Importance Incisional hernia is the most frequent surgical complication
after laparotomy. Up to 30% of all patients undergoing laparotomy
develop an incisional hernia.
Objective To compare laparoscopic vs open ventral incisional hernia repair
with regard to postoperative pain and nausea, operative results, perioperative
and postoperative complications, hospital admission, and recurrence
Design Multicenter randomized controlled trial between May 1999 and
December 2006 with a mean follow-up period of 35 months.
Setting All patients were operated on in a clinical setting at 1 of
the 2 participating university medical centers or at the other 8 teaching
Participants Two hundred six patients from 10 hospitals were randomized equally
to laparoscopic or open mesh repair. Patients with an incisional hernia
larger than 3 cm and smaller than 15 cm, either primary or recurrent,
were included. Patients were excluded if they had an open abdomen
treatment in their medical histories.
Intervention Laparoscopic or open ventral incisional hernia repair.
Main Outcome Measures The primary outcome of the trial was postoperative pain. Secondary
outcomes were use of analgesics, perioperative and postoperative complications,
operative time, postoperative nausea, length of hospital stay, recurrence,
morbidity, and mortality.
Results Median blood loss during the operation was significantly less
(10 mL vs 50 mL; P = .05) as well
as the number of patients receiving a wound drain (3% vs 45%; P < .001) in the laparoscopic group.
Operative time for the laparoscopic group was longer (100 minutes
vs 76 minutes; P = .001). Perioperative
complications were significantly higher after laparoscopy (9% vs 2%).
Visual analog scale scores for pain and nausea, completed before surgery
and 3 days and 1 and 4 weeks postoperatively, showed no significant
differences between the 2 groups. At a mean follow-up period of 35
months, a recurrence rate of 14% was reported in the open group and
18%, in the laparoscopic group (P = .30).
The size of the defect was found to be an independent predictor for
recurrence (P < .001).
Conclusions and Relevance During the operation, there was less blood loss and less need
for a wound drain in the laparoscopic group. However, operative time
was longer during laparoscopy. Perioperative complications were significantly
higher in the laparoscopic group. Visual analog scores for pain and
nausea did not differ between groups. The incidence of a recurrence
was similar in both groups. The size of the defect was found to be
an independent factor for recurrence of an incisional hernia.