Dissections INTERVENTIONAL

6 July 2009
Evidence-based Medicine for Surgeons

Midline versus transverse incision in major abdominal surgery: A randomized, double-blind

equivalence trial
Authors: Seiler CM, Deckert A, Diener MK, et al
Journal: Annals of Surgery 2009; 249: 913–920
Centre: University of Heidelberg, Heidelberg, Germany
Midline and transverse incisions are widely used in abdominal surgery; the choice is usually based
on the surgeon's preference. Relevant outcomes that may guide the choice of incision are the
BACKGROUND incidence of postoperative complications (burst abdomen, pulmonary complications, wound
infection, incisional hernia) and the time taken to open and close the abdomen. Pain and return
to normal activities in the short-term, and cosmetics in the long-term, may also be of interest.

RESEARCH QUESTION IN SUMMARY

Population Midline vs transverse laparotomy incisions
A series of patients undergoing Midline Transverse
elective primary laparotomy for
stomach, colonic and pancreatic Number randomized 101 99
procedures. (The Postsurgical Pain
Primary end points (pts) 70 64
Outcome of Vertical and
Transverse Abdominal Incision Pain intensity (VAS) 13 17
(POVATI) trial )
Analgesic usage (mg/hr) 1.08 1.04
Indicator variable Secondary end points (pts) 96 97
Midline and transverse incisions. Wound infection 5 15 *
Outcome variable Burst abdomen 0 1
Primary: Analgesic usage and pain Pulmonary complications 13 17
intensity. Secondary: frequencies
Procedure time (hrs) 4.2 4.1
of early-onset complications (burst
abdomen, pulmonary events, Mortality 2 2
wound infections) and late-onset
complications (incisional hernias Incisional hernia at 1 yr 13 (of 79) 8 (of 69)
after one year). * p = 0.02
None of the other differences were statistically significant
Comparison Authors' claim(s): “... According to the results of [this trial]... both
As described above. incision types can be used without any relevant consequences for the
patient.”

THE TISSUE REPORT

There are too many flaws in this trial. The drop off in numbers between the accessible, intended (after applying inclusion/
exclusion criteria) and final study population is large. The decision to use a single measurement on the 2nd postoperative
day (and the total analgesic usage as the dosage used within 24 hours of the VAS measurement) as the sole index of pain
intensity seems very arbitrary. The study is peppered with misuse of terms and liberal interpretations of methodological
concepts. There is too much post-hoc slicing of the pie in presenting study numbers. The intention to treat process
excludes drop outs from the original cohort - a clear contravention of definitions. To cap it all, an incisional hernia rate of
12-16% at one year is alarming. And, oh by the way, how do you double blind surgical procedures like the title claims?

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
Interesting l | 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 Elective primary Recurrent opening of Midline Transverse
laparotomy for the abdominal wall ?
Stratified random Target ? ?
stomach, colonic and Certain procedures
Cluster pancreatic procedures (liver, gallbladder, Accessible 1188
suitable for both spleen, and rectum) 
Consecutive incisions  Intended 101 99
Convenience Life expectancy > Drop outs See below
than one year 
Judgmental Study
Primary end point 70 64
20 end point - 30 days 97 96
20 end point - 1 year 79 69

 = Reasonable | ? = Arguable |  = Questionable

Duration of the study: February 2007 to October 2007

Sampling bias: The sampling process is seriously flawed. The drop off in numbers between the accessible and
intended population (after applying inclusion/ exclusion) criteria and the final study population is large. Excluding
"certain procedures (liver, gallbladder, spleen and rectum)" is cause for concern. The authors perform a post-hoc pie
slicing of the study population that is dubious. Their "intention to treat" methodology is unconventional: it excludes
drop-outs after randomization.

COMPARISON
Randomized Case-control Non-random Historical None

Controls - details
Allocation details The closure method was standardized with a continuous, mass, all-layer closure using 2 Mono
Plus loops starting at both edges of the incision, with a 4:1 ratio (suture:incision length). Both
rectus muscles were divided uniformly in the transverse group. Neither a subcutaneous drain
nor a subcutaneous suture was used. The skin was closed with staples.

Postoperative analgesia was standardized with a dosage of 1mg/mL Piritramide through a

patient-controlled pump.
Comparability Study groups were comparable for all patient and procedure characteristics and also within the
different surgical categories
Disparity -

Comparison bias: The groups appear well matched and comparable.

MEASUREMENT
Measurement error
Device used Device error Observer error
Gold std.
Repetition

Protocols

Device suited to task

Training

Scoring

Blinding

Y ? N

1.Pain intensity (Visual Analogue Scale - 1-100) Y N Y Y Y Y Y

Abdominal pain intensity at was rest measured on a scale from 0 to 100 with the Visual Analogue Scale (VAS) at day 2
postoperatively and the total amount of analgesics required (Piritramide mg/L) within 24 hours before VAS
measurement after surgery.
At least an abdominal wall ultrasonography (or computer tomography or magnetic resonance imaging if performed for
reevaluation of underlying disease) was used for assessment of incisional hernias.
Measurement bias: The decision to use a single measurement on the 2nd postoperative day and the total analgesic
usage as the dosage used within 24 hours of the VAS measurement seems very arbitrary. There is no satisfying
explanation offered for this specific choice rather than a mean or average of some sort from the whole postoperative
period.
© Dr Arjun Rajagopalan