Use of Mosquito Net Mesh for Ventral Hernia Repair

Hernia, Ventral Clinical Trial

Official title:

Use of Mosquito Net Mesh in Comparison With Polypropylene Mesh for Ventral Hernia Repair.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03324854
• Other study ID #: 1721
• Status: Active, not recruiting
• Phase: N/A
• First received: October 18, 2017
• Last updated: November 7, 2017
• Start date: July 1, 2016
• Est. completion date: March 30, 2018

Study information

• Verified date: November 2017
• Source: Hospital Central "Dr. Ignacio Morones Prieto"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It´s a pilot study, randomized, realized in the Central Hospital "Dr. Ignacio Morones Prieto", SLP, Mexico.

Hypothesis:

The polyethylene mesh is secure in open ventral repair.

Description:

It´s a pilot study, randomized, realized in the Central Hospital "Dr. Ignacio Morones Prieto", SLP, Mexico.

The simple size for pilot study was been calculated in 20 patients, according with Browne for not knowing the variability of the treatment. 10 patients in the group of Polypropylene mesh (Prolene ®), braided monofilament thread, macropore, weight of 108.1 g/m2, fibres diameter of 0.53 mm, tensile force of 156.6 N/cm, with a pore of 1.6 mm2, in different size of 15 x 15 cm, 20 x 20 cm and 30 x 30 cm, and 10 patients in the group of mesh of PEBD (mosquito net), braided monofilament thread, macropore, ,weight of 53.7 g/m2, fibers diameter of 0.48 mm, tensile force of 42.7 N/cm and pore of 1.8 mm2, in different size 15 x 15 cm, 20 x 20 cm and 30x 30 cm donated by Dr. Ravindranath R. Tongaonkar. The sterilization were done in ethylene oxide.

The randomisation for allocation the type of mesh for each patient was realized with numbers generated by computer with the program R version 3.0.2 with the simple function.

The statistical analysis was carried out by the programs: JMP 8 (SAS Institute Inc., Cary, NC, USA) and R 2.15.1 23.

The ventral hernia repair were carried out with standardized technique, placed the mesh int the preperitoneal or retromuscular space fixing with 2-0 poplypropylene suture and le fe active-close drainage, 30 minutes before the incision, prophylactic antibiotic 1gm of cefalotin was administered, in both groups, the patient was discharge at the first postoperatory day with drainage and retired at the first review at 1 week and recited at one, three, six and twelve months for reviewer.

The descriptive analysis of categorical variables was expressed with frequencies and percentages; the numerical ones with normal distribution in averages and standard deviation, the variables with distribution not normal with medians and status (maximum and minimal values). The values of p<0.05 were considered to be significant.

This study was evaluated and accepted by the Committee of Investigation and the Committee of Ethics, with number of record 42-17.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 30, 2018
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All the patients with primary or incisional elective ventral hernia repair with mesh were included, with ASA I,II and III between 18 and 75 years, of any sex, and that they accepted to take part in the protocol and signed the informed assent.

Exclusion Criteria:

• We excluded patients with incarcerated, strangulated hernia, signs of intestinal obstruction, consumption of anticoagulants, IMC >35, parastomal hernias, hernia repair with intestinal reconnections at the same procedure or presented infection in abdominal wall.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Incisional Hernia

Intervention

Procedure:
• Rives technique
Open ventral hernia repair followed by the placement of the mesh.
• Drainage
Placement of active-close drainage in surgical site.

Drug:
• Prophylactic
Prophylactic antibiotic 1gm of cefalotin was administered 30 minutes before the incisión.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central "Dr. Ignacio Morones Prieto"

References & Publications (16)

Ambroziak A, Szepietowska K, Lubowiecka I. Mechanical properties of mosquito nets in the context of hernia repair. Comput Methods Biomech Biomed Engin. 2016 Feb;19(3):286-296. Epub 2015 Mar 10. — View Citation

Gundre NP, Iyer SP, Subramaniyan P. Prospective randomized controlled study using polyethylene mesh for inguinal hernia meshplasty as a safe and cost-effective alternative to polypropylene mesh. Updates Surg. 2012 Mar;64(1):37-42. doi: 10.1007/s13304-011- — View Citation

