MedPath

aparo- Endoscopic Single site Surgery vs Conventional Laparoscopic Removal of the Gall Bladder

Not yet recruiting
Conditions
Gallbladder removal
Symptomatic Gallstones
10019818
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
NameTimeMethod
<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
NameTimeMethod
<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>
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