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Use of Mosquito Net Mesh for Ventral Hernia Repair

Primary Purpose

Hernia, Ventral, Ventral Incisional Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rives technique
Drainage
Prophylactic
Sponsored by
Hospital Central "Dr. Ignacio Morones Prieto"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Ventral focused on measuring Mosquito net, Mesh, Polypropylene mesh, Prolene mesh, ventral hernia, hernia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    mosquito net mesh

    prolene mesh

    Arm Description

    The open ventral hernia repair were carried out with rives technique, followed by the placement of the mosquito net mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.

    The open ventral hernia repair were carried out with rives technique, followed by the placement of the prolene mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.

    Outcomes

    Primary Outcome Measures

    Rate of Recurrence
    Rate of Reappearance of a ventral hernia post procedure after a year.

    Secondary Outcome Measures

    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.
    Seroma
    A seroma is a collection of fluid that builds up under the surface of your skin.
    length of hospital stay
    the average number of days that patients spend in hospital.

    Full Information

    First Posted
    October 18, 2017
    Last Updated
    November 7, 2017
    Sponsor
    Hospital Central "Dr. Ignacio Morones Prieto"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03324854
    Brief Title
    Use of Mosquito Net Mesh for Ventral Hernia Repair
    Official Title
    Use of Mosquito Net Mesh in Comparison With Polypropylene Mesh for Ventral Hernia Repair.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    October 30, 2017 (Actual)
    Study Completion Date
    March 30, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Central "Dr. Ignacio Morones Prieto"

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hernia, Ventral, Ventral Incisional Hernia
    Keywords
    Mosquito net, Mesh, Polypropylene mesh, Prolene mesh, ventral hernia, hernia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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 ®) and , and 10 patients in the group of mesh of PEBD (mosquito net).
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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 participant and the outcomes assessor did not know the type of mesh.
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mosquito net mesh
    Arm Type
    Experimental
    Arm Description
    The open ventral hernia repair were carried out with rives technique, followed by the placement of the mosquito net mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.
    Arm Title
    prolene mesh
    Arm Type
    Active Comparator
    Arm Description
    The open ventral hernia repair were carried out with rives technique, followed by the placement of the prolene mesh, and left active-close drainage, 30 minutes before the incisión, prophylactic antibiotic 1gm of cefalotin was administered.
    Intervention Type
    Procedure
    Intervention Name(s)
    Rives technique
    Intervention Description
    Open ventral hernia repair followed by the placement of the mesh.
    Intervention Type
    Procedure
    Intervention Name(s)
    Drainage
    Intervention Description
    Placement of active-close drainage in surgical site.
    Intervention Type
    Drug
    Intervention Name(s)
    Prophylactic
    Other Intervention Name(s)
    Prevention
    Intervention Description
    Prophylactic antibiotic 1gm of cefalotin was administered 30 minutes before the incisión.
    Primary Outcome Measure Information:
    Title
    Rate of Recurrence
    Description
    Rate of Reappearance of a ventral hernia post procedure after a year.
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Infection
    Description
    Number of participants with open ventral hernia repair that have adverse events as infection post procedure determined by clinical, leukocytosis and positive bacterial culture.
    Time Frame
    first week, 1 month, 3 month, 6 month and One year
    Title
    Seroma
    Description
    A seroma is a collection of fluid that builds up under the surface of your skin.
    Time Frame
    first week, 1 month, 3 month, 6 month and One year
    Title
    length of hospital stay
    Description
    the average number of days that patients spend in hospital.
    Time Frame
    Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesus M Sanchez, MD
    Organizational Affiliation
    Universidad autonoma de san luis potosi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    As a preliminary study, its not finish yet.
    Citations:
    PubMed Identifier
    22864684
    Citation
    Sorensen 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.
    Results Reference
    result
    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
    Results Reference
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    PubMed Identifier
    26760085
    Citation
    Lofgren 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.
    Results Reference
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    PubMed Identifier
    21850553
    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/s13304-011-0103-6. Epub 2011 Aug 18.
    Results Reference
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    PubMed Identifier
    21713575
    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.
    Results Reference
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    Citation
    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
    Results Reference
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    PubMed Identifier
    22174320
    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. No abstract available.
    Results Reference
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    PubMed Identifier
    23340707
    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.
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    PubMed Identifier
    23485076
    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 Feb 15.
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    PubMed Identifier
    17562124
    Citation
    Sanders DL, Kingsnorth AN. Operation hernia: humanitarian hernia repairs in Ghana. Hernia. 2007 Oct;11(5):389-91. doi: 10.1007/s10029-007-0238-z. Epub 2007 Jun 12.
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    PubMed Identifier
    17595545
    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. doi: 10.1159/000104402. Epub 2007 Jun 25.
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    PubMed Identifier
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    Citation
    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 2016 Nov 23.
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    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 25.
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    Citation
    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. doi: 10.1080/10255842.2015.1016004. Epub 2015 Mar 10.
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    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 income countries. Hernia. 2017 Jun;21(3):397-405. doi: 10.1007/s10029-017-1608-9. Epub 2017 Apr 13.
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    Citation
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    Use of Mosquito Net Mesh for Ventral Hernia Repair

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