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


- candidate number10422
- NTR NumberNTR3100
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-okt-2011
- Secondary IDsNL31701.029.11 CCMO
- Public TitleSingle Incision, MiniPort or convEntional Laparoscopic surgery for uncomplicated sympthomatic cholecystolithiasis (SIMPEL-trial).
- Scientific TitleSingle Incision, MiniPort or convEntional Laparoscopic surgery for uncomplicated sympthomatic cholecystolithiasis (SIMPEL-trial).
- ACRONYMSIMPEL
- hypothesisSingle incision laparoscopic cholecystectomy and miniport cholecystectomy are at least as safe and feasable as conventional multiport laparoscopic cholecystectomy.
- Healt Condition(s) or Problem(s) studiedUncomplicated symptomatic cholecystolithiasis
- Inclusion criteria1. Age 18-75 years;
2. Patients with positive history and confirmative ultrasound examination of uncomplicated cholecystolithiasis during pre-operative examination;
3. Regular and complete ultrasound investigation and blood work;
4. Willingness to cooperate with random group assignment, attend office visits and comply with all tests in this protocol;
5. Oral and written Informed Consent (IC).
- Exclusion criteria1. Patients younger then 18 years and older then 75 years;
2. Patient who is legally or mentally incapable or unable to give informed consent;
3. History of previous abdominal surgery in the upper abdomen or by midline incision;
4. Recent ERCP within 6 weeks of trial;
5. Concomitant biliary disease at ultrasound investigation:
A. Choledocholithiasis;
B. Cholecystitis;
C. Dilatation of intra- or extrahepatic biliary structures;
D. Active inflammation with increased infection parameters of:
i. CRP of > 8.0 mg/L;
ii. WBC of > 10.0 x 109/L;
iii. ESR of > 10 mm/ hour.
E. Raised liver enzymes:
i. ASAT of > 35 U/L;
ii. ALAT of > 35 U/L;
iii. Bilirubine of > 20 uMol/L;
iiii. GGT of > 55 U/L;
iiiii. AF of > 120 uMol/L.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2011
- planned closingdate31-okt-2013
- Target number of participants446
- InterventionsLaparoscopic cholecystectomy, 3 arms of intervention:
1. Single port;
2. Miniport;
3. Conventional multiport.
- Primary outcome1. Critical view of safety;
2. Common bile duct inury.
- Secondary outcome1. Duration of surgery;
2. Duration fo admission (hours);
3. Blood loss;
4. Conversion to extra ports;
5. Biliary leak;
6. Postoperative wound infection;
7. Postoperative stress respons (interleukines);
8. Cosmesis;
9. Lenghth of incision(s);
10. Pain;
11. Trocar herniation;
12. Postoperative regain of functionality.
- TimepointsStart inclusion november 2011.
1. Inclusion period 12 months;
2. Follow-up period: 1 year after inclusion.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. D.A. Dam, van
- CONTACT for SCIENTIFIC QUERIESDrs. S. Fransen
- Sponsor/Initiator VU University Medical Center, Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryThe SIMPEL-trial is a multicentre prospective randomised controlled trial, comparing the safety and efficacy of single port laparoscopy, miniport laparoscopy and conventional laparoscopy for uncomplicated symptomatic cholecystolithiasis.
- Main changes (audit trail)
- RECORD10-okt-2011 - 21-okt-2011


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