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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

Rogmark, Peder MD*; Petersson, Ulf MD, PhD*; Bringman, Sven MD, PhD; Eklund, Arne MD, PhD; Ezra, Emmanuel MD§; Sevonius, Dan MD; Smedberg, Sam MD, PhD; Österberg, Johanna MD, PhD**; Montgomery, Agneta MD, PhD*

doi: 10.1097/SLA.0b013e31828fe1b2
Randomized Controlled Trials

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. ( Identifier: NCT00472537)

One hundred thirty-three randomized patients with 8-weeks follow-up were assessed for pain, quality of life, and recovery and surgical complications. Postoperative pain after 3 weeks did not differ, but laparoscopic repair resulted in better physical function and less surgical site infections compared with open repair when applied on medium-sized midline incisional hernias. Quality of life increased for all patients.

*Department of Surgery, Skåne University Hospital (Malmö), Malmö, Sweden

CLINTEC, Karolinska Institutet, Stockholm, Sweden, and Department of Surgery, Södertälje Hospital, Södertälje, Sweden

Department of Surgery, Västerås Hospital, Västerås, Sweden

§Department of Surgery, Arvika Hospital, Arvika, Sweden

Department of Surgery, Skåne University Hospital (Lund), Lund, Sweden

Department of Surgery, Helsingborg Hospital, Helsingborg, Sweden

**Department of Surgery, Mora Hospital, Mora, Sweden.

Reprints: Peder Rogmark, MD, Department of Surgery, Skåne University Hospital, SE-205 02, Malmö, Sweden. E-mail:

Presented at the European Hernia Society Meeting 2010 in Istanbul, Turkey, and at the Swedish Surgical Society Meeting 2010 in Gothenburg, Sweden.

Disclosure: Supported by funding from Lund University, Region Skåne Research & Development Funds, Ethicon, Johnson & Johnson Medical Ltd., The Einar and Inga Nilsson Foundation, The Anna Lisa and Sven-Eric Lundgren Foundation, and The Crafoord Foundation. The authors declare no conflicts of interest.

© 2013 by Lippincott Williams & Wilkins.