Hernia, VentralNCT03324854
Use of Mosquito Net Mesh for Ventral Hernia Repair
A study testing Rives technique, Drainage and Prophylactic in people with Hernia, Ventral and Ventral Incisional Hernia, run by Hospital Central "Dr. Ignacio Morones Prieto".
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hernia, Ventral, Ventral Incisional Hernia
- What is being tested?
- Rives technique, Drainage and Prophylactic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Use of Mosquito Net Mesh in Comparison With Polypropylene Mesh for Ventral Hernia Repair.
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.
Read the 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.
- Conditions
- Hernia, Ventral, Ventral Incisional Hernia
- Being tested
- Rives technique, Drainage, Prophylactic
- Keywords
- Mosquito net, Mesh, Polypropylene mesh, Prolene mesh, ventral hernia, hernia
- Medical subject headings
- Hernia, Ventral, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rives techniqueProcedure or surgery
Open ventral hernia repair followed by the placement of the mesh.
DrainageProcedure or surgery
Placement of active-close drainage in surgical site.
ProphylacticDrug
Also called Prevention
Prophylactic antibiotic 1gm of cefalotin was administered 30 minutes before the incisión.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Rives technique; Procedure: Drainage; Drug: 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. Receives: Procedure: Rives technique; Procedure: Drainage; Drug: Prophylactic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recurrence
Rate of Reappearance of a ventral hernia post procedure after a year.
Measured: One year
Secondary outcomes (3)
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.
Measured: first week, 1 month, 3 month, 6 month and One year
Seroma
A seroma is a collection of fluid that builds up under the surface of your skin.
Measured: first week, 1 month, 3 month, 6 month and One year
length of hospital stay
the average number of days that patients spend in hospital.
Measured: Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Jul 2016
- Primary completion30 Oct 2017
- Study completion30 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hernia, VentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Esmer, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- Jesus M Sanchez, MD, Study director, Universidad autonoma de san luis potosi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324854
- Sponsor's protocol ID
- 1721
- Status last verified
- Nov 2017
- First submitted
- 18 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As a preliminary study, its not finish yet.
Publications
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.
PubMed 22864684Tangaokar 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
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.
PubMed 26760085Gundre 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.
PubMed 21850553Stephenson 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.
PubMed 21713575Tongaonkar 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
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.
PubMed 22174320Sanders 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.
PubMed 23340707Sanders 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.
PubMed 23485076Sanders 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.
PubMed 17562124Wilhelm 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.
PubMed 17595545Wiessner 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.
PubMed 27878640Sharma 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.
PubMed 26730055Ambroziak 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.
PubMed 25756655Patterson 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.
PubMed 28409276
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mosquito Net Mesh in Comparison With Polypropylene Mesh for Ventral Hernia Repair.
- ClinicalTrials.gov ID
- NCT03324854
- Acronym / sponsor ID
- 1721
- Conditions
- Hernia, Ventral, Ventral Incisional Hernia
- Keywords
- Mosquito net, Mesh, Polypropylene mesh, Prolene mesh, ventral hernia, hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Mar 2018 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| mosquito net mesh | Experimental | Procedure: Rives technique, Procedure: Drainage, Drug: ProphylacticThe 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. |
| prolene mesh | Active comparator | Procedure: Rives technique, Procedure: Drainage, Drug: ProphylacticThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rives techniqueOpen ventral hernia repair followed by the placement of the mesh. | Procedure or surgery | mosquito net mesh, prolene mesh |
| DrainagePlacement of active-close drainage in surgical site. | Procedure or surgery | mosquito net mesh, prolene mesh |
| ProphylacticAlso: PreventionProphylactic antibiotic 1gm of cefalotin was administered 30 minutes before the incisión. | Drug | mosquito net mesh, prolene mesh |
Primary outcome
Rate of Recurrence
Time frame: One year
Rate of Reappearance of a ventral hernia post procedure after a year.
3 secondary outcomes
Infection
Time frame: first week, 1 month, 3 month, 6 month and One year
Seroma
Time frame: first week, 1 month, 3 month, 6 month and One year
length of hospital stay
Time frame: Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Results publication: PubMed 22864684Sorensen 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 publicationTangaokar 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 publication: PubMed 26760085Lofgren 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 publication: PubMed 21850553Gundre 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 publication: PubMed 21713575Stephenson 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 publicationTongaonkar 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 publication: PubMed 22174320Stephenson 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 publication: PubMed 23340707Sanders 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 publication: PubMed 23485076Sanders 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 publication: PubMed 17562124Sanders 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 publication: PubMed 17595545Wilhelm 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 publication: PubMed 27878640Wiessner 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.
- Individual participant dataSharing planned: No. As a preliminary study, its not finish yet.
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus M Sanchez, MD study director
Universidad autonoma de san luis potosi
Questions about this trial
What is this clinical trial studying?
A study testing Rives technique, Drainage and Prophylactic in people with Hernia, Ventral and Ventral Incisional Hernia, run by Hospital Central "Dr. Ignacio Morones Prieto".
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recurrence (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324854, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.