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
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
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
NCT ID
NCT03324854
First Posted
October 18, 2017
Last Updated
November 7, 2017
Sponsor
Hospital Central "Dr. Ignacio Morones Prieto"
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
result
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
result
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
result
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
result
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
result
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
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
27878640
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.
Results Reference
result
PubMed Identifier
26730055
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.
Results Reference
result
PubMed Identifier
25756655
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.
Results Reference
result
PubMed Identifier
28409276
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.
Results Reference
result
PubMed Identifier
26146103
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. No abstract available.
Results Reference
result
Learn more about this trial
Use of Mosquito Net Mesh for Ventral Hernia Repair
We'll reach out to this number within 24 hrs