Early 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…
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of conversions to open cholecystectomy.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
Early 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.
Onderzoeksproduct en/of interventie
Patients will be randomised to undergo either early (within 3 days) or late (after 6-8 weeks) cholecystectomy.
Publiek
P.O. Box 2500
D. Boerma
Nieuwegein 3430 EM
The Netherlands
djamilaboerma@hotmail.com
Wetenschappelijk
P.O. Box 2500
D. Boerma
Nieuwegein 3430 EM
The Netherlands
djamilaboerma@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Proven CBD stones;
2. Proven gallbladder stones;
3. Successful sphincterotomy and stone extraction;
4. Patients older than 18 years of age;
5. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Biliary pancreatitis;
2. Acute cholecystitis;
3. ASA IV and V patients.
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL649 |
NTR-old | NTR710 |
Ander register | : N/A |
ISRCTN | ISRCTN42981144 |