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Early or delayed laparoscopic cholecystectomy after endoscopic sphincterotomy for combined choledochocystolithiasis. A prospective randomised trial.


- candidate number2140
- NTR NumberNTR710
- ISRCTNISRCTN42981144
- Date ISRCTN created21-jul-2006
- date ISRCTN requested19-jul-2006
- Date Registered NTR21-jun-2006
- Secondary IDsN/A 
- Public TitleEarly or delayed laparoscopic cholecystectomy after endoscopic sphincterotomy for combined choledochocystolithiasis. A prospective randomised trial.
- Scientific TitleEarly or delayed laparoscopic cholecystectomy after endoscopic sphincterotomy for combined choledochocystolithiasis. A prospective randomised trial.
- ACRONYMLANS
- hypothesisEarly laparoscopic cholecystectomy after endoscopic sphincterotomy for combined cholecystodocholithiasis, leads to less conversions as compared to laparoscopic cholecystectomy 6-8 weeks after sphincterotomy, and thus reduces morbidity and hosptal stay.
- Healt Condition(s) or Problem(s) studiedCholecystodocholithiasis
- Inclusion criteria1. Proven CBD stones; 2. Proven gallbladder stones; 3. Successful sphincterotomy and stone extraction; 4. Patients older than 18 years of age; 5. Informed consent.
- Exclusion criteria1. Biliary pancreatitis; 2. Acute cholecystitis; 3. ASA IV and V patients.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 9-jun-2006
- planned closingdate1-jan-2008
- Target number of participants96
- InterventionsPatients will be randomised to undergo either early (within 3 days) or late (after 6-8 weeks) cholecystectomy.
- Primary outcomeNumber of conversions to open cholecystectomy.
- Secondary outcome1. Length of operation; 2. Postoperative pain and performance scale; 3. Complications of cholecystectomy; 4. Hospital stay; 5. Time until professional rehabilitation.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. D. Boerma
- CONTACT for SCIENTIFIC QUERIESMD. D. Boerma
- Sponsor/Initiator St Antonius Hospital, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
St Antonius Hospital, Nieuwegein
- PublicationsN/A
- Brief summaryThis is a randomised trial among patients who are scheduled to undergo laparoscopic cholecystectomy after endoscopic sphincterotomy for combined choledochocystoloithiasis. Nowadays, in most countries, surgery is planned 6 to 8 weeks after sphincterotomy. In over 20% of these patients the laparoscopic operation is converted to open surgery, whereas in patients who undergo laparoscopic cholecystectomy for uncomplicated symptomatic gallstones, conversion is necessary in only 5% of patients. The hypothesis of this trial is that the high conversion-rate in these patients can be lowered by performing the operation shortly after sphincterotomy, i.e. within 3 days. Patients who undergo successfull sphincterotommy for CBD stones, and who have residual stones in the gallbladder, will be randomised to undergo either early (within 3 days) or late (after 6-8 weeks) cholecystectomy. Primary endpoint is the number of conversions in both groups.
- Main changes (audit trail)
- RECORD21-jun-2006 - 24-jul-2006


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