Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370344
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2006-08-30
Brief Title:
Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
An Expertise-based Randomized Controlled Trial Comparing Minilaparotomy Cholecystectomy and Laparoscopic Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial compares minilaparotomy small-incision cholecystectomy with key-hole laparoscopic cholecystectomy by randomly allocating patients with gallbladder disease to two groups of surgeons each group being trained for one of the two methods
Detailed Description:
Small-incision open cholecystectomy minilaparotomy for gallbladder disease has been proven superior to conventional open cholecystectomy However it was rapidly overshadowed by laparoscopic cholecystectomy when the latter method was introduced Today some 25 of all gallbladder surgery is done with the conventional open cholecystectomy often on elderly and frail patients Previous trials comparing minilaparotomy and laparoscopic cholecystectomy have been hampered by surgeons different expertise with the two methods These studies indicate that operation time is shorter and that health care cost is lower for minilaparotomy compared to laparoscopic cholecystectomy but hard data are scarce The objective of the present trial is to randomize eligible patients to two groups of surgeons well trained in either minilaparotomy cholecystectomy or laparoscopic cholecystectomy Surgeons in the minilaparotomy group will consider extension of the incision when necessary and surgeons in the laparoscopic group will aim for laparoscopic cholecystectomy with conversion to open cholecystectomy if this is indicated The design of the study allows wide inclusion criteria for participants a cost-utility approach in the analysis and a high external validity of the conclusions reached
Comparison Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease
Comparison Minilaparotomy cholecystectomy compared to laparoscopic cholecystectomy for gallbladder disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None