Philippe M Glauser1,2, Philippe Brosi1,3, Benjamin Speich1,4, Samuel A Käser1,3, Andres Heigl1, Robert Rosenberg1, Christoph A Maurer5,6. 1. Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland. 2. Department of General Surgery, University Hospital Basel, Basel, Switzerland. 3. Department of Visceral and Transplant Surgery, University Hospital Zürich, Zurich, Switzerland. 4. University of Basel and University Hospital Basel, Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, Basel, Switzerland. 5. Department of Surgery, Hospital of Baselland, University of Basel, Liestal, Switzerland. christoph.maurer@hin.ch. 6. Professor of Surgery, Former Chairman of Surgical Department of Liestal, Hirslanden Private Clinic Group, Hirslanden Clinic Beau-Site, Schänzlistrasse 1, 3000, Bern, Switzerland. christoph.maurer@hin.ch.
Abstract
OBJECTIVES:Incisional hernia, a serious complication after laparotomy, is associated with high morbidity and costs. This trial examines the value of prophylactic intraperitoneal onlay mesh to reduce the risk of incisional hernia after a median follow-up time of 5.3 years. METHODS: We conducted a parallel group, open-label, single center, randomized controlled trial (NCT01003067). After midline incision, the participants were either allocated to abdominal wall closure according to Everett with a PDS-loop running suture reinforced by an intraperitoneal composite mesh strip (Group A) or the same procedure without the additional mesh strip (Group B). RESULTS: A total of 276 patients were randomized (Group A = 131; Group B = 136). Follow-up data after a median of 5.3 years after surgery were available from 183 patients (Group A = 95; Group B = 88). Incisional hernia was diagnosed in 25/95 (26%) patients in Group A and in 46/88 (52%) patients in Group B (risk ratio 0.52; 95% CI 0.36-0.77; p < 0.001). Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1 years. Between the second- and fifth-year follow-up period, no complication associated with the mesh could be detected. CONCLUSION: The use of a composite mesh in intraperitoneal onlay position significantly reduces the risk of incisional hernia during a 5-year follow-up period. TRIAL REGISTRATION NUMBER: Ref. NCT01003067 (clinicaltrials.gov).
RCT Entities:
OBJECTIVES: Incisional hernia, a serious complication after laparotomy, is associated with high morbidity and costs. This trial examines the value of prophylactic intraperitoneal onlay mesh to reduce the risk of incisional hernia after a median follow-up time of 5.3 years. METHODS: We conducted a parallel group, open-label, single center, randomized controlled trial (NCT01003067). After midline incision, the participants were either allocated to abdominal wall closure according to Everett with a PDS-loop running suture reinforced by an intraperitoneal composite mesh strip (Group A) or the same procedure without the additional mesh strip (Group B). RESULTS: A total of 276 patients were randomized (Group A = 131; Group B = 136). Follow-up data after a median of 5.3 years after surgery were available from 183 patients (Group A = 95; Group B = 88). Incisional hernia was diagnosed in 25/95 (26%) patients in Group A and in 46/88 (52%) patients in Group B (risk ratio 0.52; 95% CI 0.36-0.77; p < 0.001). Eighteen patients with asymptomatic incisional hernia went for watchful waiting instead of hernia repair and remained free of symptoms after of a median follow-up of 5.1 years. Between the second- and fifth-year follow-up period, no complication associated with the mesh could be detected. CONCLUSION: The use of a composite mesh in intraperitoneal onlay position significantly reduces the risk of incisional hernia during a 5-year follow-up period. TRIAL REGISTRATION NUMBER: Ref. NCT01003067 (clinicaltrials.gov).
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