J R Lambrecht1,2, S G Larsen3, O Reiertsen2,4, A Vaktskjold1,5, L Julsrud6, K Flatmark2,3. 1. Department of Gastroenterological Surgery, Sykehuset Innlandet Hospital Trust, Gjøvik, Norway. 2. Institute of Clinical Medicine, University of Oslo, Oslo, Norway. 3. Department of Gastroenterological Surgery, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway. 4. Department of Digestive Surgery, Akershus University Hospital, Oslo, Norway. 5. Hedmark University College, Elverum, Norway. 6. Department of Radiology, Oslo University Hospital, The Norwegian Radium Hospital, Oslo, Norway.
Abstract
AIM: Parastomal hernia (PSH) is the most common complication of an end-colostomy and about one-quarter of patients need operative repair, which is often unsuccessful. A randomized trial was carried out to compare the results of using mesh or no mesh at the time of formation of a colostomy with the clinical identification of PSH as the primary outcome. METHOD: In this two-centre randomized trial (Oslo University Hospital and Sykehuset Innlandet Hospital Trust, Norway), patients with rectal cancer undergoing open pelvic surgery were randomized to receive a retromuscular synthetic mesh (study group, n = 32) or no mesh (control group, n = 26) at the time of end-colostomy formation. Postoperative follow up was not blinded and included clinical examination and routine CT. RESULTS: The median period of follow up was 40 (range: 84) months. There were no differences in demographic variables or complications between the study and control groups. PSH developed in two patients of the study group and in 12 of the control group [OR = 0.04 (95% CI: 0.01-0.30) and hazard ratio 0.134 (95% CI: 0.030-0.603); P < 0.001]. The number needed to treat to avoid one PSH was 2.5 patients. CT demonstrated an increase over time in the size of the fascial orifice in patients with PSH without mesh prophylaxis, in contrast to a stable size in patients with mesh and in the control patients who did not develop PSH. CONCLUSION: The retromuscular insertion of synthetic mesh at the time of formation of an end-colostomy reduced the risk of PSH. Colorectal Disease
RCT Entities:
AIM: Parastomal hernia (PSH) is the most common complication of an end-colostomy and about one-quarter of patients need operative repair, which is often unsuccessful. A randomized trial was carried out to compare the results of using mesh or no mesh at the time of formation of a colostomy with the clinical identification of PSH as the primary outcome. METHOD: In this two-centre randomized trial (Oslo University Hospital and Sykehuset Innlandet Hospital Trust, Norway), patients with rectal cancer undergoing open pelvic surgery were randomized to receive a retromuscular synthetic mesh (study group, n = 32) or no mesh (control group, n = 26) at the time of end-colostomy formation. Postoperative follow up was not blinded and included clinical examination and routine CT. RESULTS: The median period of follow up was 40 (range: 84) months. There were no differences in demographic variables or complications between the study and control groups. PSH developed in two patients of the study group and in 12 of the control group [OR = 0.04 (95% CI: 0.01-0.30) and hazard ratio 0.134 (95% CI: 0.030-0.603); P < 0.001]. The number needed to treat to avoid one PSH was 2.5 patients. CT demonstrated an increase over time in the size of the fascial orifice in patients with PSH without mesh prophylaxis, in contrast to a stable size in patients with mesh and in the control patients who did not develop PSH. CONCLUSION: The retromuscular insertion of synthetic mesh at the time of formation of an end-colostomy reduced the risk of PSH. Colorectal Disease
Authors: S A Antoniou; F Agresta; J M Garcia Alamino; D Berger; F Berrevoet; H-T Brandsma; K Bury; J Conze; D Cuccurullo; U A Dietz; R H Fortelny; C Frei-Lanter; B Hansson; F Helgstrand; A Hotouras; A Jänes; L F Kroese; J R Lambrecht; I Kyle-Leinhase; M López-Cano; L Maggiori; V Mandalà; M Miserez; A Montgomery; S Morales-Conde; M Prudhomme; T Rautio; N Smart; M Śmietański; M Szczepkowski; C Stabilini; F E Muysoms Journal: Hernia Date: 2017-11-13 Impact factor: 4.739