Skip to content

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

Single Incision, MiniPort or convEntional Laparoscopic cholecystectomy for uncomplicated sympthomatic cholecystolithiasis (SIMPEL-trial) - SILS vs miniport cholecystectomy versus laparoscopic cholecystectomie

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36580
Enrollment
446
Registered
2011-07-04
Start date
2013-10-10
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary colic cholecystolithiasis

Interventions

the study consists of 3 treatment modalitities: -conventionele laparoscopic cholecystectomy - miniport / needlescopic laparoscopic cholecystectomy - single port laparoscopic cholecystectomy

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Combined endpoint including safety scored by photo or video of the critical view of safety and all major complications (injury of common bile duct).

Secondary

MeasureTime frame
per and postoperatieve complications: - painscore, scored by the VAS score - use of painkillers. - woundinfcetion - bilioma - bile duct lesion - trocarhernia - tissue damage, as measured by interleukines - scoring of scar

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)