Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.
Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.
Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.
In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.
The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Vaud
-
Lausanne, Vaud, Schweiz, 1011
- Department of Visceral Surgery, University Hospital Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of midline abdominal wall incisional hernia
- Adults of 20 to 80 years old
- ASA I to III
- Inform consent signed by the patient and investigators
Exclusion Criteria:
- Incisional hernia less than 2 cm
- Groin hernia
- Antibiotic treatment before and during hospital admission
- Emergency admission for strangulated incisional hernia
- Immunosuppressing treatment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Drain
|
Rives-Stoppa repair of incisional hernia
|
|
Andet: No drain
|
Rives-Stoppa repair of incisional hernia
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.
Tidsramme: 30 days
|
30 days
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Nicolas Demartines, MD, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DP-2007-CHV-UNIL
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