Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia

Ventral Hernia Clinical Trial

Official title:

Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia... Does it Help?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05526209
• Other study ID #: Ventral Hernia
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: Mostafa H Mohamed sabry Hussien, resident
• Phone: +20 01004298223
• Email: mostafagendy95[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• any patient with Ventral Hernia admitted at Assiut University Hospital

Exclusion Criteria:

• recurrent hernia

• complicated [obstructed & strangulated]

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Recurrence
• Ventral Hernia

Intervention

Procedure:
• using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Bencini 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. — View Citation

Berrevoet F. Prevention of Incisional Hernias after Open Abdomen Treatment. Front Surg. 2018 Feb 26;5:11. doi: 10.3389/fsurg.2018.00011. eCollection 2018. Review. — View Citation

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. — View Citation

de 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. — View Citation

Heniford 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. — View Citation

Petro 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. — View Citation

Schlosser 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. — View Citation

Souza 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	longitudinal relaxing incision	the efficiency of using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia	baseline