Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial

BMC Surgery

Study Protocol

Jeroen EH Ponten¹  Simon W Nienhuijs¹  Jeroen Heemskerk²  Jan A Charbon³  Bart JM Leenders⁴  Tanja Lettinga - van de Poll⁵  Ingrid S Martijnse⁶  Joop LM Konsten⁷ 

[1] Departement of Surgery, Catharina Ziekenhuis Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands;Departement of Surgery, Laurentius Ziekenhuis Roermond, Monseigneur Driessenstraat 6, 6043, Roermond, CV, The Netherlands;Departement of Surgery, Maxima Medisch Centrum, De Run 4600, 5504, Veldhoven, DB, The Netherlands;Departement of Surgery, Maxima Medisch Centrum, De Run 4600, 5504, Veldhoven, DB, The Netherlands;Departement of Surgery, VieCuri Medisch Centrum, Tegelseweg 210, 5912, Venlo, BL, The Netherlands;Departement of Surgery, St. Jans Gasthuis Weert, Vogelsbleek 5, 6001, BE Weert, The Netherlands;Departement of Surgery, TweeSteden Ziekenhuis Tilburg, Dr. Deelenlaan 5, 5042, Tilburg, AD, The Netherlands;Departement of Surgery, VieCuri Medisch Centrum, Tegelseweg 210, 5912, Venlo, BL, The Netherlands;

关键词: Umbilical;    Epigastric;    Hernia;    Herniorraphy;    Mesh repair;    Proceed Ventral Patch;    Complications;    Pain;    Recurrence;    Costs;   

DOI  :  10.1186/1471-2482-14-33

 received in 2013-08-10, accepted in 2014-05-13,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundEvidence is accumulating that, similar to other ventral hernias, umbilical and epigastric hernias must be mesh repaired. The difficulties involved in mesh placement and in mesh-related complications could be the reason many small abdominal hernias are still primary closed. In laparoscopic repair, a mesh is placed intraperitoneally, while the most common procedure is open surgery is pre-peritoneal mesh placement. A recently developed alternative method is the so-called patch repair, in this approach a mesh can be placed intraperitoneally through open surgery. In theory, such patches are particularly suitable for small hernias due to a reduction in the required dissection. This simple procedure is described in several studies. It is still unclear whether this new approach is associated with an equal risk of recurrence and complications compared with pre-peritoneal meshes. The material of the patch is in direct contact with intra-abdominal organs, it is unknown if this leads to more complications. On the other hand, the smaller dissection in the pre-peritoneal plane may lead to a reduction in wound complications.Methods/Design346 patients suffering from an umbilical or epigastric hernia will be included in a multi-centre patient-blinded trial, comparing mesh repair with patch repair. Randomisation will take place for the two operation techniques. The two devices investigated are a flat pre-peritoneal mesh and a Proceed Ventral Patch®. Stratification will occur per centre. Post-operative evaluation will take place after 1, 3, 12 and 24 months. The number of complications requiring treatment is the primary endpoint. Secondary endpoints are Verbal Descriptor Scale (VDS) pain score and VDS cosmetic score, operation duration, recurrence and costs. An intention to treat analysis will be performed.DiscussionThis trial is one of the first in its kind, to compare different mesh devices in a randomized controlled setting. The results will help to evaluate mesh repair for epigastric an umbilical hernia, and find a surgical method that minimizes the complication rate.Trial registrationNetherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10

【 授权许可】

CC BY   
© Ponten et al.; licensee BioMed Central Ltd. 2014