Koziel S, Mitura K, Papaj P, Lorenc Z. Tension-Free Mosquito Net Mesh Inguinal Hernioplasty - an Alternative Exclusively for the Third World? Pol Przegl Chir. 2015 Feb;87(2):102-7. doi: 10.1515/pjs-2015-0027. — View Citation

Löfgren J, Nordin P, Ibingira C, Matovu A, Galiwango E, Wladis A. A Randomized Trial of Low-Cost Mesh in Groin Hernia Repair. N Engl J Med. 2016 Jan 14;374(2):146-53. doi: 10.1056/NEJMoa1505126. — View Citation

Patterson T, Currie P, Patterson S, Patterson P, Meek C, McMaster R. A systematic review and meta-analysis of the post-operative adverse effects associated with mosquito net mesh in comparison to commercial hernia mesh for inguinal hernia repair in low in — View Citation

Sanders DL, Kingsnorth AN, Moate R, Steer JA. An in vitro study assessing the infection risk of low-cost polyethylene mosquito net compared with commercial hernia prosthetics. J Surg Res. 2013 Aug;183(2):e31-7. doi: 10.1016/j.jss.2013.01.047. Epub 2013 Fe — View Citation

Sanders DL, Kingsnorth AN, Stephenson BM. Mosquito net mesh for abdominal wall hernioplasty: a comparison of material characteristics with commercial prosthetics. World J Surg. 2013 Apr;37(4):737-45. doi: 10.1007/s00268-012-1900-x. — View Citation

Sanders DL, Kingsnorth AN. Operation hernia: humanitarian hernia repairs in Ghana. Hernia. 2007 Oct;11(5):389-91. Epub 2007 Jun 12. — View Citation

Sharma M, Sharma DB, Chandrakar SK, Sharma D. Histopathological Comparison of Mosquito Net with Polypropylene Mesh for Hernia Repair: An Experimental Study in Rats. Indian J Surg. 2015 Dec;77(Suppl 2):511-4. doi: 10.1007/s12262-013-0904-6. Epub 2013 Apr 2 — View Citation

Sørensen CG, Rosenberg J. The use of sterilized mosquito nets for hernioplasty: a systematic review. Hernia. 2012 Dec;16(6):621-5. doi: 10.1007/s10029-012-0973-7. Epub 2012 Aug 3. Review. — View Citation

Stephenson BM, Kingsnorth AN. Inguinal hernioplasty using mosquito net mesh in low income countries: an alternative and cost effective prosthesis. BMJ. 2011 Dec 15;343:d7448. doi: 10.1136/bmj.d7448. — View Citation

Stephenson BM, Kingsnorth AN. Safety and sterilization of mosquito net mesh for humanitarian inguinal hernioplasty. World J Surg. 2011 Sep;35(9):1957-60. doi: 10.1007/s00268-011-1176-6. — View Citation

Tangaokar RR, Sanders DL, Kingsnorth AN (2013) Ten-Year Personal Experience of Using Low Density Polyethylene (LDPE) Mesh for Inguinal Hernia Repair. Trop Med Surg 1: 136. doi:10.4172/2329-9088.1000136

Tongaonkar RR, Reddy BV, Mehta VK et al (2003) Preliminary multicentric trial of cheap indigenous mosquito-net cloth for tension free hernia repair. Indian J Surg 65:89-95

Wiessner R, Kleber T, Ekwelle N, Ludwig K, Richter DU. In-vitro examination of the biocompatibility of fibroblast cell lines on alloplastic meshes and sterilized polyester mosquito mesh. Hernia. 2017 Jun;21(3):407-416. doi: 10.1007/s10029-016-1550-2. Epub — View Citation

Wilhelm TJ, Freudenberg S, Jonas E, Grobholz R, Post S, Kyamanywa P. Sterilized mosquito net versus commercial mesh for hernia repair. an experimental study in goats in Mbarara/Uganda. Eur Surg Res. 2007;39(5):312-7. Epub 2007 Jun 25. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Recurrence	Rate of Reappearance of a ventral hernia post procedure after a year.	One year
Secondary	Infection	Number of participants with open ventral hernia repair that have adverse events as infection post procedure determined by clinical, leukocytosis and positive bacterial culture.	first week, 1 month, 3 month, 6 month and One year
Secondary	Seroma	A seroma is a collection of fluid that builds up under the surface of your skin.	first week, 1 month, 3 month, 6 month and One year
Secondary	length of hospital stay	the average number of days that patients spend in hospital.	Days