Laparoscopic vs Open Incisional Hernia Repair: A Randomized Clinical Trial
Hasan H. Eker, MD; Bibi M. E. Hansson, MD, PhD; Mark Buunen, MD; Ignace M. C. Janssen, MD, PhD; Robert E. G. J. M. Pierik, MD, PhD; Wim C. Hop, MSc, PhD; H. Jaap Bonjer, MD, PhD; Johannes Jeekel, MD, PhD; Johan F. Lange, MD, PhD
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.
Incisional hernia is the most frequent surgical complication after laparotomy. Up to 30% of all patients undergoing laparotomy develop an incisional hernia. This is associated with discomfort, pain, respiratory restriction, and dissatisfactory cosmetic results.1- 6 The associated morbidity often results in subsequent hernia repair.7,8 Although significant improvements have been achieved in the field of incisional hernia concerning operative technique and the use of prosthetic materials, recurrence rates remain high at 32% to 63%.9 Risk factors associated with recurrence, such as hernia size, unfortunately cannot be influenced.10 The quest for more effective and less invasive techniques continues.
The introduction of minimally invasive surgery in the early 1990s enabled the possibility of laparoscopic incisional hernia repair.11 Laparoscopy has proved to be a safe, effective, efficient, and less painful technique for many types of surgery and has become the current “gold standard” for cholecystectomy, for example.12 Laparoscopic incisional hernia repair is a widely used and accepted operative technique, assuming general advances of laparoscopy are also valid for this group. Recent studies have shown that in the short term laparoscopic repair is superior to open repair in terms of less blood loss, fewer perioperative complications, and shorter hospital stay.13,14 Long-term outcomes such as recurrence rates are yet unknown. So far, level 1 randomized clinical trials for benefits or disadvantages of laparoscopic incisional hernia repair are scarce.15
The ongoing debate about the expected merits of laparoscopic vs open incisional hernia repair prompted the need for a level 1 randomized controlled trial. The aim of this study was to compare laparoscopic vs open ventral incisional hernia repair with regard to postoperative pain and nausea, operative time, blood loss, perioperative and postoperative complications, length of hospital stay, and recurrence rates.
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