Design of clinical investigations for hernia meshes

doi:10.3877/cma.j.issn.1674-392X.2020.04.002

Abstract

Abstract:

Hernia meshes are permanent implants. As a result, the safety and effectiveness of hernia meshes are crucial to patients' quality of life. Conducting clinical investigations or trials are one of the important methods to evaluate the safety and effectiveness of hernia meshes. Based on the technical evaluation of clinical data of multiple hernia mesh products as well as analysis of relevant literatures, this article discusses key principles and factors regarding the design of clinical investigations for hernia meshes. Specific recommendations are also provided to sponsors and clinical investigators for hernia meshes clinical studies.

Key words: Hernia mesh, Clinical investigation, Medical device, Technical evaluation

Wenbo Liu, Xinli Shi, Peng Zhao, Lina Xing, Shupei Zhang, Juli Tang, Changjin Huang. Design of clinical investigations for hernia meshes[J]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2020, 14(04): 327-330.

/ / Recommend

Add to citation manager EndNote|Ris|BibTeX

URL: https://zhshfbwkzz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.1674-392X.2020.04.002

https://zhshfbwkzz.cma-cmc.com.cn/EN/Y2020/V14/I04/327

References 35

[1]	Kohler A, Lavanchy JL, Lenoir U, et al. Effectiveness of prophylactic intraperitoneal mesh implantation for prevention of incisional hernia in patients undergoing open abdominal surgery: a randomized clinical trial[J]. JAMA Surg, 2019, 154(2): 109-115.
[2]	Gokcal F, Morrison S, Kudsi OY. Short-term comparison between preperitoneal and intraperitoneal onlay mesh placement in robotic ventral hernia repair[J]. Hernia, 2019, 23(5): 957-967.
[3]	Kokotovic D, Bisgaard T, Helgstrand F. Long-term recurrence and complications associated with elective incisional hernia repair[J]. JAMA, 2016, 316(15): 1575-1582.
[4]	Lambrecht JR, Larsen SG, Reiertsen O, et al. Prophylactic mesh at end-colostomy construction reduces parastomal hernia rate: a randomized trial[J]. Colorectal Dis, 2015, 17(10): O191-197.
[5]	Cross AJ, Buchwald PL, Frizelle FA, et al. Meta-analysis of prophylactic mesh to prevent parastomal hernia[J]. Br J Surg, 2017, 104(3): 179-186.
[6]	Kaufmann R, Halm JA, Eker HH, et al. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial[J]. Lancet, 2018, 391(10123): 860-869.
[7]	Jun Z, Na J, Zhen C, et al. Single-incision laparoscopic approach for linea alba hernia in children[J]. J Minim Access Surg, 2019, 15(1): 42-45.
[8]	Barnes TG, Mcwhinnie DL. Laparoscopic spigelian hernia repair: a systematic review[J]. Surg Laparosc Endosc Percutan Tech, 2016, 26(4): 265-270.
[9]	Pulido J, Reitz S, Gozdanovic S, et al. Laparoscopic repair of chronic traumatic diaphragmatic hernia using biologic mesh with cholecystectomy for intrathoracic gallbladder[J]. JSLS, 2011, 15(4): 546-549.
[10]	Zhang C, Liu D, Li F, et al. Systematic review and meta-analysis of laparoscopic mesh versus suture repair of hiatus hernia: objective and subjective outcomes[J]. Surg Endosc, 2017, 31(12): 4913-4922.
[11]	Howell RS, Fazzari M, Petrone P, et al. Paraesophageal Hiatal Hernia Repair With Urinary Bladder Matrix Graft[J]. JSLS, 2018, 22(2): 1-6.
[12]	Musters GD, Bemelman WA, Bosker RJ, et al. Randomized controlled multicentre study comparing biological mesh closure of the pelvic floor with primary perineal wound closure after extralevator abdominoperineal resection for rectal cancer(BIOPEX-study)[J]. BMC Surg, 2014, 58(14): 58.
[13]	Reginelli A, Di Grezia G, Gatta G, et al. Role of conventional radiology and MRi defecography of pelvic floor hernias[J]. BMC Surg, 2013, 13(Suppl 2): 1-7.
[14]	Muysoms F, Campanelli G, Champault GG, et al. EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair[J]. Hernia, 2012, 16(3): 239-250.
[15]	Li J, Wang X, Feng X, et al. Comparison of open and laparoscopic preperitoneal repair of groin hernia[J]. Surg Endosc, 2013, 27(12): 4702-4710.
