Short-term Outcomes for Open and Laparoscopic Midline Incisional Hernia Repair A Randomized Multicenter Controlled Trial: The ProLOVE (Prospective Randomized Trial on Open Versus Laparoscopic Operation of Ventral Eventrations) Trial

Objective: The aim of the trial was to compare laparoscopic technique with open technique regarding short-term pain, quality of life (QoL), recovery, and complications. Background: Laparoscopic and open techniques for incisional hernia repair are recognized treatment options with pros and cons. Methods: Patients from 7 centers with a midline incisional hernia of a maximum width of 10 cm were randomized to either laparoscopic (LR) or open sublay (OR) mesh repair. Primary end point was pain at 3 weeks, measured as the bodily pain subscale of Short Form-36 (SF-36). Secondary end points were complications registered by type and severity (the Clavien-Dindo classification), movement restrictions, fatigue, time to full recovery, and QoL up to 8 weeks. Results: Patients were recruited between October 2005 and November 2009. Of 157 randomized patients, 133 received intervention: 64 LR and 69 OR. Measurements of pain did not differ, nor did movement restriction and postoperative fatigue. SF-36 subscales favored the LR group: physical function (P < 0.001), role physical (P < 0.012), mental health (P < 0.022), and physical composite score (P < 0.009). Surgical site infections were 17 in the OR group compared with 1 in the LR group (P < 0.001). The severity of complications did not differ between the groups (P < 0.213). Conclusions: Postoperative pain or recovery at 3 weeks after repair of midline incisional hernias does not differ between LR and OR, but the LR results in better physical function and less surgical site infections than the OR does. (ClinicalTrials.gov Identifier: NCT00472537)