aparo- Endoscopic Single site Surgery vs Conventional Laparoscopic Removal of the Gall Bladder
Not yet recruiting
- Conditions
- Gallbladder removalSymptomatic Gallstones10019818
- Registration Number
- NL-OMON34133
- Lead Sponsor
- Alysis Zorggroep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Patient on waitinglist for laparoscopic gallbladder removal
Age between 18 and 70 years
BMI< 35 kg/m2
Exclusion Criteria
In Prior history; Cholecystitis, ERCP, Upper GI surgery, other liver disease, Cancer in upper GI trackt, Alcohol or substance abuse
Participation in other research
Psychiatric condition
Unability to comply to study criteria
Patients without social network/ unable to care for themselves
Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main objective research<br /><br>Investigate whether a significant difference in pain (VAS score) between the<br /><br>conventional laparoscopic approach and the approach for a gallbladder removal<br /><br>LESS<br /><br><br /><br>Either VAS scores</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary goals<br /><br>a. Explore the possibility of a significant difference in abdominal and<br /><br>umbilical rupture between the different approaches<br /><br>b. Investigate whether a significant difference in wound infection between the<br /><br>different approaches.<br /><br>c. Investigate whether a difference in patient satisfaction as to the final<br /><br>outcome between the different approaches.<br /><br>d. Investigate whether there is a difference in overall complications between<br /><br>the different approaches<br /><br>e. Investigate whether there is a difference in operative time<br /><br>f. Investigate whether there is a difference in treatment costs<br /><br><br /><br>Either outcome echoes observations infection outcome, VAS score</p><br>