BIOLAP: Biological versus synthetic mesh in laparoscopic hernia repair-a randomized multicenter, prospective, self-controlled clinical trial
Not Applicable
- Conditions
- K40.2Bilateral inguinal hernia, without obstruction or gangrene
- Registration Number
- DRKS00010178
- Lead Sponsor
- niversität Witten/Herdecke, vertreten durch ZKS-UW/H
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 525
Inclusion Criteria
1. Male or female patient at an age of 18 years or older
2. Primary, bilateral hernias
3. Patient eligible for laparoscopic hernia repair
4. Written informed consent
Exclusion Criteria
1. Recurrent hernia
2. Incarcerated hernia
3. Presence of any acute systemic infection
4. Expected non-compliance with any study-related requirement
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The unit of analysis is the hernia, not the patient. The study has two primary endpoints.<br>1. Incidence of postoperative local pain at the hernia site at six months after operation measured with a visual analogue scale (VAS 0-10)<br>2. Incidence of recurrent hernia within the first two years after operation<br>The total duration of follow-up per patient will be 2 years. <br>Intended trial visits: PRE = pre-operative assessment; OP = surgical procedure; F-1W, F-6M, F-12M, F-24M: clinical follow-up visit and assessment of endpoints at one week, six months, one year and two years after surgery. Scope of the follow-up visits: clinical examination, evaluation of pain (VAS on each side), complications, patient satisfaction, and recurrence. If a hernia recurrence was suspected, a verification with ultra-sound or MR or CT-scan will be performed.<br>
- Secondary Outcome Measures
Name Time Method -prevalence and intensity of local pain at other time points (one week and one year postoperatively)<br>- early recurrences within the first year after surgery<br>-wound infection<br>-hematoma<br>-seroma<br>- patient satisfaction (overall results, foreign body sensation, paraesthesia)<br>Intended trial visits: PRE = pre-operative assessment; OP = surgical procedure; F-1W, F-6M, F-12M, F-24M: clinical follow-up visit and assessment of endpoints at one week, six months, one year and two years after surgery. Scope of the follow-up visits: clinical examination, evaluation of pain (VAS on each side), complications, patient satisfaction, and recurrence. If a hernia recurrence was suspected, a verification with ultra-sound or MR or CT-scan will be performed.