Quality of life in men with inguinal hernia and outcome after three different mesh techniques

Inguinal hernia repair (IHR) is a very common surgical procedure with approximately 16 000 procedures performed every year in Sweden. Previously, recurrence after IHR was a major concern, but with the introduction of the use of a synthetic mesh, recurrence rates are low today (1-2%). One remaining clinical problem is that some patients develop chronic inguinal pain after IHR, which is associated with impaired quality of life (QoL). The mechanism behind development of chronic pain is not fully understood. New mesh materials and designs are continuously being introduced with the aim of improving results after IHR. In paper I, 309 male patients scheduled for IHR under LA and daycare surgery were randomized to one of three different mesh repairs; Lichtenstein (L), Prolene Hernia System (PHS) and UltraPro Hernia System (UHS). Patients were followed up at 3, 6 and 12 months. Before surgery, physical QoL was impaired compared to the normal population and pain was the most commonly reported symptom. All three methods gave similarly good results regarding perioperative course, recovery, complications, recurrence, chronic groin pain, and improvement in QoL after 12 months. All methods seem to be recommendable for IHR under LA. In paper II, all patients included in paper I were analyzed together and followed up at 12 months. Pain was present in 64 % of all patients and 25 % were asymptomatic. Patients were divided into two groups depending on reported pain from their inguinal hernia (P) or not (N). Before surgery, all included patients (T) and patients with pain (P) reported reduced physical QoL (PCS) compared to the normal population while patients without pain (N) did not. At 12 months after surgery, PCS was increased in all patients and did not differ between groups or compared with controls. However, PCS increased significantly more in group P than in N. The occurrence of preoperative pain is an important factor to consider when scheduling a patient for IHR. In paper III, the patients included in paper I were followed up at 3 years. Twenty-six patients (8%) were lost to follow up. The groups were without differences in any of the studied variables at all follow-up occasions. The number of patients reporting pain decreased during the study period to a total of 7 % and the degree of pain was low. PCS improved similarly in all groups to levels not different from the normal population. Five recurrences were identified, equally distributed between groups. The satisfactory results with all three IHR techniques reported after 12 months were sustained at 3 years postoperatively, further implying that none of these are superior over the other. In paper IV, 3 year follow up of the patients included in paper II is reported. The improvement in PCS seen in group P at 12 months was sustained at 3 years postoperatively whereas PCS in group N did not differ compared to before surgery. These observations demonstrate that the relation between preoperative pain and postoperative improvement in QoL at 12 months is sustained also at long-term follow up (3 years). This underscores further that patients with preoperative pain are those who could be expected to benefit the most from IHR. In paper V, data on 95 808 males undergoing IHR with PHS and L between 1999 and 2014 was collected from the Swedish Hernia Register. Primary IHR with PHS had shorter operation time and fewer complications compared with L. Re-operation due to recurrence after primary IHR with PHS was less common but not more complicated compared with after L, and possible to perform by a laparoscopic approach. In conclusion, L, PHS and UHS in primary IHR all give satisfactory results that are sustained over a long time. They can all be recommended for males undergoing primary IHR under LA and daycare surgery. Re-operation due to recurrence after PHS is less common compared with L. Recurrent hernia repair is not more complicated after PHS compared with L. The occurrence of preoperative pain is strongly related to preoperative impairment as well as postoperative improvement of physical QoL. Patients with preoperative pain are those who could be expected to benefit the most from IHR. LIST OF SCIENTIFIC PAPERS I. Magnusson J, Nygren J, Thorell A. Lichtenstein, prolene hernia system, and UltraPro Hernia System for primary inguinal hernia repair: one-year outcome of a prospective randomized controlled trial. Hernia. 2012 Jun; 16(3):277-85. II. Magnusson J, Videhult P, Gustafsson U, Nygren J, Thorell A. Relationship between preoperative symptoms and improvement of quality of life in patients undergoing elective inguinal herniorrhaphy. Surgery. 2014 Jan; 155(1):106-13. III. Magnusson J, Gustafsson U, Nygren J, Thorell A. UltraPro Hernia System, Prolene Hernia System and Lichtenstein for primary inguinal hernia repair: 3-year outcomes of a prospective randomized controlled trial. Hernia. 2016 Oct; 20(5):641-8. IV. Magnusson J, Gustafsson U, Nygren J, Thorell A. Relationship between preoperative symptoms and improvement in quality of life 3 years after inguinal hernia repair. Submitted. V. Magnusson J, Gustafsson U, Nygren J, Thorell A Incidence and treatment of recurrence after primary inguinal hernia repair with Prolene Hernia System and Lichtenstein. In manuscript. LIST OF ABBREVIATIONS EHS European Hernia Society GA General anesthesia HWM Heavyweight mesh IHR Inguinal hernia repair L Lichtenstein LA Local anesthesia LWM Lightweight mesh MCS Mental Component Score N Patients not reporting pain from their inguinal hernia before surgery P Patients reporting pain from their inguinal hernia before surgery PCS Physical Component Score PHS Prolene Hernia System QoL Quality of life SF-36 Short Form 36 SHR The Swedish Hernia Register SIAS The anterior superior iliac spine T Total, all patients taken together TAPP Transabdominal preperitoneal repair TEP Totally extra peritoneal repair UHS UltraPro Hernia System VAS Visual Analogue Scale WW Watchful waiting CONTENTS Introduction . 9 Definition . 9 Inguinal anatomy . 9 Classification . 11 Clinical classification . 12 Epidemiology . 13 Risk factors . 14 Symptoms . 14 Treatment . 15 Indication for surgery . 15 Inguinal hernia repair . 17 Surgical technique . 17 Mesh . 20 Mesh physiology – the foreign body reaction . 21 Mesh material . 21 Mesh weight . 22 Mesh design . 22 Surgical outcome . 25 The Swedish Hernia Register . 25 Complications to ihr . 26 Recurrence . 26 Chronic pain . 26 Discomfort/foreign body sensation . 29 Quality of Life . 30 Aims. 34 Methods . 36 Overview of papers . 36 Patients . 36 Ethics . 38 Power and statistical analysis . 38 Study design and protocols .