Ventral HerniaNCT05526209
Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia
An observational study of Ventral Hernia, run by Assiut University.
Trial summary
The aim of the study is showing the efficiency of using Longitudinal relaxing incision as a Technique for recurrence prevention in Ventral Hernia Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to May 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cases with Ventral Hernia admitted at Assiut University Hospital at the period of the study
Who may be able to join
- any patient with Ventral Hernia admitted at Assiut University Hospital
Who cannot join
- recurrent hernia
- complicated [obstructed \& strangulated]
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia... Does it Help?
The aim of the study is showing the efficiency of using Longitudinal relaxing incision as a Technique for recurrence prevention in Ventral Hernia
Read the detailed description
Ventral hernias of the abdomen are defined as a non-inguinal, nonhiatal defect in the fascia of the abdominal wall. Annually, there are about 350,000 ventral hernia operations. The repair of these abdominal wall defects is a common surgery performed by general surgeons. Surgery is typically recommended for individuals with acceptable operative risk, symptomatic hernias, or those at elevated risk of developing complications from a hernia. They can affect an individual's quality of life and can lead to hospitalizations and even death in some cases Etiologies of a ventral hernia can be broken down into 2 main categories; acquired or congenital. The vast majority of hernias that general surgeons see and treat are acquired; however, some individuals live with their ventral hernias from birth for prolonged periods of time before having them surgically repaired. Common causes of acquired ventral hernias include previous surgery causing an incisional hernia, trauma, and repetitive stress on naturally weak points of the abdominal wall. These naturally occurring weak points in the abdominal wall include the umbilicus, semilunar line, ostomy sites, bilateral inguinal regions, and esophageal hiatus. Obesity is a large component of hernias as well because it stretches the fascia of the abdomen causing it to weaken. Specifically, the action of repetitive weight gain and loss leads to weakening The most common treatment of ventral hernias includes surgery. Asymptomatic hernias are repaired on an elective basis, but those presenting with strangulation require immediate surgery. Incarceration without strangulation is not a surgical emergency; however, the risks and benefits of surgery should be discussed with the patient, and a patient with reasonable operative risk should have their hernia repaired within a sensible time frame. Non-surgical management of abdominal wall hernias with the use of binders, trusses, or corsets is not considered to be effective. However, this may be the only option in a patient who is not a reasonable candidate for surgery Over the years, many types of surgical techniques have been developed to repair hernias. There are many tenants of hernia repair. The most important being a tension-free closure, but others include the use of a mesh with 3 to 5 cm of overlap, meticulous handling of the mesh, preventing surgical site infections, and using a sublay technique with the closure of the fascia if possible. The most basic approach is a primary open repair without mesh, which should typically be reserved for defects in the fascia of less than 2 cm. An open repair with mesh has several options including what type of mesh and where to place the mesh.
Hernia recurrence is an extremely important postoperative outcome and assesses surgical efficacy. The ability to predict recurrence accurately would have considerable clinical utility, allowing surgeons to make better-informed decisions with their patients as to when and when not, to operate.
Multiple associated conditions, such as obesity, smoking, and others, have been reported in various studies to contribute to higher recurrence rates.
- Conditions
- Ventral Hernia
- Being tested
- using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using longitudinal relaxing incision as a technique for recurrence prevention in ventral herniaProcedure or surgery
using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
| Study group | Role | What they receive |
|---|---|---|
| 1 with using longitudinal relaxing incision | using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia Receives: Procedure: using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia | |
| 2 without using longitudinal relaxing incision | without using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
longitudinal relaxing incision
the efficiency of using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Hussien Mohamed sabry Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526209
- Sponsor's protocol ID
- Ventral Hernia
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho JE, Helm MC, Helm JH, Mier N, Kastenmeier AS, Gould JC, Goldblatt MI. Retro-rectus placement of bio-absorbable mesh improves patient outcomes. Surg Endosc. 2019 Aug;33(8):2629-2634. doi: 10.1007/s00464-018-6560-y. Epub 2018 Oct 25.
PubMed 30361969Petro CC, Haskins IN, Perez AJ, Tastaldi L, Strong AT, Ilie RN, Tu C, Krpata DM, Prabhu AS, Eghtesad B, Rosen MJ. Hernia repair in patients with chronic liver disease - A 15-year single-center experience. Am J Surg. 2019 Jan;217(1):59-65. doi: 10.1016/j.amjsurg.2018.10.020. Epub 2018 Oct 16.
