NCT03324854

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

October 18, 2017

Last Update Submit

November 7, 2017

Conditions

Hernia, VentralVentral Incisional Hernia

Keywords

Mosquito netMeshPolypropylene meshProlene meshventral herniahernia

Outcome Measures

Primary Outcomes (1)

  • Rate of Recurrence

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

    One year

Secondary Outcomes (3)

  • Infection

    first week, 1 month, 3 month, 6 month and One year

  • Seroma

    first week, 1 month, 3 month, 6 month and One year

  • length of hospital stay

    Days

Study Arms (2)

mosquito net mesh

EXPERIMENTAL

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.

Procedure: Rives techniqueProcedure: DrainageDrug: Prophylactic

prolene mesh

ACTIVE COMPARATOR

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.

Procedure: Rives techniqueProcedure: DrainageDrug: Prophylactic

Interventions

Rives techniquePROCEDURE

Open ventral hernia repair followed by the placement of the mesh.

mosquito net meshprolene mesh
DrainagePROCEDURE

Placement of active-close drainage in surgical site.

mosquito net meshprolene mesh
ProphylacticDRUG

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

Also known as: Prevention
mosquito net meshprolene mesh

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • 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.

    PMID: 22864684RESULT

  • 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

    RESULT

  • 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.

    PMID: 26760085RESULT

  • 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.

    PMID: 21850553RESULT

  • 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.

    PMID: 21713575RESULT

  • 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

    RESULT

  • 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.

    PMID: 22174320RESULT

  • 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.

    PMID: 23340707RESULT

  • 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.

    PMID: 23485076RESULT

  • 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.

    PMID: 17562124RESULT

  • 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.

    PMID: 17595545RESULT

  • 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.

    PMID: 27878640RESULT

  • 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.

    PMID: 26730055RESULT

  • 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.

    PMID: 25756655RESULT

  • 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.

    PMID: 28409276RESULT

  • 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.

    PMID: 26146103RESULT

MeSH Terms

Conditions

Hernia, VentralHernia

Interventions

Drainage

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • Jesus M Sanchez, MD

    Universidad autonoma de san luis potosi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of general surgery, Department of surgery

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 30, 2017

Study Start

July 1, 2016

Primary Completion

October 30, 2017

Study Completion

March 30, 2018

Last Updated

November 9, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

As a preliminary study, its not finish yet.