Laparoscopic vs. open incisional hernia repair: a randomized clinical trial.

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 rate.

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 hospitals.

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.