title: Mesh Or Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS trial): study protocol for a multi-centre patient blinded randomized controlled trial.
abstract: BACKGROUND
  Evidence 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
  346 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  Netherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10.
authors.affiliation: Departement of Surgery, Catharina Ziekenhuis Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven, The Netherlands. jeroen.ponten@catharinaziekenhuis.nl.
authors.forename: Jeroen E H
authors.initials: JE
authors.lastname: Ponten
authors.forename: Bart J M
authors.initials: BJ
authors.lastname: Leenders
authors.forename: Jan A
authors.initials: JA
authors.lastname: Charbon
authors.forename: Tanja
authors.initials: T
authors.lastname: Lettinga-van de Poll
authors.forename: Jeroen
authors.initials: J
authors.lastname: Heemskerk
authors.forename: Ingrid S
authors.initials: IS
authors.lastname: Martijnse
authors.forename: Joop L M
authors.initials: JL
authors.lastname: Konsten
authors.forename: Simon W
authors.initials: SW
authors.lastname: Nienhuijs
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D005500:Follow-Up Studies; D006555:Hernia, Ventral / Q000601:surgery*; D059685:Herniorrhaphy / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D057194:Intention to Treat Analysis; D008875:Middle Aged; D010147:Pain Measurement; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D012008:Recurrence; D016037:Single-Blind Method; D013526:Surgical Mesh; D016896:Treatment Outcome; D055815:Young Adult