No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of conversions to open cholecystectomy.
Secondary outcome
1. Length of operation;
2. Postoperative pain and performance scale;
3. Complications of cholecystectomy;
4. Hospital stay;
5. Time until professional rehabilitation.
Background summary
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.
Study objective
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.
Intervention
Patients will be randomised to undergo either early (within 3 days) or late (after 6-8 weeks) cholecystectomy.
P.O. Box 2500
D. Boerma
Nieuwegein 3430 EM
The Netherlands
djamilaboerma@hotmail.com
P.O. Box 2500
D. Boerma
Nieuwegein 3430 EM
The Netherlands
djamilaboerma@hotmail.com
Inclusion criteria
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.
Exclusion criteria
1. Biliary pancreatitis;
2. Acute cholecystitis;
3. ASA IV and V patients.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL649 |
NTR-old | NTR710 |
Other | : N/A |
ISRCTN | ISRCTN42981144 |