Midline versus transverse incision in major abdominal surgery: a randomized, double-blind equivalence trial (POVATI: ISRCTN60734227).
OBJECTIVE
There are 2 main types of access for patients requiring major open, elective abdominal surgery: the midline or the transverse approach. The aim of this study is to compare both approaches by focusing on postoperative pain, complications, and frequency of incisional hernias.


BACKGROUND
A recent Cochrane review suggested that transverse incisions may be less painful but incisional hernia rates do not differ.


METHODS
Randomized, patient- and observer-blinded, monocentric, equivalence clinical trial. Patients were scheduled for elective primary abdominal incisions. Composite primary end point measured 48 hours after surgery was the total amount of analgesics (piritramide) required in the last 24 hours and pain (Visual Analogue Scale). Secondary end points were early-onset and late complications. This study is registered in the ISRCTN registry and has the ID number ISRCTN60734227.


RESULTS
Two hundred patients (101 midline and 99 transverse) were randomized. Both incision types resulted in similar amounts of required analgesics (95% confidence interval [-0.38; -0.33] was included in the equivalence level). For the Visual Analogue Scale, both the 95% and 90% CI (0-10) were neither within the equivalence levels nor were their differences significant at the 5% level. No relevant differences between midline and transverse incisions were observed for 30-day mortality (2 vs. 2, P = 0.99), mortality after one year (15 vs. 23, P = 0.15), pulmonary complications (13 vs. 17, P = 0.43), median length of hospital stay (11 vs. 12 days, P = 0.08), median time to tolerance of solid food (12 vs. 14 days, P = 0.30), and incisional hernias after one year (13 vs. 8, P = 0.48). More wound infections occurred in the transverse group (15 vs. 5, P = 0.02).


CONCLUSIONS
The decision about the incision should be driven by surgeon preference with respect to the patient's disease and anatomy.
Seiler
Christoph M
CM
Department of General, Visceral, and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany.
Deckert
Andreas
A
Diener
Markus K
MK
Knaebel
Hanns-Peter
HP
Weigand
Markus A
MA
Victor
Norbert
N
Büchler
Markus W
MW
D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control*; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D006555:Hernia, Ventral / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D007813:Laparotomy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control*; D010892:Pirinitramide / Q000627:therapeutic use; D013530:Surgical Wound Infection / Q000209:etiology / Q000517:prevention & control*; D013536:Suture Techniques
D000701:Analgesics, Opioid; D010892:Pirinitramide