[16]	Soliani G, De Troia A, Portinari M, et al. Laparoscopic versus open incisional hernia repair: a retrospective cohort study with costs analysis on 269 patients[J]. Dis Esophagus, 2017, 21(4): 609-618.
[17]	Andresen K, Rosenberg J. Open preperitoneal groin hernia repair with mesh: A qualitative systematic review[J]. Am J Surg, 2017, 213(6): 1153-1159.
[18]	Zwaans WA, Perquin CW, Loos MJ, et al. Mesh Removal and Selective Neurectomy for Persistent Groin Pain Following Lichtenstein Repair[J]. World J Surg, 2017, 41(3): 701-712.
[19]	Gordon AC, Gillespie C, Son J, et al. Long-term outcomes of laparoscopic large hiatus hernia repair with nonabsorbable mesh[J]. Dis Esophagus, 2018, 31(5).
[20]	Varkarakis G, Daniels J, Coker K, et al. Effects of comorbidities and implant reinforcement on outcomes after component reconstruction of the abdominal wall[J]. Ann Plast Surg, 2010, 64(5): 595-597.
[21]	Sasse KC, Lambin JH, Gevorkian J, et al. Long-term clinical, radiological, and histological follow-up after complex ventral incisional hernia repair using urinary bladder matrix graft reinforcement: a retrospective cohort study[J]. Hernia, 2018, 22(6): 899-907.
[22]	Delliturri A, Chiba S, Brichkov I, et al. Laparoscopic repair of a peritoneopericardial diaphragmatic hernia after a convergent procedure for the treatment of atrial fibrillation[J]. J Thorac Dis, 2017, 9(9): 767-770.
[23]	Colavita PD, Belyansky I, Walters AL, et al. Umbilical hernia repair with mesh: identifying effectors of ideal outcomes[J]. Am J Surg, 2014, 208(3): 342-349.
[24]	Shubinets V, Carney MJ, Colen DL, et al. Management of infected mesh after abdominal hernia repair: systematic review and single-institution experience[J]. Ann Plast Surg, 2018, 80(2): 145-153.
[25]	Morales-Conde S, Suarez-Artacho G, Socas-Macias M, et al. Retroprosthetic seroma after laparoscopic ventral hernia repair: incidence, risk factors and clinical significance[J]. Hernia, 2015, 19(6): 943-947.
[26]	Han HJ, Kim CY, Choi SB, et al. Sigmoid colon fistula following totally extraperitoneal hernioplasty: an improper treatment for mesh infection or iatrogenic injury?[J]. Hernia, 2010, 14(6): 655-658.
[27]	Deasis FJ, Lapin B, Gitelis ME, et al. Current state of laparoscopic parastomal hernia repair: A meta-analysis[J]. World J Gastroenterol, 2015, 21(28): 8670-8677.
[28]	Bhullar JS, Gayagoy J, Chaudhary S, et al. Delayed presentation of a bowel Bovie injury after laparoscopic ventral hernia repair[J]. JSLS, 2013, 17(3): 495-498.
[29]	Verhagen T, Zwaans WA, Loos MJ, et al. Randomized clinical trial comparing self-gripping mesh with a standard polypropylene mesh for open inguinal hernia repair[J]. Br J Surg, 2016, 103(7): 812-818.
[30]	Uzzaman MM, Ratnasingham K, Ashraf N. Meta-analysis of randomized controlled trials comparing lightweight and heavyweight mesh for Lichtenstein inguinal hernia repair[J]. Hernia, 2012, 16(5): 505-518.
[31]	Vedak P, St John J, Watson A, et al. Delayed type IV hypersensitivity reaction to porcine acellular dermal matrix masquerading as infection resulting in multiple debridements[J]. Hernia, 2017, 21(3): 489-492.
[32]	Hofbauer C, Andersen PV, Juul P, et al. Late mesh rejection as a complication to transabdominal preperitoneal laparoscopic hernia repair[J]. Surg Endosc, 1998, 12(9): 1164-1165.
[33]	Bansal VK, Krishna A, Manek P, et al. A prospective randomized comparison of testicular functions, sexual functions and quality of life following laparoscopic totally extra-peritoneal(TEP) and trans-abdominal pre-peritoneal(TAPP) inguinal hernia repairs[J]. Surg Endosc, 2017, 31(3): 1478-1486.
[34]	Cox TC, Huntington CR, Blair LJ, et al. Quality of life and outcomes for femoral hernia repair: does laparoscopy have an advantage?[J]. Hernia, 2017, 21(1): 79-88.
[35]	Silecchia G, Cavallaro G, Raparelli L, et al. Titanium versus absorbable tacks comparative study(TACS): a multicenter, non-inferiority prospective evaluation during laparoscopic repair of ventral and incisional hernia: study protocol for randomized controlled trial[J]. Trials, 2015, 16: 249.

Please choose a citation manager

Content to export