Effectiveness of a Lightweight Mesh in the Laparoscopic Prevention of Parastomal Hernia
Study of the Effectiveness of a Lightweight Mesh (Polypropylene and Poliglecaprone 25 and Oxidized Cellulose) in the Prevention of Parastomal Hernia in Patients Requiring a Permanent Ostomy. Laparoscopic Approach
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Parastomal hernia (PH) is a very common complication after abdominal surgery that requires a permanent ostomy. This type of surgery is usually associated with processes that fall within the scope of Coloproctology.PH is difficult to deal with high rates of recurrence after surgical repair.This type of hernia remains a problem of first order, generating a significant consumption of health and economic resources and determining an impaired quality of life of these patients.Laparoscopic surgery is increasingly used in colorectal surgery.
Also with this type of approach is present the problem of prevention of PH. The use of a mesh in the repair of hernias is not discussed since the placement of a prosthesis significantly reduces the recurrence rate. There are now many types of prosthetic meshes available. A low weight mesh composed of large pores (about 5mm) with a high proportion of absorbable material and a layer of oxidized regenerated cellulose which is placed in the vicinity of the bowel is available on the market (PROCEED ®, Ethicon). The introduction of this low-weight mesh provides a good opportunity to prevent the development of an PH when we use a laparoscopic approach.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Barcelona, Spanien, 08035
- Hospital Universitari Valldhebron Research Institute
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients with permanent ostomy and 1 years of life expectancy
- Signed informed consent
Exclusion Criteria:
- Allergy to the compounds of the mesh
- Rejection of the patient
- Rejection of the surgeon
- Field of emergency
- Life expectancy < 1 year
- Prior meshes in the surgical site
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Prophylactic mesh
All patients will have a permanent ostomy and a randomisation with prophylactic mesh
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Lightweight polipropilene and poliglecaprone 25 and oxidized cellulose mesh
Andra namn:
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Inget ingripande: without prophylactic mesh
All patients will have a permanent ostomy and a randomisation without prophylactic mesh
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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If a prophylactic mesh placed through a laparoscopic approach prevents the development of a parastomal hernia when a permanent ostomy is done
Tidsram: 24 to 36 months after surgery
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24 to 36 months after surgery
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Measuring the quality of life using the SF-36
Tidsram: Preoperative and at the end of the study
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Preoperative and at the end of the study
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Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- Serra-Aracil X, Bombardo-Junca J, Moreno-Matias J, Darnell A, Mora-Lopez L, Alcantara-Moral M, Ayguavives-Garnica I, Navarro-Soto S. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia. Ann Surg. 2009 Apr;249(4):583-7. doi: 10.1097/SLA.0b013e31819ec809.
- Lopez-Cano M, Lozoya-Trujillo R, Espin-Basany E. Prosthetic mesh in parastomal hernia prevention. Laparoscopic approach. Dis Colon Rectum. 2009 May;52(5):1006-7. doi: 10.1007/DCR.0b013e31819a6a58.
- Lopez-Cano M, Lozoya-Trujillo R, Quiroga S, Sanchez JL, Vallribera F, Marti M, Jimenez LM, Armengol-Carrasco M, Espin E. Use of a prosthetic mesh to prevent parastomal hernia during laparoscopic abdominoperineal resection: a randomized controlled trial. Hernia. 2012 Dec;16(6):661-7. doi: 10.1007/s10029-012-0952-z. Epub 2012 Jul 11.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PR(AG)116/2006
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