Single Incision, MiniPort or convEntional Laparoscopic cholecystectomy for uncomplicated sympthomatic cholecystolithiasis (SIMPEL-trial)

Completed

• Conditions: biliary colic; cholecystolithiasis; 10017998

• Registration Number: NL-OMON36580
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 446

Inclusion Criteria

age 18-75 years
positive history of biliary colic
confirmative ultrasound examination of uncomplicated cholecystolithiasis
Regular bloodtest without signs of infection or cholestasis
Willingness to cooperate with random group assignment, attend office visits and comply with all tests in this protocol
Oral and written Informed Consent

Exclusion Criteria

younger then 18 years
patient who is legally or mentally incapable or unable to give informed consent
history of previous abdominal surgery in the upper abdomen or by midline incision
recent ERCP within 6 weeks of trial
concomitant biliary disease at ultrasound investigation:
o Choledocholithiasis
o Cholecystitis
o Dilatation of intra- or extrahepatic biliary structures
abnormal bloodtest with elevated liverfunction and bilirubin and signs of infection (elevated CRP, leucocytes or sedimentation)
contraindications to general anaesthesia or abdominal surgery including ASA >3
pregnancy at time of inclusion or at time of surgery
immunosuppresion
coagulation disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Combined endpoint including safety scored by photo or video of the critical<br /><br>view of safety and all major complications (injury of common bile duct). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>per and postoperatieve complications:<br /><br>- painscore, scored by the VAS score<br /><br>- use of painkillers.<br /><br>- woundinfcetion<br /><br>- bilioma<br /><br>- bile duct lesion<br /><br>- trocarhernia<br /><br>- tissue damage, as measured by interleukines<br /><br>- scoring of scar</p><br>