Dissections INTERVENTIONAL

1 May 2009
Evidence-based Medicine for Surgeons

Interrupted or continuous slowly absorbable sutures for closure of primary elective midline
abdominal incisions
Authors: Seiler CM, Bruckner T, Diener MK, et al
Journal: Annals of Surgery 2009; 249:576–582
Centre: Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany
Incisional hernia remains the most common long-term complication after midline incisions of the
abdominal wall. Risk factors can be divided into patient- and surgeon-related. While the former
BACKGROUND cannot be standardized or controlled in most cases, the surgical closure technique and material
can be optimized to lower the incidence of incisional hernias.
Authors' claim(s): “...The incidence of incisional hernias was higher than
RESEARCH QUESTION expected in all groups. In addition, a high frequency of wound infections was
observed. New concepts need to be developed and studied to substantially
Population
reduce the frequency of incisional hernias.”
Patients undergoing elective,
primary, midline laparotomy with
an expected incision length of 15
IN SUMMARY
cm or more. Outcome comparison between the three types of fascial closure

Indicator variable
Interrupted Continuous Continuous
Vicryl® PDSII ® Monoplus ®
Three types of standardized fascial
closure Number randomized 210 205 210
Died during 1 yr 14 10 13
Outcome variable
Lost to follow up  44 31 39
Primary: Occurrence of incisional
hernia within one year of surgery. ITT (intention to treat) 176 174 171
Secondary: Burst abdomen, wound
infection, pulmonary complication. Incisional hernia at 1 yr  28 (15.9%) 15 (8.4%) 22 (12.5%)

Comparison
Wound infection rate  26 (12.7%) 39 (19.4%) 33 (16.3%)

Outcome differences between the

three types of fascial closure. None of the differences between the groups were statistically significant
There were no differences in the rate of burst abdomen and pulmonary
morbidity between the three groups.

THE TISSUE REPORT

The authors point out the high incidence of incisional hernia and the huge wound infection rate despite almost all
patients having received prophylactic antibiotics and all procedures being elective.
The drop out rate in the study is an unacceptable 18%. The authors do not discuss this flaw in their paper.
The Vicryl group was closed by an interrupted technique while the other two used running closure. Evidence exists that
points to the inferiority of interrupted closure over running. The authors provide no reasonable explanation for this choice
of technique. Yet, the Vicryl group had the lowest incisional hernia rate (numerically, though not statistically significant).
Overall, the study raises more questions than it provides answers for. It tells us nothing more than what we have known for
two decades or more: abdominal fascia is best closed by a running, delayed absorbable, monofilament, mass closure
technique.

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 Elective, primary, Emergency  Vicryl PDS II Monoplus
midline laparotomy Under immuno-
Stratified random Target ? ? ?
with an expected suppressive Rx 
Cluster incision length of 15 Chemotherapy Accessible ? ? ?
cm or more  within 2 weeks 
Consecutive Age > 18 yrs  Radiation > 8 wk  Intended 210 205 210
Convenience Survival potential > Coagulopathy  Drop outs 44 31 39
1 yr  Dementia 
Judgmental Study 176 174 171

 = Reasonable | ? = Arguable |  = Questionable

A priori sample size calculation: (significance = 0.05, power = 80%) 172 patients per group
Duration of the study: July 11, 2004 - September 26, 2006

Sampling bias: The drop out rate of 18% is unacceptably high. The authors offer no explanation.

COMPARISON
Randomized Case-control Non-random Historical None

Controls - details
Allocation details The patients were randomized intraoperatively to the 3 fascial closure groups: absorbable
braided material (Vicryl) applied as an interrupted suture, slowly absorbable monofilament
materials, one with longitudinal elasticity (MonoPlus) and one without (PDS II), both as
continuous sutures with a wound length: suture length ratio of 4:1. The technique of closure
was standardized.
Comparability The three groups were similar in demographic characteristics and co-morbidties.
Disparity None reported. No individual analysis of the characteristics of the drop outs is offered.

Comparison bias: The decision to use Vicryl as an interrupted suture and the other two as continuous is
questionable. Evidence exists in support of continuous closures being more secure than interrupted. This renders the
comparisons as biased. The authors provide no explanation for this choice.

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

Device suited to task

Training

Scoring

Blinding
Repetition

Protocols

Y ? N

1.Ultrasound evaluation of incisional hernia Y N ? - - - Y

Measurement bias: The authors give no description of the method by which ultrasound was used to detect incisional
hernia other than the statement: "Incisional hernia was defined as a fascial dehiscence after completed superficial
wound healing with or without a prolapse of abdominal organs, confirmed by abdominal ultrasound."

© Dr Arjun Rajagopalan