PubMed 30343877Schlosser KA, Arnold MR, Otero J, Prasad T, Lincourt A, Colavita PD, Kercher KW, Heniford BT, Augenstein VA. Deciding on Optimal Approach for Ventral Hernia Repair: Laparoscopic or Open. J Am Coll Surg. 2019 Jan;228(1):54-65. doi: 10.1016/j.jamcollsurg.2018.09.004. Epub 2018 Oct 22.
PubMed 30359827Berrevoet F. Prevention of Incisional Hernias after Open Abdomen Treatment. Front Surg. 2018 Feb 26;5:11. doi: 10.3389/fsurg.2018.00011. eCollection 2018.
PubMed 29536013Heniford BT. SAGES guidelines for laparoscopic ventral hernia repair. Surg Endosc. 2016 Aug;30(8):3161-2. doi: 10.1007/s00464-016-5073-9. Epub 2016 Jul 15. No abstract available.
PubMed 27422242Souza JM, Dumanian GA. Routine use of bioprosthetic mesh is not necessary: a retrospective review of 100 consecutive cases of intra-abdominal midweight polypropylene mesh for ventral hernia repair. Surgery. 2013 Mar;153(3):393-9. doi: 10.1016/j.surg.2012.08.003. Epub 2012 Oct 13.
PubMed 23068089de Vries HS, Smeeing D, Lourens H, Kruyt PM, Mollen RMHG. Long-term clinical experience with laparoscopic ventral hernia repair using a ParietexTM composite mesh in severely obese and non-severe obese patients: a single center cohort study. Minim Invasive Ther Allied Technol. 2019 Oct;28(5):304-308. doi: 10.1080/13645706.2018.1521431. Epub 2018 Oct 11.
PubMed 30307356Bencini L, Sanchez LJ, Bernini M, Miranda E, Farsi M, Boffi B, Moretti R. Predictors of recurrence after laparoscopic ventral hernia repair. Surg Laparosc Endosc Percutan Tech. 2009 Apr;19(2):128-32. doi: 10.1097/SLE.0b013e31819cb04b.
PubMed 19390279
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia... Does it Help?
- ClinicalTrials.gov ID
- NCT05526209
- Acronym / sponsor ID
- Ventral Hernia
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 2 Sep 2022 (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.
The aim of the study is showing the efficiency of using Longitudinal relaxing incision as a Technique for recurrence prevention in Ventral Hernia
Detailed description
Ventral hernias of the abdomen are defined as a non-inguinal, nonhiatal defect in the fascia of the abdominal wall. Annually, there are about 350,000 ventral hernia operations. The repair of these abdominal wall defects is a common surgery performed by general surgeons. Surgery is typically recommended for individuals with acceptable operative risk, symptomatic hernias, or those at elevated risk of developing complications from a hernia. They can affect an individual's quality of life and can lead to hospitalizations and even death in some cases Etiologies of a ventral hernia can be broken down into 2 main categories; acquired or congenital. The vast majority of hernias that general surgeons see and treat are acquired; however, some individuals live with their ventral hernias from birth for prolonged periods of time before having them surgically repaired. Common causes of acquired ventral hernias include previous surgery causing an incisional hernia, trauma, and repetitive stress on naturally weak points of the abdominal wall. These naturally occurring weak points in the abdominal wall include the umbilicus, semilunar line, ostomy sites, bilateral inguinal regions, and esophageal hiatus. Obesity is a large component of hernias as well because it stretches the fascia of the abdomen causing it to weaken. Specifically, the action of repetitive weight gain and loss leads to weakening The most common treatment of ventral hernias includes surgery. Asymptomatic hernias are repaired on an elective basis, but those presenting with strangulation require immediate surgery. Incarceration without strangulation is not a surgical emergency; however, the risks and benefits of surgery should be discussed with the patient, and a patient with reasonable operative risk should have their hernia repaired within a sensible time frame. Non-surgical management of abdominal wall hernias with the use of binders, trusses, or corsets is not considered to be effective. However, this may be the only option in a patient who is not a reasonable candidate for surgery Over the years, many types of surgical techniques have been developed to repair hernias. There are many tenants of hernia repair. The most important being a tension-free closure, but others include the use of a mesh with 3 to 5 cm of overlap, meticulous handling of the mesh, preventing surgical site infections, and using a sublay technique with the closure of the fascia if possible. The most basic approach is a primary open repair without mesh, which should typically be reserved for defects in the fascia of less than 2 cm. An open repair with mesh has several options including what type of mesh and where to place the mesh.
