + polypropylene mesh) will be used for intraperitoneal hernia repair. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients between 18 and 65 years of age, ASA physical status I - III with complex ventral hernia (defect width above 10 cm, loss of domain above 20 %, recurrent hernia and/or associated with fistula or abdominal wall sinuses).
Key exclusion criteria (9 listed)
- Age below 18 and above 65 years. The maximum age limit would be 65 years because in our previous studies morbidity was higher in older age group (36, 37).
- Body mass index greater than 45 kg/m2 or weight above 100 kg.
- Pregnancy.
- Associated non treated abdominal malignancy.
- Unstable coronary artery disease, congestive heart failure.
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 |
|---|---|---|
| Intraperitoneal Mesh hernia repairThe mesh will be inserted intraperitoneally for complex ventral hernia repair and fixed according the previously described ADMIR technique. | Procedure or surgery | control, study arm |
Primary outcome
The development of persistent abdominal pain (VAS), intestinal obstruction or abdominal wall sinus or fistula formation.
Time frame: one year
Manifestations of intestinal obstruction in the form of abdominal pain (VAS), abdominal distention, vomiting and absolute constipation
1 secondary outcome
Hernia recurrence.
Time frame: three years
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 15 Feb 2024.
- Individual participant dataSharing planned: Yes. Data can be shared at the end of the study.
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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.
Raafat Y Afifi, MD principal investigator
Cairo 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 Intraperitoneal Mesh hernia repair in people with Ventral Hernia, run by Cairo 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 9 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 15 Feb 2024. 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?
The development of persistent abdominal pain (VAS), intestinal obstruction or abdominal wall sinus or fistula formation. (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 15 Feb 2024.