Single Incision, MiniPort or convEntional Laparoscopicsurgery for uncomplicated sympthomaticcholecystolithiasis (SIMPEL-trial).
- Conditions
- uncomplicated symptomatic cholecystolithiasis
- Registration Number
- NL-OMON28399
- Lead Sponsor
- VU MC Amsterdam and MUMC+ Maastricht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 446
Inclusion Criteria
1. Age 18-75 years;
2. Patients with positive history and confirmative ultrasound examination of uncomplicated cholecystolithiasis during pre-operative examination;
Exclusion Criteria
1. Patients younger then 18 years and older then 75 years;
2. Patient who is legally or mentally incapable or unable to give informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Critical view of safety;<br /><br>2. Common bile duct inury.
- Secondary Outcome Measures
Name Time Method 1. Duration of surgery;<br /><br>2. Duration fo admission (hours);<br /><br>3. Blood loss;<br /><br>4. Conversion to extra ports;<br /><br>5. Biliary leak;<br /><br>6. Postoperative wound infection;<br /><br>7. Postoperative stress respons (interleukines);<br /><br>8. Cosmesis;<br /><br>9. Lenghth of incision(s);<br /><br>10. Pain;<br /><br>11. Trocar herniation;<br /><br>12. Postoperative regain of functionality.