Characteristics of included studies [ordered by study ID]
|Methods||Randomised clinical trial (parallel study design)|
Number randomised: 24.
Mean age: 48 years.
Females: 0 (0%).
Patients with incisional hernia following stoma closure.
|Interventions||Participants were randomly assigned to two groups.|
Group 1: Electrified drain (n = 12).
Group 2: Corrugated drain (n = 12).
Co-interventions: all patients had a three day course of antibiotics post-operatively.
All were tissue repairs.
|Outcomes||1. Infection (>10,000 organisms per ml in culture of swab from drain site).|
2. Clinical infection (redness, oedema and purulent discharge).
3. Need for additional course of antibiotics.
|Notes||Contacted author to obtain information regarding allocation sequence, allocation concealment, blinding and hospital stay.|
|Risk of bias|
|Bias||Authors' judgement||Support for judgement|
|Random sequence generation (selection bias)||Low risk||Quote: "Random number table" (author replies).|
|Allocation concealment (selection bias)||Unclear risk||Comment: This information could not be obtained.|
|Blinding of participants and personnel (performance bias) |
|High risk||Quote: "Participants and outcome assessors were blinded by use of dummy electrodes".|
Comment: The surgeons were not blinded to the groups.
|Blinding of outcome assessment (detection bias) |
|Low risk||Quote: "Participants and outcome assessors were blinded by use of dummy electrodes".|
Comment: Since the participants or the outcome assessors could not determine whether the drain was electrified, they were adequately blinded.
|Incomplete outcome data (attrition bias) |
|Low risk||Comment: There were no drop-outs or withdrawals after randomisation (author replies).|
|Selective reporting (reporting bias)||Low risk||Comment: Important primary outcome namely wound infection was reported.|
|No bias due to source of funding?||Unclear risk||Comment: The source of funding was not stated.|
Characteristics of ongoing studies [ordered by study ID]
|Trial name or title||Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?|
|Methods||Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study|
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
Incisional hernia less than 2 cm
Antibiotic treatment before and during hospital admission
Emergency admission for strangulated incisional hernia
|Interventions||Insertion of three drains (Redon)|
|Outcomes||Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings at 30 days|
|Starting date||May 2007|
|Contact information||Alexandre Paroz, MD|
Department of Visceral Surgery, University Hospital Center, Lausanne, Vaud, 1011
telephone: +41 21 314 52 34
Comparison 1. Electrified drain vs corrugated drain