Hernia recurrence is an extremely important postoperative outcome and assesses surgical efficacy. The ability to predict recurrence accurately would have considerable clinical utility, allowing surgeons to make better-informed decisions with their patients as to when and when not, to operate.
Multiple associated conditions, such as obesity, smoking, and others, have been reported in various studies to contribute to higher recurrence rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 with using longitudinal relaxing incision | – | Procedure: using longitudinal relaxing incision as a technique for recurrence prevention in ventral herniausing longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia |
| 2 without using longitudinal relaxing incision | – | –without using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cases with Ventral Hernia admitted at Assiut University Hospital at the period of the study
Key inclusion criteria (1 listed)
- any patient with Ventral Hernia admitted at Assiut University Hospital
Key exclusion criteria (2 listed)
- recurrent hernia
- complicated [obstructed \& strangulated]
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 |
|---|---|---|
| using longitudinal relaxing incision as a technique for recurrence prevention in ventral herniausing longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia | Procedure or surgery | 1 with using longitudinal relaxing incision |
Primary outcome
longitudinal relaxing incision
Time frame: baseline
the efficiency of using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 30361969Cho JE, Helm MC, Helm JH, Mier N, Kastenmeier AS, Gould JC, Goldblatt MI. Retro-rectus placement of bio-absorbable mesh improves patient outcomes. Surg Endosc. 2019 Aug;33(8):2629-2634. doi: 10.1007/s00464-018-6560-y. Epub 2018 Oct 25.
- Background: PubMed 30343877Petro CC, Haskins IN, Perez AJ, Tastaldi L, Strong AT, Ilie RN, Tu C, Krpata DM, Prabhu AS, Eghtesad B, Rosen MJ. Hernia repair in patients with chronic liver disease - A 15-year single-center experience. Am J Surg. 2019 Jan;217(1):59-65. doi: 10.1016/j.amjsurg.2018.10.020. Epub 2018 Oct 16.
- Background: PubMed 30359827Schlosser KA, Arnold MR, Otero J, Prasad T, Lincourt A, Colavita PD, Kercher KW, Heniford BT, Augenstein VA. Deciding on Optimal Approach for Ventral Hernia Repair: Laparoscopic or Open. J Am Coll Surg. 2019 Jan;228(1):54-65. doi: 10.1016/j.jamcollsurg.2018.09.004. Epub 2018 Oct 22.
- Background: PubMed 29536013Berrevoet F. Prevention of Incisional Hernias after Open Abdomen Treatment. Front Surg. 2018 Feb 26;5:11. doi: 10.3389/fsurg.2018.00011. eCollection 2018.
- Background: PubMed 27422242Heniford BT. SAGES guidelines for laparoscopic ventral hernia repair. Surg Endosc. 2016 Aug;30(8):3161-2. doi: 10.1007/s00464-016-5073-9. Epub 2016 Jul 15. No abstract available.
- Background: PubMed 23068089Souza JM, Dumanian GA. Routine use of bioprosthetic mesh is not necessary: a retrospective review of 100 consecutive cases of intra-abdominal midweight polypropylene mesh for ventral hernia repair. Surgery. 2013 Mar;153(3):393-9. doi: 10.1016/j.surg.2012.08.003. Epub 2012 Oct 13.
- Background: PubMed 30307356de Vries HS, Smeeing D, Lourens H, Kruyt PM, Mollen RMHG. Long-term clinical experience with laparoscopic ventral hernia repair using a ParietexTM composite mesh in severely obese and non-severe obese patients: a single center cohort study. Minim Invasive Ther Allied Technol. 2019 Oct;28(5):304-308. doi: 10.1080/13645706.2018.1521431. Epub 2018 Oct 11.
- Background: PubMed 19390279Bencini L, Sanchez LJ, Bernini M, Miranda E, Farsi M, Boffi B, Moretti R. Predictors of recurrence after laparoscopic ventral hernia repair. Surg Laparosc Endosc Percutan Tech. 2009 Apr;19(2):128-32. doi: 10.1097/SLE.0b013e31819cb04b.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by Assiut 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 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 2 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa H Mohamed sabry Hussien, resident (+20 01004298223, mostafagendy95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
longitudinal relaxing incision (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05526209, which also lists 8 linked publications.
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 2 Sep 2022.