Beruflich Dokumente
Kultur Dokumente
8 July 2009
Evidence-based Medicine for Surgeons
IN SUMMARY
RESEARCH QUESTION
Drainage after elective laparoscopic cholecystectomy
Population
Drain No drain
A single surgeon's experience with
patients undergoing elective Number 284 281
laparoscopic cholecystectomy. Operative details
Indicator variable Operating time (minutes) 45 43
Drainage of the subhepatic space Conversions 4 3
after completion of the procedure.
Hospital stay 1 day 1 day
Outcome variable Mortality 0 0
Primary: Postoperative pain, Morbidity
mortality, bile leak, collection, and
other procedure-related morbidity. Postoperative pain score 5 3*
Bile leak 4 2
Comparison
Collection 2 1
Patients who were not drained
after surgery. Bleeding 2 2
* - p = 0.001
Authors' claim(s): “...The routine use of a drain in elective laparoscopic cholecystectomy has nothing to
offer; in contrast, it is associated with increased pain ... [though]providing a false sense of security, does not
guarantee either prevention or treatment of postoperative bile collections, bleeding, or bile peritonitis.”
EBM-O-METER
Evidence level Overall rating Bias levels
Double blind RCT Sampling
Randomized controlled trial (RCT) Comparison
Trash Swiss Safe News-
Prospective cohort study - not randomized cheese worthy Measurement
Life's too Holds water
short for this Full of holes “Just do it”
Case controlled study
Interestingl | Novel l | Feasible l
Case series - retrospective Ethical l | Resource saving l
© Dr Arjun Rajagopalan
SAMPLING
Sample type Inclusion criteria Exclusion criteria Final score card
Simple random All patients Acute cholecystitis, Drain No drain
undergoing elective cholangitis, or
Stratified random Target ?
laparoscopic pancreatitis
Cluster cholecystectomy Did not require Accessible ?
ASA grades I-III common bile duct
Consecutive exploration or any Intended 284 281
Convenience other additional Drop outs 0 3*
procedure
Judgmental Study 284 281
Sampling bias: The study, though large and adequately powered, represents the experience of a single surgeon
from Greece.
COMPARISON
Randomized Case-control Non-random Historical None
Controls - details
Allocation details Eligible patients were randomized into 2 groups: one group received a gravity drain in the
subhepatic space, and the other received no drain. The drain used was a gravity (no suction)
corrugated silicone drain tailored to a width of approximately 4 mm, inserted through a lateral
5-mm trocar. The external portion of the drain was fit into a simple colostomy bag. When a
drain was used, it was removed 24 hours after surgery unless there was bile (any amount) or
>100 mL of blood in the drain bag. The randomization arm was only notified to the operating
team after the completion of cholecystectomy.
Comparability The groups were comparable regarding demographics and other perioperative characteristics.
Disparity -
Comparison bias: The choice of a passive drain (corrugated silicone) is not in keeping with current
recommendations for drainage of the peritoneal cavity: closed, suction catheters.
MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.
Scoring
Blinding
Repetition
Protocols
Y ? N
© Dr Arjun Rajagopalan