Dissections INTERVENTIONAL

8 July 2009
Evidence-based Medicine for Surgeons

Is there a role for drain use in elective laparoscopic cholecystectomy? A controlled

randomized trial
Authors: Tzovaras G, Liakou P, Fafoulakis F, et al
Journal: The American Journal of Surgery 2009; 197: 759-763
Centre: Department of Surgery, University Hospital of Larissa, Larissa, Greece
Most well-designed trials have failed to demonstrate any benefit from drainage in open
cholecystectomy. Some of them even suggest that drainage in cholecystectomy patients might be
BACKGROUND harmful. Many surgeons extrapolate the results of trials in open cholecystectomy to the
laparoscopic approach. There is a lack of good evidence regarding the usefulness of drainage in
elective laparoscopic cholecystectomy.

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.”

THE TISSUE REPORT

Although large numbers are presented, the trial is based on the experience of one surgeon. The decision to use a passive
drain might not be considered acceptable in view of the recommendations for closed suction drainage of the peritoneal
cavity, if drainage is to be used at all. Details regarding analgesic usage are skimpy.

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

The devil is in the details (more on the paper) ... 

© 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

 = Reasonable | ? = Arguable |  = Questionable

* - protocol violations but handled on an "intention-to-treat" basis
Duration of the study: January 2002 to December 2006
Sample size of 276 patients/randomization arm was calculated on an expected 10% difference in morbidity with a
power of 80% to detect this difference at the 5% level.

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.

Device suited to task

Training

Scoring

Blinding
Repetition

Protocols

Y ? N

1.Postoperative pain - Visual analogue score (VAS) Y N Y N N Y N

Measurement bias: Details of analgesia provided are not mentioned.

© Dr Arjun Rajagopalan