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

Simon W Nienhuijs¹  Joop LM Konsten²  Ingrid S Martijnse³  Jeroen Heemskerk⁴  Tanja Lettinga - van de Poll⁵  Jan A Charbon⁶  Bart JM Leenders²  Jeroen EH Ponten¹ 

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

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

Others  :  865759
DOI  :  10.1186/1471-2482-14-33

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

【 摘 要 】

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/Design

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.

Discussion

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.

Trial registration

Netherlands Trail Registration (NTR) www.trialregister.nl 2010 NTR2514 NL33995.060.10

【 授权许可】

   
2014 Ponten et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Stabilini C, Stella M, Frascio M, De Salvo L, Fornaro R, Larghero G, Mandolfino F, Lazzara F, Gianetta E: Mesh versus direct suture for the repair of umbilical and epigastric hernias. Ten-year experience. Ann Ital Chir 2009, 80(3):183-187.
• [2]Malik AM, Jawaid A, Talpur AH, Laghari AA, Khan A: Mesh versus non-mesh repair of ventral abdominal hernias. J Ayub Med Coll Abbottabad 2008, 20(3):54-56.
• [3]Farrow B, Awad S, Berger DH, Albo D, Lee L, Subramanian A, Bellows CF: More than 150 consecutive open umbilical hernia repairs in a major Veterans Administration Medical Center. Am J Surg 2008, 196(5):647-651.
• [4]Abdel-Baki NA, Bessa SS, Abdel-Razek AH: Comparison of prosthetic mesh repair and tissue repair in the emergency management of incarcerated para-umbilical hernia: a prospective randomized study. Hernia 2007, 11(2):163-167.
• [5]Eryilmaz R, Sahin M, Tekelioglu MH: Which repair in umbilical hernia of adults: primary or mesh? Int Surg 2006, 91(5):258-261.
• [6]Arroyo A, Garcia P, Perez F, Andreu J, Candela F, Calpena R: Randomized clinical trial comparing suture and mesh repair of umbilical hernia in adults. Br J Surg 2001, 88(10):1321-1323.
• [7]Christoffersen MW, Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T: Lower reoperation rate for recurrence after mesh versus sutured elective repair in small umbilical and epigastric hernias. A nationwide register study. World J Surg 2013, 37(11):2548-2552.
• [8]Aslani N, Brown CJ: Does mesh offer an advantage over tissue in the open repair of umbilical hernias? A systematic review and meta-analysis. Hernia 2010, 14(5):455-462.
• [9]Askar OM: A new concept of the aetiology and surgical repair of paraumbilical and epigastric hernias. Ann R Coll Surg Engl 1978, 60(1):42-48.
• [10]Sanjay P, Reid TD, Davies EL, Arumugam PJ, Woodward A: Retrospective comparison of mesh and sutured repair for adult umbilical hernias. Hernia 2005, 9(3):248-251.
• [11]Moschcowitz AV: Epigastric hernia without palpable swelling. Ann Surg 1917, 66(3):300-307.
• [12]Gonzalez R, Mason E, Duncan T, Wilson R, Ramshaw BJ: Laparoscopic versus open umbilical hernia repair. JSLS 2003, 7(4):323-328.
• [13]Lau H, Patil NG: Umbilical hernia in adults. Surg Endosc 2003, 17(12):2016-2020.
• [14]Wright BE, Beckerman J, Cohen M, Cumming JK, Rodriguez JL: Is laparoscopic umbilical hernia repair with mesh a reasonable alternative to conventional repair? Am J Surg 2002, 184(6):505-508. discussion 8–9
• [15]Martin DF, Williams RF, Mulrooney T, Voeller GR: Ventralex mesh in umbilical/epigastric hernia repairs: clinical outcomes and complications. Hernia 2008, 12(4):379-383.
• [16]Berrevoet E, de Hemptinne B: Open intraperitoneal mesh repair for umbilical hernias. A technical note. Acta Chir Belg 2009, 109(4):555-558.
• [17]Tollens T, Struyve D, Aelvoet C, Vanrijkel JP: Introducing the Proceed Ventral Patch as a new device in surgical management of umbilical and small ventral hernias: preliminary results. Surg Technol Int 2010, 19:99-103.
• [18]Muschaweck U: Umbilical and epigastric hernia repair. Surg Clin North Am 2003, 83(5):1207-1221.
• [19]Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M: European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia 2009, 13(4):343-403.
• [20]Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T: Outcomes after emergency versus elective ventral hernia repair: a prospective nationwide study. World J Surg 2013, 37(10):2273-2279.
• [21]Lehmann EL: Nonparametrics: Statistical Methods Based on Ranks. 1st edition. Prentice-Hall; 1975:95-106. Revised edition 2006, XVI, 464p. Chapter 2